POPULARITY
10 episodes with trial design
4 episodes with trial design
5 episodes with trial design
2 episodes with trial design
2 episodes with trial design
2 episodes with trial design
2 episodes with trial design
2 episodes with trial design
2 episodes with trial design
Is minimally invasive ablation the future of metastatic cancer care? We now have the results of the COLLISION Trial, which investigates the non-inferiority of thermal ablation compared to surgical resection. How will these findings change treatment paradigms and practice patterns around metastatic colorectal cancer? In this week's episode of BackTable, interventional radiologist Dr. Chris Beck discusses the impact and implications of the COLLISION Trial with principal investigator Dr. Martijn Meijerink from Amsterdam UMC.---SYNPOSISThe doctors explore the COLLISION Trial's design, results, complication rates, and future directions. They also cover best practices for ablation techniques and the potential for interventional oncology to enter a “golden era.” Finally, Dr. Meijerink highlights the importance of standardizing intervention quality and being present in tumor boards to ensure optimal patient care.---TIMESTAMPS00:00 - Introduction 03:21 - Understanding Metastatic Colorectal Cancer and IR's Role05:18 - Introduction to the COLLISION Trial07:40 - Radiofrequency vs Microwave Ablation and Technological Advancements09:02 - Trial Design and Patient Eligibility16:20 - Ablation Techniques and Approaches22:05 - Trial Results and Analysis30:19 - Impact on Guidelines and Practice39:44 - Best Practices in Thermal Ablation43:27 - Future Directions in Interventional Oncology---RESOURCES“Surgery versus thermal ablation for small-size colorectal liver metastases (COLLISION): An international, multicenter, phase III randomized controlled trial.” (Meijerink, 2024)https://ascopubs.org/doi/10.1200/JCO.2024.42.17_suppl.LBA3501
Send us a textWelcome to The Oncology Journal Club Podcast Series 3Hosted by Professor Craig Underhill, Dr Kate Clarke & Professor Christopher Jackson | Proudly produced by The Oncology NetworkThe Oncology Journal Club team take a deep dive into three standout papers:Craig kicks us off with a timely perspective on the long-term toxicity of immune checkpoint inhibitors—are we ready to widen the lens? He highlights the need for more comprehensive research on survivorship issues including quality of life, financial impact and psychological outcomes.Kate brings us the exciting results from the INFINITY study on gastric and gastroesophageal cancers which shows impressive complete response rates in dMMR gastric cancers but at prohibitive costs — and poses a big question: are we ready to rethink treatment paradigms?And CJ unpacks the Common Sense Oncology principles for designing better phase 3 trials — Common Sense Oncology principles offer a patient-centred framework for designing and reporting clinical trials.Of course, we've also got our Quick Bites—those quirky, surprising papers that made us raise an eyebrow or two. From RNA vaccines in pancreatic cancer to updated ASCO guidelines for small cell lung cancer, it's a rapid-fire segment you won't want to miss.For links to the papers discussed and bios of our hosts, head to the show notes on oncologynetwork.com.au.Subscribe to The Oncology Newsletter for regular updates on the latest cancer research and join our community at oncologynetwork.com.au.The Oncology Podcast - An Australian Oncology Perspective
ACRO's Good Clinical Podcast is back for season 3! To kick off the season, host Sophia McLeod is joined by Clare Campbell-Cooper (Global Head, Digital Health and Innovation, Fortrea) and Michael J. Cohen (Sr. Director, Lead, Environmental Sustainability, PPD™ clinical research business of Thermo Fisher Scientific) to discuss the continued evolution of environmental sustainability in clinical research. They dive deeper into how the clinical research industry can use renewable energy to help meet environmental goals, the importance of promoting more environmentally sustainable shipping and logistics practices, and how our industry can decentralize trial elements responsibly to minimize the environmental impact of the clinical supply chain.
