Podcasts about ctti

About The SMC ShowWe interview the "Smart Money" - money managers and CEO's of publicly traded companies for timeless advice. Visit SmartMoneyCircle.com To Learn MoreGrant Cardone Shares The #1 Most Important Thing He's Learned About Money & Other Timeless LessonsWebsite:https://cardonecapital.com/GuestGrant Cardone CEO Cardone CapitalCardone Training TechnologiesBioGRANT CARDONEPRIVATE EQUITY FUND MANAGER & REAL ESTATE INVESTORCEO of Cardone Capital and Cardone Training Technologies, Inc.Grant Cardone owns and operates over seven privately held companies, and a private equity real estate firm, Cardone Capital, with a multifamily portfolio of assets worth over $5 Billion. He is one of the Top Crowdfunders in the world, raising over $1.63 Billion in equity via social media. Cardone is featured on Season 2 of Discovery Channel's Undercover Billionaire, where he takes on the challenge of building a million-dollar business in 90 days. Grant is also a New York Times bestselling author of If You're Not First You're Last and bestselling author of 11 business books, including The 10X Rule, which led to Cardone establishing the 10X Global Movement featuring the 10X Growth Conference and 10X Wealth Conference, which is known as the most influential business and entrepreneur conference in the world.For over 35 years, Grant Cardone and Cardone Training Technologies, Inc. (CTTI), a global consulting firm have been trusted providers of comprehensive business training and consulting. The online business and sales educational platforms Cardone created serve over 850,000 individuals, businesses and Forbes 100 clients throughout the world. CTTI extensive offerings include online courses, live workshops, on-demand content, and personalized coaching, all meticulously designed to cater to the evolving needs of modern organizations. From new-hire training that accelerates onboarding to continuous education certifications as your company and sales team grow, we provide unmatched online sales training. With more than 8,000 fully interactive video segments and 24/7 access and support, CTTI enables companies and individuals to leverage the unparalleled expertise of Grant Cardone and Cardone Training Technologies Inc. to achieve exceptional business success.For more information, visit https://www.cardonetraining.com or follow us on social media.Voted the top Marketing Influencer to watch by Forbes, Cardone uses his massive 16 million+ following to give back via his Grant Cardone Foundation, a non-profit organization dedicated to mentoring underprivileged and troubled youth in financial literacy.

In this episode, Vera spoke with Morgan Hanger, Executive Director of the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership dedicated to improving the quality and efficiency of clinical trials, aiming to transform the industry by 2030. Hanger shares her career journey, from her roles at PatientsLikeMe and Memorial Sloan Kettering Cancer Center, to leading CTTI. She explains how her patient-centered focus has shaped CTTI's approach to its Transforming Trials 2030 initiative. Hanger addresses the major challenges in clinical trials today, including regulatory complexities and the need for better data transparency. She explains how CTTI is tackling these issues through collaboration and innovative trial designs, like decentralized and adaptive trials, which aim to improve efficiency and inclusivity. Hanger encourages new clinical trial professionals to embrace innovation and stay patient-focused. She hopes her work at CTTI will influence the development of a clinical trial system that is more efficient, inclusive and better aligned with patient needs. Tune in to learn how CTTI is leading efforts to reshape clinical trials. For more life science and medical device content, visit the Xtalks Vitals homepage. https://xtalks.com/vitals/ Follow Us on Social Media Twitter: https://twitter.com/Xtalks Instagram: https://www.instagram.com/xtalks/ Facebook: https://www.facebook.com/Xtalks.Webinars/ LinkedIn: https://www.linkedin.com/company/xtalks-webconferences YouTube: https://www.youtube.com/c/XtalksWebinars/featured

2024-01-26 Hosts Craig Lipset, Amir Kalali, and Jane Myles were joined by the fabulous Stacy Hurt (Parexel) to discuss the importance of the Chief Patient Officer (CPO) role in the life sciences industry. A great conversation was had about how the CPO is uniquely positioned to improve patient access and experience. A link to the CTTI paper on ROI & engagement that was discussed during the session is linked here.Follow the Decentralized Trials & Research Alliance (DTRA) on LinkedIn and Twitter. Learn more about Membership and our work at www.dtra.org.

Noah and John talk with Sally Okun, the Executive Director of CTTI and a leader in patient centric care. We discuss what it means practically to listen to patients and clinical trial participants and how their experiences can become data that shape policy and evolve our industry.Find Out MoreSally OkunClinical Research EvolvedNoah Goodson, PhDJohn ReitesKyle RickettsAbout the ShowOn Clinical Research Evolved, hosts Dr. Noah Goodson and John Reites talk with subject matter experts from across the life science industry to discuss the history, innovations, and future of clinical research as it evolves from ideas to actions. 