In this episode of Joint Action, Professor David Hunter is joined by Dr. Bruno da Costa, Associate Professor of Clinical Epidemiology at the University of Toronto and Senior Scientist at the University of Oxford, to unpack the evidence behind injections for osteoarthritis.Dr. da Costa shares insights from his recent systematic review and network meta-analysis of clinical trials, revealing just how limited - and at times unreliable - the evidence is for many joint injection therapies.This episode explores:Which injections (if any) offer real benefit - and for how longThe surprising extent of bias in osteoarthritis trialsWhy some results may not be as credible as they seemThe role of placebo effects and commercial influenceWhat this means for people living with osteoarthritisIf you've ever considered injection therapy, this episode will help you sort fact from fiction.RESOURCESS04E10 - Care for an oil change? The role of viscosupplementation for osteoarthritis wit Dr Bruno da Costa: https://www.jointaction.info/podcast/episode/6cda642b/care-for-an-oil-change-the-role-of-viscosupplementation-for-osteoarthritis-with-dr-bruno-da-costaInfographic - How effective are intra-articular interventions for osteoarthritis?: https://www.osteoarthritisresearch.com.au/s/0225-Clinical-Editors-Choice.pngArticle - Effectiveness and safety of intra-articular interventions for knee and hip osteoarthritis based on large randomized trials: A systematic review and network meta-analysis: https://www.oarsijournal.com/article/S1063-4584(24)01389-X/fulltextCONNECT WITH USTwitter: @ProfDavidHunter @jointactionorgInstagram: @osteoarthritisresearchgroupEmail: osteoarthritis.research@sydney.edu.auWebsite: www.jointaction.info/podcast Hosted on Acast. See acast.com/privacy for more information.
Interview with Ruth J. Davis, MD, author of Third Proceedings of The North American Airway Collaborative (NoAAC): Consensus Statement on Trial Design for Airway Stenosis. Hosted by Paul C. Bryson, MD, MBA. Related Content: Third Proceedings of The North American Airway Collaborative (NoAAC)
Interview with Ruth J. Davis, MD, author of Third Proceedings of The North American Airway Collaborative (NoAAC): Consensus Statement on Trial Design for Airway Stenosis. Hosted by Paul C. Bryson, MD, MBA. Related Content: Third Proceedings of The North American Airway Collaborative (NoAAC)
What evidence is currently available regarding the use of genicular artery embolization (GAE) for treating knee osteoarthritis? Principal investigator Dr. Mark Little discusses the GENESIS 2 trial, a large randomized controlled study aimed at assessing the outcomes of embolizing abnormal genicular arteries to reduce pain in patients with mild to moderate knee osteoarthritis. Dr. Little explains the trial's design, methodology, and the significance of key data points such as the Knee Injury and Osteoarthritis Outcome Score (KOOS), cost-effectiveness, and quality of life measures. He also covers the materials and techniques used in both the GENESIS 1 and 2 trials, the neuropsychological tests integrated into the study, and potential geographic and anatomical challenges encountered during GAE. Dr. Little highlights the importance of high-quality research and data to support the procedure's efficacy and safety. TIMESTAMPS 00:00 - Overview of GENESIS 2 Trial 04:42 - Embolic Materials and Techniques 09:10 - Challenges in Patient Anatomy & Comorbidities 12:40 - Final Thoughts CHECK OUT THE FULL EPISODE Exploring GAE: Clinical Insights & Outcomes with Dr. Mark Little https://www.backtable.com/shows/msk/podcasts/50/exploring-gae-clinical-insights-outcomes
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Dr Zachary Zumsteg (Cedars-Sinai Medical Center, Los Angeles, CA, USA) discusses his Review on the challenges and opportunities for early phase clinical trials of novel drug-radiotherapy combinations.Tell us what you thought about this episodeContinue this conversation on social!Follow us today at...https://twitter.com/thelancet & https://Twitter.com/TheLancetOncolhttps://instagram.com/thelancetgrouphttps://facebook.com/thelancetmedicaljournalhttps://linkedIn.com/company/the-lancethttps://youtube.com/thelancettv
Phase 3 clinical trials are the most expensive part of drug development, and the most important hurdle to regulatory approval. More than 95% of phase 3 trials in Alzheimer's disease fail. The main reason is a poor foundation, namely, inadequate or misleading phase 2 trials. Dr. Donald Berry, Founder of Berry Consultants and Founder and Professor of the Department of Biostatistics at the University of Texas MD Anderson Cancer Center, along with his son Dr. Scott Berry, President of Berry Consultants, are committed to turning the tide. Their revolutionary methodology involves adaptive clinical trial design within a Bayesian statistical approach.
Phase 3 clinical trials are the most expensive part of drug development, and the most important hurdle to regulatory approval. More than 95% of phase 3 trials in Alzheimer's disease fail. The main reason is a poor foundation, namely, inadequate or misleading phase 2 trials. Dr. Donald Berry, Founder of Berry Consultants and Founder and Professor of the Department of Biostatistics at the University of Texas MD Anderson Cancer Center, along with his son Dr. Scott Berry, President of Berry Consultants, are committed to turning the tide. Their revolutionary methodology involves adaptive clinical trial design within a Bayesian statistical approach.
PodChatLive 142: HCPC social media guidance, Pickleball injuries, and N-of-1 trial design Contact us: getinvolved@podchatlive.com Links from todays episode: Guidance on the use of social media Podiatrists who perform surgery Emerging Patterns of Foot and Ankle Injuries in Pickleball Players Effect of Advanced Footwear Technology Spikes on Sprint Acceleration
Dr. Oren Cohen, President of Clinical Pharmacology and Chief Medical Officer at Fortrea, a global CRO spun-off from Labcorp, discusses the contract research environment and how it continues to change to meet the need for increased productivity in the development and testing of new drugs, devices, and treatments. One key goal is to work in close partnership with clients to include the patient's voice in trial design to increase diversity, drive recruitment, and improve retention. Oren explains, "I think with all the pressure the industry is under productivity pressure, that's changed massively. It's a very heavy responsibility because we are entrusted with developing very precious intellectual property that represents the next generation of therapeutics for patients affected by all the diseases out there, from rare diseases to cancer to neurodegenerative diseases like Alzheimer's. It's a very exciting time. I think the science is moving very quickly, and we have the good fortune to be working on some very promising and super interesting potential products." "There's lots of innovation in every aspect of clinical trials, from design through process and execution to analysis. So yes, all that is on the table. I would say that our preferred method of engagement is to partner with our clients to get to the best place in terms of what advances science. What is necessary from a regulatory perspective to push a product along toward approval, to show its mettle? What is best for patients and sites responsible for recruiting them?" "It's a natural marriage because our sponsors, the biopharmaceutical companies we serve, obviously have the best expertise for the particular molecule they're studying. They've potentially discovered it, they have it in their portfolio, and they obviously know a lot about it." #Fortrea #ClinicalTrials #DrugDevelopment #PatientVoice #ClinicalTrialDesign #CRO #ContractResearchOrganization fortrea.com Download the transcript here
Dr. Oren Cohen, President of Clinical Pharmacology and Chief Medical Officer at Fortrea, a global CRO spun-off from Labcorp, discusses the contract research environment and how it continues to change to meet the need for increased productivity in the development and testing of new drugs, devices, and treatments. One key goal is to work in close partnership with clients to include the patient's voice in trial design to increase diversity, drive recruitment, and improve retention. Oren explains, "I think with all the pressure the industry is under productivity pressure, that's changed massively. It's a very heavy responsibility because we are entrusted with developing very precious intellectual property that represents the next generation of therapeutics for patients affected by all the diseases out there, from rare diseases to cancer to neurodegenerative diseases like Alzheimer's. It's a very exciting time. I think the science is moving very quickly, and we have the good fortune to be working on some very promising and super interesting potential products." "There's lots of innovation in every aspect of clinical trials, from design through process and execution to analysis. So yes, all that is on the table. I would say that our preferred method of engagement is to partner with our clients to get to the best place in terms of what advances science. What is necessary from a regulatory perspective to push a product along toward approval, to show its mettle? What is best for patients and sites responsible for recruiting them?" "It's a natural marriage because our sponsors, the biopharmaceutical companies we serve, obviously have the best expertise for the particular molecule they're studying. They've potentially discovered it, they have it in their portfolio, and they obviously know a lot about it." #Fortrea #ClinicalTrials #DrugDevelopment #PatientVoice #ClinicalTrialDesign #CRO #ContractResearchOrganization fortrea.com Listen to the podcast here