The last two years have been driving many discussions of the need for change in the pharmaceutical industry, particularly in the clinical trial arena. Discussions have not always led to actions, however. Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. As we look towards 2022, I believe we will record this as a year of make it so. The time for moving on from debate is here, as patients are demanding action and forward momentum on today's episode of People Always, Patients Sometimes, our host Janet Kennedy has a conversation with the new executive director of the Clinical Trials Transformation Initiative, Sally Okun. Sally brings a unique and essential perspective to CTTI, as a former nurse and VP of Patients Like Me. They have a detailed discussion of the Transforming Trials 2030 initiative, one that Spencer Health Solutions is 100% behind. I hope you enjoy this episode of People Always, Patients Sometimes.   Janet Kennedy: (00:59) It's very exciting for me to have today's guest. Sally Okun is now the executive director of the Clinical Trials Transformation Initiative. The last time I spoke with her was on the Get Social Health podcast, where she was the vice president of Patients Like Me. So interesting that we're going to have another conversation, but in a totally different role, and yet, still very patient centric. So please join me in welcoming Sally Okun to the People Always, Patients Sometimes podcast. Sally, I'm so glad to have you here. I know it's been very, very odd over the past few years in working and collaborating and life transitions, but we had an opportunity to talk to your predecessor, Pamela Tenaerts, who was the executive director of the Clinical Trials Transformation Initiative. We spoke to her pre-COVID. So now we're in the middle and maybe hopefully heading towards the end. And there are a lot of exciting things happening at CTTI. So welcome to the podcast, and I'd love to hear a little bit about how you ended up joining CTTI.   Sally Okun: (02:09) Janet, it's so nice to be here, and I really appreciate the opportunity to talk more about the Clinical Trials Transformation Initiative, and certainly the shoes that Pam left are large, and I'm still trying to find ways of filling them, and I think that's gonna take some time. How did I get to my current role? Well, interestingly enough, I had left Patients Like Me in 2020 and I was working on a variety of interesting projects at the time across the health spectrum. You know, I was consulting on a variety of different things and also enjoying some newfound freedom of semi-retirement, which was an interesting experience for the first time in my career. You know, by about mid 2021, maybe in light of the time that we were all spending at home as opposed to spending out enjoying each other's company socially or professionally, I started thinking more and more about the next chapter of my professional career.   Sally Okun: (02:57) So it wasn't long after that, that I was approached about the position of executive director at CTTI. And frankly, initially I didn't see the fit for me. You know, I've not spent my career in clinical trial work. I've spent a lot of my career in research and clinical research with patients and others, but hadn't really focused specifically on clinical trials and the clinical trial enterprise. So at first I really wasn't exactly sure it would be a good fit for me. However, after talking with some trusted colleagues and others, including the chairs of CTTI's executive committee, I was truly intrigued by the organization's impressive portfolio of work. I really hadn't been aware of just how much they have done over the last 15 years, 14 years, in terms of contributing to the improvement overall of the clinical trial experience, not just for participants, but for investigators as well as sponsors and others.   Sally Okun: (03:48) So, you know, I then looked a little more closely at the transforming trials vision, and I thought, you know what, here's an organization that is setting goals as a priority to be seeing clinical trials as patient centric and easily accessible as its number one pillar. And I thought, well, you know what, I think maybe this fit might be just right. So I spent a bit more time thinking about it and then made the leap in October of just a couple months ago - just hit my two month anniversary.   Janet Kennedy: (04:13) You mentioned something just now about the Transforming Trials 2030 program. What is that?   Sally Okun: (04:20) Well, you know, a couple of years ago, again, under Pam's leadership, they discussed the need to set some milestones to really stop sort of talking about improving clinical trials, but actually putting some stakes in the ground or pillars up to suggest that we need to have a goal for that transformation; that have to have things that we're working towards as a community in order to be able to achieve a better experience for everyone involved in clinical trials.   Sally Okun: (04:49) So what came out of that initial discussion was a set of five pillars that actually articulate quite specifically what we believe clinical trials should be like by 2030. And each one of them has a host of different objectives beneath the goal, that actually really describe how we might ultimately get to the point where we can say, "Yes, indeed, we have clinical trials that are now patient centered and easily accessible," for example, for the first pillar. But each one of them is complex. Each one of them requires a lot of understanding of what needs to get unpacked to better get at the kinds of things that need to get changed. So we are in the process right now of beginning a strategic plan for doing just that: taking each of the pillars and starting to think about how will we know that we've achieved success on this pillar? What will be the metrics we need to start thinking about for those.   Janet Kennedy: (05:42) Alright. So let's do some metrics here. What are the other four pillars?   Sally Okun: (05:46) Number one, as I said, is that clinical trials will be patient centered and easily accessible. And if we don't reach that, then some of the others are almost irrelevant. So that is actually the place to begin. But then the second one is that they're fully integrated into health processes. So that gives us an opportunity to really begin thinking about the continuously learning health system, where we embed within the care environment, the opportunity to research and learn, and then put that learning back into the care environment again, so that we have a full circle loop. The third one is that they are designed with a quality approach, and CTTI has done an incredible amount of work on something called quality by design.   Sally Okun: (06:27) It has a whole set of recommendations around how to determine how the quality of your trial based on a variety of different things - whether it's your recruitment numbers or other aspects of what the trial efficiency looks like. The fourth one is that clinical trials take full advantage; they maximally leverage all available clinical and nonclinical data, including data that's collected now with digital technologies to ensure that we max - minimize - the collection burden of getting data and actually improve the opportunity to make data more meaningful and impactful as part of the trial experience. And then lastly, although not least, is that clinical trials contribute knowledge to how to prevent diagnosis and treat disease. And that becomes something that's an objective around improving population health and the health of our people.   Janet Kennedy: (07:12) Okay. Those are very large topics, very large goals. Who is the Clinical Trials Transformation Initiative? Who's going to do this work?   Sally Okun: (07:23) We are a group of people who have come together within the organization that includes project managers who oversee our projects, and then strategic and engagement and communications team that oversees all of our communications with our steering committee members in our member organizations. So to give you an idea of what that structure looks like: we have a steering committee that includes about 80 organizations who are actually members of CTTI, Clinical Trials Transformation Initiative, and they commit to have a person assigned as a steering committee representative. So as we begin to think about tackling a new topic or a new initiative, we go to the steering committee and we make available to them the opportunity to join the project team. That project team then starts to create the infrastructure for accomplishing that project, which can include, first of all, the project plan and setting the aims and the objectives.   Sally Okun: (08:17) In many ways, it's creating a research study for the topic under consideration with that. Then they set out to consider what's the literature already say? Who are the expert people we need to be speaking to? So there's a lot of qualitative interviewing that goes on as part of the social science team from the Duke Clinical Research Institute; that is a connection for our team to be able to work with. And then the findings from those interviews begin to shape the recommendations that will come out about a particular topic area. For example, thinking about trials in healthcare setting; what do we need to know about the various barriers for those and the opportunities for those as well as the current landscape within which the clinical experience might or might not include participation in research activities? So there's an entire project management approach that is put on any topic we tackle.   Sally Okun: (09:08) The problem with it; it's an incredible opportunity for us to be able to map out these topics and really think about the issues as a group, but it's a labor intensive and time consuming. It can take up to two years to complete some of our projects because they are so intense in terms of diving deep into the problem and trying to come up with resources and tools to address it. So where we are faced today is thinking about how will transformed trials by 2030 if we continue to take this much time to get through our project? Which is why we're now starting to focus quite specifically on each of the pillars, and in many ways, making a project around that pillar. So if we take the first one, for example, and we say trials will be patient centered and easily accessible. The first question I have is how will we know that?   