Pink Sheet reporter and editors discuss the US FDA drug approval decisions that could arrive in August (:34), a trial design issue that could ensnare BMS' Opdivo along with AstraZeneca's Imfinzi (10:11), and the EMA potentially asking all sponsors to provide raw clinical data as part of application reviews (33:14). More On These Topics From The Pink Sheet Dozen Novel Agents Dream Of August US FDA Approval: https://pink.citeline.com/PS155070/Dozen-Novel-Agents-Dream-Of-August-US-FDA-Approval BMS's Opdivo May Be Next Casualty Of US FDA's Perioperative Trial Redesign Push: https://pink.citeline.com/PS155056/BMSs-Opdivo-May-Be-Next-Casualty-Of-US-FDAs-Perioperative-Trial-Redesign-Push EU Pilot On Raw Data Analysis Shows Benefits For Streamlining Medicines Evaluation: https://pink.citeline.com/PS155059/EU-Pilot-On-Raw-Data-Analysis-Shows-Benefits-For-Streamlining-Medicines-Evaluation
FDA appears to change its stance on evaluating perioperative (adjuvant followed by neoadjuvant) ICI study designs in NSCLC. Also, a simple blood test is approved to detect colorectal cancer, but there are several limitations compared to colonoscopy.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.*
ACRO's Good Clinical Podcast is back! This week, Stacy Hurt, Chief Patient Officer at Parexel, and Alicia Staley, Vice President, Patient Engagement at Medidata joined the podcast to discuss how we can turn patient centricity from “buzz words” to action. They discuss how their own experiences as patients have informed their approach to clinical research and the important role that an upstream patient voice plays in reducing the burden on patients.
*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ✏️
BioSpace's Lori Ellis and Chantal Dresner are bringing live updates from #DIA2024 in San Diego this week where we've been attending sessions on trial design, digital twins, cell and gene therapy regulation, clinical research workforce trends, professional development and many more. We discuss some of our key takeaways and event highlights, including Lori's exclusive interview with CBER director Dr. Peter Marks. Hosts Lori Ellis, Head of Insights, BioSpace Chantal Dresner, VP of Marketing, BioSpace
In this episode, we review the high-yield topic of Clinical Trial Design from the Basic Science section. Follow Orthobullets on Social Media: Facebook Instagram Twitter LinkedIn YouTube --- Send in a voice message: https://podcasters.spotify.com/pod/show/orthobullets/message
Welcome back to another episode of Real Time Real Talk where this week, host Cher Pastore is joined by Dr Jessica Castle and Dr Stayce Beck to discuss the meticulous process behind the formulation and execution of Continuous Glucose Monitoring (CGM) accuracy trials. The trio discuss the influence of rigorous trial design and transparency on the accuracy and reliability of CGM devices, particularly those developed by Dexcom. They highlight the importance of CGM research's credibility, strategies to minimize bias, and the essential role that regulatory bodies play in ensuring quality health research. The discussion also covers the dynamics of conflicts of interest, patient and healthcare provider education, and the significance of detailed metrics for evaluating CGM performance. Our expert panel also take us behind the scenes to reveal the meticulous work involved in creating and executing CGM studies that encompass different populations and conditions. You'll hear discussions around key performance metrics in a CGM accuracy study, understanding why blood glucose monitor and CGM readings might not match and the explanation of relative difference and CGM accuracy. The conversation highlights the comprehensive journey towards ensuring users can trust their CGM readings, right from day one to real-world applications. Finally, listen as they walk us through the process of bringing transparency to CGM data analysis, alongside discussing the potential challenges and future of CGM device application in pediatric hospital discharge programs, probing into the potential barriers and challenges faced by healthcare providers and patients. Disclaimer: This podcast is not approved for CME credit. Every diabetes treatment plan is different, individual results may vary – nothing you hear on this podcast should be considered medical advice. All claims are supported by clinical evidence referenced in the show notes. For clinical study results, please refer to the