Sally Okun: (09:55) So we're starting to look at ways of being able to measure whether clinical trials today are, or are not patient centered. And that can be evidenced by whether or not patients were involved in the design of the trial, which is work we've already done in some other projects that we've done. Also, how is the enrollment handled? Did it include a diverse population? A variety of different ways of able to measure patient centricity around a trial. But you're right, each one of these has a lot embedded in it and our strategic approach to it right now is taking each one. I've assigned a project manager to every pillar. And we are now just beginning the process of setting a goal for the metrics for each one, and then identifying where we will go next in terms of what resources we know exist already within CTTI that we can map to it, and then what resources may exist in related efforts, whether it's transCelerate or the Multi-Regional Clinical Trials Initiative, others that are related efforts and aligned with our work, and starting to see where their resources could help to get us closer to realizing that particular vision or that pillar.   Janet Kennedy: (10:59) Now, I know your members represent nonprofit organizations, for profit organizations; I think you even have some patient volunteers who are part of your program. But where does the funding come from to make these things happen?   Sally Okun: (11:12) Well, you know, we are a public/private partnership with the FDA. We have been very fortunate to have an excellent relationship with the FDA over the last number of years, their interest in having us be available to tackle some of the more problematic issues that they are not in a position to do on their own. So the funding comes through a grant that supports that public/private partnership. Also our members, depending on the type of organization or company that they are, pay a membership fee to participate. And so that helps to offset some of the costs as well for maintaining our team and the other resources that we put to bear to get the work done on a regular basis.   Janet Kennedy: (11:50) And then how does it actually get done? So if you come up with these guidelines or these recommendations, is there a commitment on the part of these for-profit organizations that they'll actually start to modify, or is the science and the evidence so evident that it makes no sense not to implement these changes?   Sally Okun: (12:10) Yeah, that's a good question. It would be nice if everything seemed that intuitive. That yes, indeed, this is something we ought to be doing because it's just the right thing to do, right? And many of our recommendations would fall into that category. And I think many of our organizations commit to ensuring that they make attempts to incorporate those recommendations into the work that they're doing. Right now, we do have a method of identifying as part of the project itself. Towards the latter part of it, opportunities for adoption of the recommendation. So what that project team will think about is, so now what? How will we see these things come to life in the real world? So opportunities for providing some insights into how they might be best adopted are offered as part of the overall project deliverable at the end of the day. Now at the same time, we don't have an accountability measure to be able to say, "Yes, we believe these recommendations should be incorporated into the clinical trial on this particular topic area, and we expect that you will deliver on that."   Sally Okun: (13:09) So that is, I think, a professional courtesy that we afford to our members to say, "We appreciate that you committed a lot of time to helping us get to the point where we have these recommendations; now what we'd like to ask of you is to start sharing your experiences of using these recommendations and resources." So we actually - just this past year created the Building Better Trials case study exchange. And it's a portal where our members and non-members actually can contribute their experiences of using CTTI tools and resources for a particular purpose within their organization to advance or improve the efficiency and quality of clinical trial experiences. And those have been great. It's a wonderful opportunity for us to showcase how members and even non-members, as I said, use the CTTI resources in a way that actually do have an impact. And it's also a place where, from my perspective, most importantly, we can have continuous and shared learning. So what one group might have learned as a result of incorporating the recommendations for a single IRB, for example - that can be brought forth for others who are now facing the need to do that, the kinds of challenges and other ways that the organization actually met the recommendations that were set forth.   Janet Kennedy: (14:23) And for those listening, if you visit the website and go to this podcast episode, I'll make sure that there is a link there. Tell me a little bit about the patient's role; obviously you come in with a very unique background and a very wrong patient-centric experience and support system set up. So how are patients involved? Because let's face it, they don't have the kind of money it would take to join an organization. They may not even have the time to commit to some of the work that's being done here. But how do you incorporate the patient voice into the work of CTTI?   Sally Okun: (14:55) Well, it is an incredibly important voice and we pay a lot of attention to ensuring that we have mechanisms to get that. We actually have three members of the steering committee who are patient representatives and they come into the role with that responsibility. So they are - similar to being an organization - they have been identified through an application process as people who are willing and interested in contributing in a very substantive way to our understanding of what it means to be a patient in the context of clinical trials. So there's three of them on our steering committee itself, and one of them is actually a caregiver and the other two are patients, one living with breast cancer and the other with ALS, or Lou Gehrig's disease. And so the opportunity for them to be a part of the steering committee team, when a project comes up is wide open.   Sally Okun: (15:44) So we're always looking for ways of having them be involved. Now at the same time, we have many patient organizations that are members. You're so right; these organizations and patients individually don't have the resources to be able to pay a membership fee that would be sort of out of their range. Our membership fees vary on a sliding scale depending on the organizational type and the revenue that those organizations have. So a patient organization would - I think the highest amount is a $500 membership fee. And I think, you know, obviously, thinking about other organizations that may even be a challenge for, we would certainly work with them and talk with them about how we could make a membership opportunity come to fruition. So the other thing that we do is we do have a relationship with the FDA in terms of being able to help them support their patient engagement collaborative.   Sally Okun: (16:31) Now, this is a group of sixteen individuals who again, apply to be a part of the patient collaborative, and we actually help support that group. And it's an opportunity for us also to work more closely with FDA on how they can have access to patients in a way that helps them better understand the patient experience. So I think we try really hard to ensure that all of our projects have a patient representative on them, whether it's a patient individual or a patient group, or potentially having some relationship back to the patient engagement collaborative at FDA itself.   Janet Kennedy: (17:03) I think the work you're doing is so exciting and so important. I worry a little bit that your projects are huge, and you do have, you know, your goal of transforming trials by 2030. However, you know, in order to get there, you gotta take a few steps. So will you be releasing work along the way?   Sally Okun: (17:24) You know, as I said, one of the things that I did right from the very first day I arrived was to start talking with the team about measurement and data. As you know, coming out of Patients Like Me, one of the things that was a hallmark of our work with data, and we just felt like we needed to be data driven in order to be able to answer important questions for patients. It's no different here. It's very much the same. In order to be able to achieve these lofty goals of this transforming trials vision, we have to know where we're at now. What's the baseline data we know about the percentage of trials that are currently patient-centric? I really have no idea. We have to start thinking about ways of being able to find metrics that will tell us some of that. What's the evidence of a trial being patient-centric?   Sally Okun: (18:04) And there are tools out there that we will be starting to inventory and start to determine whether or not these will be ones that we'll put into the ways that we think about this. The short answer to your question is my objective with taking each pillar and intentionally unpacking it, is to better understand where do we need to begin? How will we know that we're making some progress? And that will be metrics and data. And then what are the resources that we are gonna need to start thinking about beyond just adoption? So it's not simply gonna be enough to say, "Here's the recommendations we're making about patient-centric trials for you to be able to, you know, have available to you." We'd like very much to start thinking about the ways of being able to have a bit of a scorecard on that. How do we know we've made a difference?   Sally Okun: (18:49) How do we know that some of the work and the learnings that we've been generating are actually going to translate into something that happens at the clinical trial level itself? And those are still things in development, but they are very important, to me personally, as part of my own work, but also for me as the executive director of the organization today to say, "Let's start measuring how well we're doing on every one of these," and better understand at what point we believe we've actually shifted the needle enough to be able to say, "We're reaching closer to that goal." Now, will we get there by 2030 on every one of them? You know what, I'm gonna remain optimistic. But I also recognize that there's so much that can happen between now and then that could interrupt our progress. And just taking into example, the COVID pandemic over the last year and a half, that stopped so many other kinds of research because we had to focus on that.   Sally Okun: (19:40) Our hope is that in some of the things that we've taken away and learned from that, as we look at each of these pillars, we wanna be able to say, will this stand up during a time of public emergency. Also are the things that we're coming up with applicable beyond the US. That's another important aspect that we have to start thinking about; clinical trials take place everywhere. And in fact, more people are recruited outside of the US than they are in the US. So we have to be thinking about that quite intentionally. And then lastly, the one area that we have not worked specifically in integrating into our prior projects is how can technology itself enable the success on this particular pillar? What are the opportunities that are available today and even tomorrow or two years from now that weren't available previously, that we can start to take advantage of that, help us move that goal closer to achieving it?   Janet Kennedy: (20:30) Well, you come in at an interesting time where you probably were interviewing during the process of all the stopping and starting and having to rethink about how clinical trials were going to go ahead in the midst of the pandemic. And now you've started when, you know, we thought we saw the light at the end of the tunnel and things have managed to pick up, and a lot of companies were able to pivot and use digital technology to move some clinical trials forward. However, I'm curious to know, as you come in and you were getting feedback from your steering committees, did you hear them say that this pandemic has accelerated our vision for decentralized clinical trials for the use of digital health technology?   Sally Okun: (21:14) Yes. And I may not have been hearing that because I wasn't here at the time, but definitely the projects that we had that as a result of some of the work being done through COVID and some webinars that we ran with some of our esteem colleagues - including Rob Califf and Harlan Krumholz, and Deb Estrin - just the idea that we have learned a lot as a result of the COVID experience, and we do need to ensure that what we've learned and those things that actually have benefited the clinical trial experience, not only for participants, but potentially for investigators as well, and outcomes more coming more quickly, that we have to ensure that these are not compromised as we move forward. That we don't fall back simply because it's a little easier to fall back and then it might be to fall forward. And that we take advantage of the things that we've learned, especially that technology is now a new enabler for improving the efficiency and quality of clinical trials. When used appropriately, when used in the right context, and when used with tools that actually have the ability to be used for regulatory decision making. You know, we have to ensure that we're not just simply falling back onto technology for technology's sake. We have to ensure that we're using the kinds of tools that actually can be helpful and useful for regulatory decision making.   Janet Kennedy: (22:30) Tell me a little bit about incorporating patient voice through patient reported outcomes and real world evidence. Is that something that is now you would almost consider mandated as part of a clinical trial?   Sally Okun: (22:42) Not so sure we're at mandated yet, but I think we can recognize just how important and valuable real world data is to understanding the real world experiences of real people, right? And yet I think we still have a fair amount of work yet to do on translating that - all of those different types, disparate types of data - into the totality of evidence, within which real world evidence will be one piece of it, that then contributes to a regulator's understanding of the sponsors data. So I think, yes, I think real world data and real world evidence have definitely achieved the validity of being important as part of the clinical trial and clinical research experience. And we're seeing, increasingly, opportunities where that's now starting to become more important to regulators. For example, you know, FDA is continuing to meet its mandate from the 21st Century Cures Act, where it was required to issue guidance on the use of real world data and real world evidence for regulatory decision making.   Sally Okun: (23:42) So they now have I think issued, I wanna say four of the four, but the last one or two are still in draft and will have no final rule yet. But those are important considerations; to think that the regulator themselves has now put forth what they feel will be required for the use of real world data and real world evidence for their ability to make good decisions. Additionally, EMA just recently stated a vision that enabling the use of real world evidence and establishing its value for regulatory decision making is going to be required in Europe by 2025. So these, you know, different entities are putting a stake in the ground and they're saying okay, similar to what we're doing with our vision, right? The idea is that we need to ensure that all the data that could contribute to our understanding of what it takes to have a medicine or device developed so that it can be used to improve outcomes for people needs to come to bear.   Sally Okun: (24:37) And we can't simply just look at it and say, "It's too complicated, or it's too difficult to translate that data into something that's understood by the regulators." We have to figure that out. And I think there's going to be a lot of work in the coming year or two on that very topic. You know, there's a lot of work being done. For example, Duke Margolis has had a point of care working group now for some time that I've actually enjoyed being a part of, and they're aligned very much with our work being done in trials and healthcare settings. So you can see those two things are both totally aligned and related. We're working at it from a different perspective. Duke Margolis, a little more from the policy side and CTTI, a little more from sort of the actual operational side, and bringing those groups together, some of which actually - some of our senior committee members sit on the Duke Margolis's working group too. So there's definitely starting to see this overlap of the attention paid to the value and the importance of this data. So I don't think it'll be long before it becomes something that's just a part of clinical trial experiences. But I think we still have a little ways to go before we actually see it integrated into every clinical trial.   Janet Kennedy: (25:41) Now before we started recording, we talked a Little bit about where and when we'll be able to interact with CTTI in public, and it sounds like you're shooting for a live meeting about a year from now?   Sally Okun: (25:53) The meeting we were talking about in fact was our steering committee meeting. So we have two meetings a year where we gather our executive committee and our steering committee for two days of meetings. One will be in March, which we're going to be doing virtually. And the other will be in September. In the meantime, throughout the course of the year, we actually do a number of webinars and other events that actually are open to the public to learn about some of the work we're doing. And we will definitely continue to do those. Those right now are quarterly, but we might likely start to increase those depending on how the work is going on. Each of the pillars for the transforming trials vision. But the September meeting will be the first time our steering committee and executive committee see each other in person since the pandemic. So we're very excited to shoot towards that. And obviously we'll be flexible and adaptable as needed, but right now we've made that commitment that we will see each other in person in the fall.   Janet Kennedy: (26:44) That is exciting. And I hope we get to meet in person sometime in 2022. The conference season looks like it's kicking back in with protocols in place, but that we're gonna be face to face more than we have been in the last two years. So hopefully I will get a chance to run across you at one of the conferences coming up in the spring.   Sally Okun: (27:05) I would enjoy that very much, Janet. Yes, I've actually just recently had my first foray out into the professional traveling again. And that was a quick trip to Boston and followed by a quick one to D.C. Both of which felt very odd, but also at the same time felt very good. And it was wonderful to see friends and colleagues that I just haven't seen in way too long.   Janet Kennedy: (27:26) It is surprising what good friendships are developed in the professional environment. We talked a lot about family and COVID'S impact on family units. But for many of us, our colleagues are also just as much our family members, and not being around these people who stimulate our minds and get us really interested in new ideas; it really is very draining and disappointing not to be near some of these amazing people.   Sally Okun: (27:55) That's such a good point. I mean, I know I thrive on just having conversations with people face to face and hearing their ideas about what they're doing or giving me some feedback on a presentation I just did. You know, I just always loved the after experience of being a part of a panel or part of a, you know, presentation that was being held at a conference, and just the feedback you would get from people on the things that you talked about is, was just - really provided me with professional learning that I couldn't get anywhere else, frankly.   Janet Kennedy: (28:22) Absolutely. Alright, well, hopefully a cup of coffee in real life is going to be on our agenda sometime in 2022. Well, Sally Okun, executive director for the Clinical Trials Transformation Initiative, thank you so very much for joining me on the People Always, Patients Sometimes podcast.   Sally Okun: (28:40) Janet, it has been my true pleasure to connect with you again, and I look forward to many times of having the opportunity to see you and spend some time again. Thank you so much. And thank you for the highlight for the Clinical Trials Transformation Initiative and our work. We really appreciate it.   Janet Kennedy: (28:55) Absolutely.