Dexcom G7 User Guide. For product-related questions, please refer to the instructions for use. For complete safety information, go to dexcom.com/safety-information. Fingersticks required for diabetes treatment decisions if symptoms or expectations do not match readings. Jessica R. Castle, MD and Stayce E. Beck, PhD, MPH, are employees of Dexcom. Brief Safety Statement BRIEF SAFETY STATEMENT: Failure to use the Dexcom Continuous Glucose Monitoring System and its components according to the instructions for use provided with your device and available at https://www.dexcom.com/safety-information and to properly consider all indications, contraindications, warnings, precautions, and cautions in those instructions for use may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from the Dexcom CGM do not match symptoms, use a blood glucose meter to make diabetes treatment decisions. Seek medical advice and attention when appropriate, including for any medical emergency. Dexcom, Dexcom Follow, Dexcom Clarity, and Dexcom Share are registered trademarks of Dexcom, Inc. in the U.S., and may be registered in other countries. References: 1. Castle JR, Beck SE. The Importance of Trial Design in Evaluating the Performance of Continuous Glucose Monitoring Systems: Details Matter. Journal of Diabetes Science and Technology. 2024 Feb 23 2. Clinical and Laboratory Standards Institute (CLSI). Performance Metrics for Continuous Interstitial Glucose Monitoring (CLSI Guideline POCT05). 2nd ed. Wayne, PA: CLSI; 2020. 3. Garg SK, Kipnes M, Castorino K, et al. Accuracy and safety of Dexcom G7 continuous glucose monitoring in adults with diabetes. Diabetes Technol Ther. 2022;24(6):373-380. 4. Laffel LM, Bailey TS, Christiansen MP, et al. Accuracy of a seventh-generation continuous glucose monitoring system in children and adolescents with type 1 diabetes. J Diabetes Sci Technol. 2023;17(4):962-967. 5. Polsky S, Valent AM, Isganaitis E, Castorino K, O'Malley G, Beck SE, Gao P, Laffel LM, Brown FM, Levy CJ. Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes technology & therapeutics. 2024 May 1;26(5):307-12. 6. Freckmann G, Eichenlaub M, Waldenmaier D, et al. Clinical performance evaluation of continuous glucose monitoring systems: a scoping review and recommendations for reporting. J Diabetes Sci Technol. 2023:17(6):1506-1526.
Joined by MD Anderson Cancer Center clinician and scientist Dr. Pavlos Msaouel, Dr. Aly-Khan Lalani and Dr. Christopher Wallis discuss trial design and statistics in oncology. What are the nuances to reading KM curves? How useful are forest plots? Our guest and hosts dive into this and more in Episode 8. The View on GU with Lalani & Wallis integrates key clinical data from major conferences and high impact publications, sharing meaningful take home messages for practicing clinicians in the field of genitourinary (GU) cancers. Learn more about The View on GU: https://theviewongu.com This podcast has been made possible through financial support by AstraZeneca, Bristol Myers Squibb, Merck, and TerSera.
In this episode of Don't Miss a Beat, Javed Butler, MD, joins hosts Muthiah Vaduganthan, MD, MPH, and Steve Greene, MD, for a breakdown of the EMPACT-MI trial, including primary results, secondary findings, how data from DAPA-MI and EMPACT-MI complement each other, and what is next for the SGLT2 inhibitor class. Key Highlights: 00:00 - Intro 01:57 - Trial Design and Results 07:00 - Inclusion Criteria and Patient Characteristics 10:53 - Primary Results of EMPACT-MI 14:34 - Subgroup Analyses 15:27 - Implications for Post-MI Patient Population 19:53 - Takehome Messages for Care 23:39 - Kidney Outcomes in Post-MI Patient Population
Unlock the secrets of clinical trial design with industry experts Pierre Colin and Boaz Adler as they join us for a deep dive into the early-stage planning that shapes the future of pharmaceuticals. They provide a look at the collaboration between clinicians, statisticians, and regulatory experts that's critical for determining the right patient populations, dosages, and study endpoints. With their guidance, we explore how statistical software and scenario planning play pivotal roles in estimating patient numbers, study durations, and costs, transforming clinical trial design into a fine art.As we navigate through the evolution of statistical methods, our guests share their insights on the need for adaptability in clinical trial designs, especially in areas like oncology with unique endpoints such as overall survival. They spotlight the importance of cross-company collaborations and direct FDA discussions in driving innovations. The conversation also illuminates the ever-growing contributions of R-coding, a testament to the individuality of each study, allowing for customized and cutting-edge approaches to trial design.To wrap up, we spotlight the dynamic landscape of drug development where biostatistics paves the way for groundbreaking designs. Our guests emphasize how feedback from scientific communities influences new methodologies, shifting the focus from traditional success measures to concepts like assurance and power in the promising zone. They also highlight the invaluable role of Bayesian designs, as exemplified by COVID-19 vaccine trials, in ethically accelerating drug development. As we close, remember that this field is ripe with diverse opportunities, and we invite you to reach out with your curiosities and follow-up questions. Join us for this episode that's not just about the science of trials, but the transformation they undergo, ensuring the journey of drug development continues to revolutionize patient care.Guests:Pierre Colin: https://www.linkedin.com/in/pierre-colin-11139028/Boaz Adler: https://www.linkedin.com/in/boazadler/________Reach out to Sam Parnell and Ivanna RosendalJoin the conversation on our LinkedIn page
The Real Truth About Health Free 17 Day Live Online Conference Podcast
Dr Gibson and Dr Nero discuss the oft maligned issue of medical statistics. Their discussion covers the pros and cons of traditional Cox proportional hazards regression models and Kaplan-Meier curves and newer techniques including win ratios. They then dip their toes into AI. A great overview by one of our leading clinical trialists.
The drug development pipeline is key to bringing new therapies to people with Parkinson's disease (PD). With major breakthroughs in research in the past year, including a new biomarker for PD, The Michael J. Fox Foundation's Parkinson's Progression Markers Initiative (PPMI) study and other initiatives can be leveraged to create better designed trials. This audio from our Third Thursdays Webinar features a conversation about all the ways clinical trial design is changing, and why leaders in the space believe those changes will lead to better treatments. The webinar includes contributions from a person with PD, a researcher and an industry leader. Like our podcasts? Please consider leaving a rating or review and sharing the series with your network. https://apple.co/3p02Jw0 Whether you have Parkinson's or not, you can help move research forward. Join the study that's changing everything. Find out more at michaeljfox.org/podcast-ppmi.
Drs. Joseph Sassine and Shmuel Shoham discuss clinical trials for respiratory viral infections in immunocompromised patients, CMV prevention options, and medical education in different places around the world.
Dr. Mohleen Kang chats with Dr. Aparna Swaminathan and Dr. Timothy Dempsey about their articles, "External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources” and “The Added Power of Synthetic Control Groups: Challenging Conventional Wisdom and Trial Design in Idiopathic Pulmonary Fibrosis Research.”
This week we speak to Boaz Adler from Cytel's Software Division. This episode promises to illuminate the intricacies of trial design through the lens of Monte Carlo simulation, revealing how this potent approach crafts trials resilient to a myriad of scenarios. Boaz delves into the pivotal roles of interim monitoring and strategic market positioning post-trial, offering a masterclass in the art of clinical trial conception that withstands the test of uncertainty.As we navigate the vast landscape of clinical trial simulation, the topic of scale takes center stage. The conversation orbits around pioneering software platforms like Solara and East, which are reshaping trial design by integrating a kaleidoscope of variables and uncertainties. This episode pulls back the curtain on the potential of cloud computing to revolutionize simulations, providing a glimpse into the future where clinical trials are executed with unparalleled speed and precision. With Boaz' expertise, we ponder the industry's readiness to trust probabilistic outcomes and how regulatory bodies are warming up to the simulation-based approaches that these software platforms enable.Finally, we bridge the gap between biostatistics and market access, highlighting the increasing influence of health outcomes research on clinical trial design. The discourse delves into the balancing act of incorporating quality of life measures for regulatory and reimbursement decisions, the finesse required to blend standard software with bespoke coding, and the imperative of enhanced inter-departmental synergy. My own path to life sciences underscores the episode's reflective tone, leading to a broader examination of Cytel's extensive contributions to the field, from their roots in Monte Carlo simulation software to a comprehensive suite of services that spans the full spectrum of statistical programming and evidence-based research. Join us for this enlightening episode to gain an insider's perspective on the dynamic confluence of biostatistics and pharmaceutical innovation.Guest: Boaz Adler________Reach out to Sam Parnell and Ivanna RosendalJoin the conversation on our LinkedIn page