Today's episode is all about training. With more young people entering the EMS industry, the need for training is higher than ever before. In this episode we'll talk with IPC training expert Bob Doetzer about the benefits of training. Both training to IPC standards and practical training will be discussed. Bob Doetzer, President of Circuit Technology Training, Inc (or CTTI for short). CTTI offers training in all IPC assembly specifications as well as CTI, Weller, ESD, lean six sigma, SMT Boot Camp and custom courses tailored to their customers' requirements. In addition to ongoing process and IPC support after training, they offer PCB assembly and process engineering support for Air Vac, Juki, Weller, YesTech, and Heller, among others.They have 6 state of the art, dedicated training centers:– Costa Rica– Melbourne, Florida– Baltimore, Maryland– Raleigh, North Carolina – Manassas, Virginia– Rock Hill, South CarolinaBob may be reached here:Bob DoetzerPresident Circuit Technology Training Inc.Phone: (844) 900-2884bob@circuittechnology.com

Spencer Health Solutions has invited Dr. Pamela Tenaerts to join us on the "People Always, Patients Sometimes" podcast to learn more about an important initiative to improve clinical trials. Dr. Tenaerts is the Executive Director of the Clinical Trial Transformation Initiative known as CTTI. Tom Rhoads (00:04): Hi, I'm Tom Rhoads, CEO of Spencer Health Solutions. In an earlier episode of the "People Always, Patients Sometimes" podcast, we heard about the founding of the DiMe Society from Jennifer Goldsack. The organization was created by participating members of CTTI who wanted to continue their work on the impact of digital health on clinical trials. We thought you would like to hear more about CTTI, the Clinical Trials Transformation Initiative, so we invited CTTI's executive director, Dr. Pamela Tenaerts to join us on the podcast. The program is a public-private partnership is shaping how clinical trials are and must evolve to be more efficient and effective. You'll hear how CTTI is living its mission to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. Thanks for listening to the "People Always, Patients Sometimes" podcast. Janet Kennedy (00:54): Spencer Health Solutions has invited Dr. Pamela Tenaerts to join us on the podcast today to have a chance to learn more about an important initiative to improve clinical trials. Dr. Tenaerts is the Executive Director of the Clinical Trial Transformation Initiative known as CTTI. It's a public-private partnership whose mission is to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. My name is Janet Kennedy and I'm your host for the "People Always, Patients Sometimes" podcast, a production of Spencer Health Solutions. I'm really looking forward to my conversation with Pam on the podcast. Welcome to "People Always, Patients Sometimes," Pam. Dr. Pam Tenearts (01:37): Thank you, Janet and I'm looking forward to it as well. Janet Kennedy (01:40): I understand that CTTI has actually been in existence for quite a while and in the digital health space for about eight years or so. Is that correct? Dr. Pam Tenaerts (01:51): Yes. We were actually lucky enough to celebrate our 10 year anniversary in 2018 so we've been in existence a lot. We've started with more general clinical trial improvements and then we are thinking more and more about the trials of the future Janet Kennedy (02:07): What was the initiative for getting it started in the first place? Dr. Pam Tenaerts (02:11): It was really a group that came together at the time. Remember, this is in 2007 is when we officially started and then we kind of developed an executive committee and went from there. But at the time there really wasn't anyone coming together to improve clinical trials and we really were looking at identifying practices that would increase the quality and efficiency of clinical trials. Over time, we have changed our mission to be more action-oriented because we realized that just identifying ways of doing things better doesn't really, it's not helpful enough for most organizations. So now we also drive adoption of the practices by creating more tools and resources that can help with those recommendations that we create. Yeah. At the time, I think we were one of the only organizations in the field, and we've been lucky enough to have other organizations come along as well, such as MRCC and TransCelerate because there's really so much work to be done. You know, it's a good evolution for clinical trials. Janet Kennedy (03:16): I'm curious about the impetus for this though. Did it come from pharma companies? Did it come from academia? Did it come from healthcare itself? Dr. Pam Tenaerts (03:27): Lessons are that it came from conversations between Rob Califf and the food and drug administration people. And they were talking about how things should be better, how things should be improved. And the FDA decided to put some effort into actually doing something rather than just talking about it. When you bring clinical trials, individuals together, we start complaining a lot and talking a lot about how this could be better or how that could be better. But at the time nobody was actually doing anything about it. So it was really sort of a call to action where then the food and drug administration created a memorandum of understanding with this university to set up this consortium. And from the beginning, it was clear that the only way we could get to solutions was involving everyone. So from the beginning we had organizations and individuals from across the enterprise representing academia, clinical investigators, government regulatory agencies, industry institutional review board, also patient advocacy groups. We've had patients in our efforts from the very beginning on our executive committee. We've also identified individual patient representatives that are folded into the steering committee. So we really bring everyone together and that's kind of how it started. It's a little bit of the Greenpeace model. You have to be part of the solution so I have a solution that is sustainable for the enterprise. Janet Kennedy (04:53): You know, I'm fascinated that from the very beginning CTTI committed to having patients a part of the process and that seems to be something that just now is being fully embraced, not necessarily done but embraced by pharma companies and protocol designers and even conferences on clinical trials. What do you think was really pushing the idea that patients needed to be a bigger part of the process 10 years ago? Dr. Pam Tenaerts (05:23): I think it was really the understanding that patients are a part of this is that participants in clinical trials are a part of some people living with diseases that need medical solutions should be part of how you develop them. When we first started, we had one representative on the executive committee, so that is a body direction and sort of work on strategy. We also had patients, individual patients voted into our member organizations, but in 2000 we actually upped that and I think that's even before a lot of these recent activities happened too. In 2013 we did a patient leadership council where we invited individuals from patient organizations, so this is not individuals but people representing groups like coma and things like that and we asked them to be part of CTTI. We had created a separate body for them, patient leadership council, so that's there a year or two Dave really asked us to become part of the membership organization, so now about 20% of our members are patient advocacy groups. Since then also every time we set up a project, we used to have leaders on a project from industry, government and academia as since 2013 patient leaders became part of our context as well. And I have to say it's changed the way we did things for the better. We've learned a lot and I think our recommendations have become even better than they were before. Janet Kennedy (06:59): I'm very interested in the part of your mission that talks about improving clinical trial efficiency, not necessarily efficacy. So what was inefficient about clinical trials that came to your attention? Dr. Pam Tenaerts (07:13): So at that time, CTTI was founded and I think it's still the case. There was his sunset clinical trials were getting more expensive and that maybe who was doing these. That does not add to the quality of data and integrity of data, which is sort of why we came up with our quality by design project as well. But the efficiency part is really addressing the complexity. Clinical trials are too complex and probably should not be as complex as they are to get to a reliable result. At the time, there was a sense that recruitment was slowing, which I think is still the case that recruitment could be better. Investigators were leaving clinical trials because it got too complex. This was also done at a time where the medical community really felt that we could use better evidence to was critical that we came up with a system that could provide this evidence in the most simple way possible to get the most reliable results that can be used for decision making. Janet Kennedy (08:21): And so you mentioned what the result of that was, the quality by design program. Dr. Pam Tenaerts (08:26): So yeah, the very first project was monitoring, this is in 2008 and this was sort of thinking about all the ways people were monitoring and you know, some people monitor, a lot of people at the time monitor a hundred percent some monitored, zero and some did something in between. And we were really trying to understand, you know, why all these things were happening and what the best ways would be to make sure that you have data. Because that is really the goal of monitoring, right? To make sure that you have quality, reliable data on that PCC was maintaining. You're in the conduct of the trial. So what we found is that if we think we can build it in quality at the back end, we're a little bit mistaken, but we really need to think about quality and that is where quality by design and manufacturing, it's really setting up your system so that you have the least errors, to begin with. And so our quality by design is focused on areas that matter and it's sort of really getting us to recruit a call that is as simple every 10 the and not more complex than it should be to get you reliable data in a systematic way. Janet Kennedy (09:45): And as you develop these programs, who are they accessible to are? How do you provide them to the industry? Dr. Pam Tenaerts (09:53): CTTI has a public-private partnership grants in the food and drug administration, which is kind of unusual because they're not a grant creating organization because we get federal funding. We are very keen on making everything accessible to everyone. So wild member organizations and people working on our team might have slightly earlier access. When we launched things like maybe we do an internal webinar before, once we've launched our recommendations, they become available to everyone on our website. So they are available to everyone. If people ask questions, we answered them, we help them. Janet Kennedy (10:33): Well, that's great. So all the things that you're developing, these resources are openly available to companies from your website. Dr. Pam Tenaerts (10:41): Exactly. And we encourage everyone to use them. And we've actually started a use case library to sort of document in a systematic way how people are using our recommendation members or non-members. It's open to everyone because what we've learned is that people really like our recommendations, but if you're trying to do something new, that's always hard. Right? So what we've learned from our members is that, Oh, we really want to use this, but it'd be so nice if we could see how somebody else has used this first. So this library serves two purposes. First, collecting our impact and selecting how people have used our recommendations, but then at the same time it becomes a resource to other organizations who want to adopt our recommendations or part of our recommendations. And we're hoping to create a community that way that can together improve clinical trials after we've launched our recommendation. Janet Kennedy (11:40): Oh, that's excellent. And this is an ongoing initiative. How do you decide what projects you're going to work on or what kind of content or programs you develop every year? Dr. Pam Tenaerts (11:53): Basically three ways in which we identify projects. One that is a partner with Duke University in the, in the partnership, the food and drug administration has an opportunity to ask us to do work. We call those. That's not of biggest part of our projects. The biggest part of our projects comes from members. So once we have the capacity, we go through an exercise with our members where we asked them what are they thinking about in clinical trials, what are their organization trying to solve? And we created a list of items. For example, last time around what came up was massive protocols people started to see across the enterprise and I remember around master protocols, pragmatism and clinical trial diversity. So those were products that our members identified. Once we create that list, that is the benefit of membership. While our resources are available to everyone. The members do get to vote on what we work on. Dr. Pam Tenaerts (13:02): The last way is sort of something that I can recommend that and that might be an opportunity that comes up or something that we think is really worthwhile and then I recommend that none of the projects are actually approved until the executive committee decides that we should move forward with them. We think about approval of projects. We are very careful in talking to ongoing other initiatives to make sure that we're not duplicating work or that we're not doing things that they're already doing. Our project managers create concept sheets that include talking to experts in the field. Like I said, making sure that we're not duplicating efforts and sometimes it's a little confusing because we might have an on the surface, similar names, different aspects of that issue, like informed consent. We have done some work on a chest, had done some work on it, but we're actually doing very good things that we are very careful because again, we use a lot of federal money. You don't want to waste those tax dollars on things that our people are already doing. We also approved projects. They sort of think about the uniqueness of the strategic impact of clinical trials in the future and sort of the dislocation efforts and things like that. Janet Kennedy (14:27): Now who does the actual work? Is this the members are joining committees to get involved or do you actually have staff there? Dr. Pam Tenaerts (14:34): It's a combination of both. We have a staff of project managers who get assigned these projects and they are really responsible for moving everything along and creating the framework for developing the project plan and things like that. But then reached out to our members. Every time a project has been approved by the executive committee, we send out a newsletter to our members and say, you know, just recently it was pragmatism in clinical trials and qualification of novel endpoints using global technology. So we send out an email, we say this is a concept we're going to be working on this, who would like to join? And then our members respond and then we create team leaders and the team leaders also have to come from member organization. So like I said, we kind of take a look at where while we kind of go for the academia-industry, government and patient advocacy, we also try to just look up a project and see what makes sense for government. Dr. Pam Tenaerts (15:34): It's important that both an NIH component and an FDA component, so once we identify the project's meters, now we also create a scene and then we supplement that team. Sometimes people that are not in our membership or people of organizations that like I said are not in our membership and that is needed for that project. When we work on projects and just people that are already getting paid by their organizations, we don't reimburse for participation on projects, but patients, individual patients, we reimburse for participating in our project so that everybody's on the same plane. So we're very careful about making sure that when you're sitting at the table around these projects, everybody has an equal voice and we see that that requires the individuals who might have to take time off from work to sit on project meetings for two hours or come to our meetings as they're working on the project. But then other people, sometimes academics as well because their lives, their life is a little hard VC and so they need to have research time that we reimbursed on their salaries. Janet Kennedy (16:44): I think that's wonderful. I really think that the challenge in having public-private partnerships and having industry leaders as a part of it is honestly for some of them it's easy to be there because their role is funded. It's just something they work into the workload. And the other thing is that it can mean that in many cases they're overly influencing what's happening. You know, I was on a consumer product safety committee and yet it was all made up of the people who manufacture the product. So there was no representation from the consumer at themselves. So it didn't make sense that the people building it. We're actually building our own safety regulations. Dr. Pam Tenaerts (17:26): Interesting. We're actually doing interviews with finished up project teams, so projects that have ended in the last few years. And one of the questions that is really important to us, if I were talking to representation from everyone on this project team, so patients in the streets, government, everyone. And one of the questions we're really sure of that we create that environment is, is your voice heard? Do you see like your boys have equal weight as everyone else's? Because that is I think, critical and moving the field forward. Janet Kennedy (18:01): I love it. Well, tell me about how does somebody actually join if they want to be a part of CTTI. Is this an open organization anyone can join and how does the fee schedule work? Dr. Pam Tenaerts (18:14): More and more talking about how to best engage with CTTI membership is certainly an option but might not be an option or might not be sort of the best path forward for everyone. People typically reach out to us or we have conversations with them to kind of figure out what the best way to participate is on an organization like CTTI. Because for example, some companies might be really interested in one very specific topic of a project that we're working on, but not quite as much on the others. And then so we have other ways that they can engage as part of our projects. We do interviews that we do surveys, we do expert meetings. So for some organizations and people, it makes much more sense to engage that way. Where people and organizations that really work in the fields of medical product development and have the passion to improve clinical trials. Dr. Pam Tenaerts (19:06): This is obviously not a platform where you can sort of access people that you can sell something to. We are very strict on avoiding that kind of a situation because we really do want everybody to feel like they can and they're not going to be sort of approached about clinical trials as a product. We do a little bit of screening from that perspective, but if you're an organization that has is very key interest on improving clinical trials and it is more than just about one particular thing and then a conversation is the first thing and then we can figure something out. Our fee schedule is online and has since 2007 since we started because when we started I talked about the memorandum of understanding the drug administration. So they basically said, we think this is a very good idea for to start this, but we have no money. So at the time the executive committee came up with a fee structure for people to join as members and it ranges from $70,000 for a global organization that has more than $20 billion in sales, to zero if you're an individual patient advocate. Janet Kennedy (20:18): Fabulous. Again, level playing field, you need to have the commitment coming in that matches your ability to pay. Dr. Pam Tenaerts (20:27): Exactly. You know, it doesn't make sense for everyone to be a number either because one, once you remember, we want to make sure that that's a value proposition for you, that you get something out of it that is not something that you do but you get something out of it that your people in the organization get something out of it and you can contribute. Now having said that, we don't need people that are complete experts, sort of, you know, key opinion leaders. We also want people with boots on the ground. So a lot of our projects include coordinators because you know the PII is one thing. A coordinator on the ground has a very different perspective of how in their day to day life. Janet Kennedy (21:10): That makes so much sense because that's where the efficiency falls apart. Someone can have a grand idea for a project, but if they're not the one implementing and saying, Hey, these two things aren't matching up and they're not working, then they're not getting the kind of information they need to make changes. Dr. Pam Tenaerts (21:26): Exactly. Janet Kennedy (21:28): Well, what about the longer-term vision for CTTI? Where do you hope to be in 10 years? Dr. Pam Tenaerts (21:34): Interesting that you ask that. We're actually working on a vision, we call it vision 2030 and really thinking about what clinical trial should look like 10 years from now with the idea that it should be achievable, but it should be a little bit of a stretch. So we're thinking about what they should look like and then also what we need to do to achieve that vision. Once we are finished with that exercise and we're hoping to have this done last spring, this here and we'll communicate about this of course, and then we want to ensure it's sort of a guidepost for our project activities at that point. We want to make sure that we work on projects that move the clinical trials ecosystem towards that vision. We're also hoping that our vision aligns with other people's religions, so there will be some work and figure that out. Janet Kennedy (22:24): Awesome. You know, one of the organizations that I have recently joined is the DiMe Society, the digital medicines society, and I understand that that came into existence because it's really an extension of a CTTI project. Dr. Pam Tenaerts (22:39): I'm not sure I would characterize it that way, but Jen Goldsack, who was the project manager on our novel digital and mobile technologies ended up becoming the executive director for DiMe, so I'd like to think it has something to do with school lessons of different things that were going on in the world. Right. There's a lot of movement around mobile clinical trials and technology and clinical trials and there wasn't really his feet for what are really two very different industries. If you think about a technology and medicine to come together and they've provided a forum to create that and yes, I think it's very worthwhile. I'm on the scientific leadership board. Janet Kennedy (23:26): Well, I will tell you the Jen gives CTTI a whole lot of credit. When we did a podcast interview discussing the dimes society and they basically said they got inspiration from working on CTTI projects and felt that they wanted to continue after. You'll be proud to know that there are over 800 members in the organization now. Dr. Pam Tenaerts (23:46): You know Jen and I, we used to work together but we still see each other a lot. We actually had to live in the same town and Florida, so now we do yoga together. Janet Kennedy (23:57): How often do you make it up to Duke? Dr. Pam Tenaerts (23:59): We are the distributed team, so about half of the team are remote and we are sort of dispersed from as far as Seattle to Sarasota, Florida and then everything in between. So we're kind of dispersed. We go every month or two days to sort of coalesce the team and bring all of us together. Obviously a lot of our work is on the phone. I have to credit Andy Coravos for doing more of our work on video conferences. We used to never do videos. I'm starting to like it a little bit better when you talk. So internally we do a lot more video conferencing. We do a lot of work on the phone. Obviously your work on a project is on the phone. We do have sort of, uh, opportunities to bring teams together, especially in the beginning so that we can make sure they call a left swell because people have to get used to each other. You know, understanding, learn who is voices and those kinds of things that we come together for two days, once a month. Janet Kennedy (25:04): Oh, that's excellent. Well, maybe next time you're in town I will get a chance to meet you in person. Dr. Pam Tenaerts (25:09): Oh, are you in Durham? Janet Kennedy (25:10): Oh, well I'm in Raleigh. Dr. Pam Tenaerts (25:11): Oh yeah, of course. Absolutely. Janet Kennedy (25:15): One thing I didn't ask you is about your background and how you came to CTTI in the first place. Do you mind telling me a little bit about your history? Dr. Pam Tenaerts (25:24): So I was trained as a general practitioner in Belgium and after a couple of years of doing that, I started working at the university and there's a funny story about that because the day of my interview with the professor of cardiology, I started in cardiology clinical trials. I worked on the Gusto study, which I thought every study was like this. Every clinical trial that had 42,000 patients. That's how I got into clinical trials. But the day of my interview, the professor asked me if I wanted to have dinner with the American. He first said, do you want to have dinner at the faculty club where I went to medical school and as a student, typically you don't have access to the faculty club at all. Dr. Pam Tenaerts (26:12): And then it turns out to be with the Duke folks and Rob Califf that day. The first day I interviewed for a clinical trial job. And so Rob is a constant for many people in the clinical trials world. After I finished the two-year appointment I had in Belgium, I came over to the West to work on the American side of clinical trials in the coordinating setting and that's really how it got started. A couple of years later I left and in 2012 I started having conversations again and then back up at CTTI, which is sign of a nice culmination of different experiences I've had working at a large university in Europe leading the European center for a multicenter, huge clinical trial, going to pharma, going to Duke at the time, then to a community hospital where I ran a research center. Then I went back to a device company to run the European operations and then to Duke. So it was a nice combination of being able to provide solutions to all of the issues I had encountered over what was by then about a 20-year experience in clinical trials. Janet Kennedy (27:24): Thanks for listening to this episode of "People always, Patients Sometimes" with our guests. Dr Pamela Tenaerts, the Executive Director of the Clinical Trial Transformation Initiative. Thanks for joining us, Pam. Dr. Pam Tenaerts (27:36): It was a pleasure. Thank you very much, Janet.

Happy Independence Day, everyone! Today's guest is the Executive Director of a brand new society, The Digital Medicine Society! Jennifer Goldsack, MChem, MA, MBA, OLY Bio: Jen Goldsack is VP of Digital Measurement at monARC Bionetworks and serves as the Interim Executive Director of the Digital Medicine Society (DiMe). Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI) where she led development and implementation several projects within CTTI’s Mobile Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System. Jen spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Jen earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian and World Championship silver medalist. DiMe's bio: Founded in 2019, the Digital Medicine Society (DiMe) is the professional organization for experts from all disciplines comprising the diverse field of digital medicine. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health. Website: https://www.dimesociety.org/ LinkedIn: https://www.linkedin.com/company/dime-society/ Blog: https://medium.com/digital-medicine-society-dime/laying-the-foundation-defining-digital-medicine-49ab7b6ab6ef

This podcast features a panel previously recorded at the 5th annual Patients as Partners US program on Engaging Patients By Giving Them their Data. The panel, moderated by David Leventhal, Director of Clinical Innovation for Pfizer, discussed: • What information and data do patients want during a clinical trial? • What initiatives is pharma currently doing to support this? • What impact will it have if patients have access to their data? Additional panelists included: Jenny Ahlstrom, Myeloma survivor and Co-founder, CrowdCare Foundation Kristina Figueroa, MSPH, Patient and Advocate Cindy Geoghegan, Cancer Survivor, Patient Advocate & Team Lead, CTTI’s Mobile Clinical Trials Stakeholder Perceptions Project Thérèse Johnsen, Associate Director, Patient Engagement Management, Novartis Join us for the 6th annual Patients as Partners US program on March 11-12 at the Wyndham Philadelphia Historic District Hotel in Philadelphia where we feature extended sessions on The Democratization of Patient Data & Returning Data to Patients.Patients as Partners US is the only conference that demonstrates how to involve patients throughout the entire medicines development life cycle to drive greater efficiencies in clinical research.For more information visit www.theconferenceforum.org. 

Les Jordan, Working Group Member and Cindy Geoghegan, Team Lead for CTTI, the Clinical Trials Transformation Initiative, share findings from a multi-stakeholder project undertaken by the Clinical Trials Transformation Initiative to better understand patient perspectives on mobile technologies in clinical trials. The survey, conducted amongst 100 patients across multiple therapeutic areas, evaluated the ways patients would be willing to use mobile technologies and the impact on their participation in clinical trials. Additional focus areas included: • Potential impacts of mobile on participant experiences in clinical trials • Patient willingness to share personal health data • Important attributes for designing trials that address patient preferences and expectations • Implications for the research enterprise CTTI will also be joining the 6th annual Patients as Partners US program on March 11-12 at the Wyndham Philadelphia Historic District Hotel in Philadelphia where they will share newly-released recommendations and actionable tools, understand unique considerations for participants in mobile trials, and opportunities to effectively engage patients during trial planning. For more information on the 6th annual event, visit www.theconferenceforum.org. 

This week we welcome Dr. Robert Califf to our season finale of Trial by Data to discuss CTTI, his role in Project Baseline, and his thoughts on Watson. . . . Trial by Data, presented by Litmus Health, is a podcast exploring the data-driven technologies and strategies shaping the future of clinical trials. We cover the most pressing issues and questions facing researchers and clinicians today, in an ever-changing landscape. Listen in as we interview leaders and innovators in the field who are at the forefront of developing and using these data-driven approaches.

Founded in 2007 by the FDA and Duke University, the Clinical Trials Transformation Initiative (CTTI) has as its mission to develop and drive the adoption of practices that will increase the quality and efficiency of clinical trials. Pamela Tenaerts, CTTI's Executive Director, has a broad international perspective given her previous life running large international clinical research at KU Leuven, and we were fortunate to catch up with her at the IMI Stakeholder Workshop in Brussels to discuss how to improve clinical research.

Mobile Podcast Series #2 CTTI Findings are in from their Mobile Clinical Trials Program: Recommendations on Novel Endpoints CTTI's Mobile in Clinical Trials program was launched three years ago to propose recommendations that clarify the pathway for developing novel endpoints for use in clinical trials from data generated using mobile technology. Jennifer Goldsack shares recommendations and insights from their findings on: Developing an internal process for identifying endpointsStrategies for reducing friction throughout the processExecuting the processThe science required to validate an endpointA suite of tools developed in the process to help facilitate implementation The next Mobile in Clinical Trials conference is September 24 in Boston. Mobile is the annual update on not only the latest progress in applying mobile/digital tools to clinical trials, but how and when to do this and for what benefit.  Speaker: Jennifer Goldsack, MChem, MA, MBA, CPHQ, Clinical Project Manager, CTTI Producer: Valerie Bowling, Executive Director, Mobile in Clinical Trials

Pan American Games Champion, Olympian and World Championship silver medalist, Jennifer Goldsack, became a world-class athlete while working and studying at the University of Oxford. How did she do it? She recently shared her story with DPharm Director, Valerie Bowling, discussing the lessons she learned from her Olympic experience and how she uses them in her professional life at the Clinical Trials Transformation Initiative (CTTI). Ms Goldsack manages the development and implementation of Clinical Trials Transformation Initiative (CTTI) projects. In collaboration with team leaders, she creates project plans and budgets, and manages the implementation of those plans. She earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality.  Ms Goldsack spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, Ms Goldsack helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware.  Ms Goldsack recently presented at the Mobile in Clinical Trials conference organized by the Conference Forum. For more information, visit: www.theconferenceforum.org.