Commentary by Dr. Valentin Fuster
Commentary by Dr. Valentin Fuster
In this episode of CUBIST, Amanda and Don discuss the article, "Risk Factors for high symptom burden three months after traumatic brain injury and implications for clinical trial design: A TRACK-TBI study” by Nancy Temkin and colleagues, published in the Journal of Neurotrauma in June of 2022. Article Citation: Temkin, N., Machamer, J., Dikmen, S., Nelson, L. D., Barber, J., Hwang, P. H., Boase, K., Stein, M. B., Sun, X., Giacino, J., McCrea, M. A., Taylor, S. R., Jain, S., Manley, G., & TRACK-TBI Investigators (2022). Risk Factors for High Symptom Burden Three Months after Traumatic Brain Injury and Implications for Clinical Trial Design: A Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study. Journal of Neurotrauma, 39(21-22), 1524–1532. Article LINK: https://pubmed.ncbi.nlm.nih.gov/35754333/ CUBIST is a podcast for healthcare providers produced by the Traumatic Brain Injury Center of Excellence. We discuss the latest research on traumatic brain injury (TBI) most relevant to patient care. For more about TBI, including clinical tools, go to www.health.mil/TBICoE or email us at dha.TBICoEinfo@health.mil. The views, opinions, and/or findings in this podcast are those of the host and subject matter experts. They should not be construed as an official Department of Defense position, policy, or decision unless designated by other official documentation. Our theme song is “Upbeat-Corporate' by WhiteCat, available and was used according to the Creative Commons Attribution-Noncommercial 4.0 license.
In this episode of CUBIST, Amanda and Don discuss the article, "Risk Factors for high symptom burden three months after traumatic brain Injury and implications for clinical trial design: A TRACK-TBI study” by Nancy Temkin and colleagues published in the Journal of Neurotrauma in June of 2022. Article Citation: Temkin, N., Machamer, J., Dikmen, S., Nelson, L. D., Barber, J., Hwang, P. H., Boase, K., Stein, M. B., Sun, X., Giacino, J., McCrea, M. A., Taylor, S. R., Jain, S., Manley, G., & TRACK-TBI Investigators (2022). Risk Factors for High Symptom Burden Three Months after Traumatic Brain Injury and Implications for Clinical Trial Design: A Transforming Research and Clinical Knowledge in Traumatic Brain Injury Study. Journal of Neurotrauma, 39(21-22), 1524–1532. Article LINK: https://pubmed.ncbi.nlm.nih.gov/35754333/ CUBIST is a podcast for healthcare providers produced by the Traumatic Brain Injury Center of Excellence. We discuss the latest research on traumatic brain injury (TBI) most relevant to patient care. For more about TBI, including clinical tools, go to www.health.mil/TBICoE or email us at dha.TBICoEinfo@health.mil. The views, opinions, and/or findings in this podcast are those of the host and subject matter experts. They should not be construed as an official Department of Defense position, policy, or decision unless designated by other official documentation. Our theme song is “Upbeat-Corporate' by WhiteCat, available and was used according to the Creative Commons Attribution-Noncommercial 4.0 license.
NASH-TAG 2023 proved to be a watershed moment for Fatty Liver disease as exciting drug development readouts, powerful academic work on non-invasive tests and the willingness to dive into the toughest questions aligned in Deer Valley, Utah. In this weekend's conversation series, Surfing NASH reviews its diverse coverage of the conference by showcasing key excerpts across six recordings with various KOLs, patient advocates and stakeholders.This conversation featuring Stephen Harrison, Mazen Noureddin and Jörn Schattenberg begins with Mazen describing how exciting and informative the new sessions on non-invasive tests were. Specifically, he details his own surprise at how much LITMUS and NIMBLE were able to share. Jörn's main point: we will find more NITs, but do not need them to be able to push treatment far forward today. Roger Green suggests that correct classification metrics (based on the percentage of patients classified correctly) might be more important in practical treatment than other tests which have better positive or negative predictive values but have large “indeterminate zones” of patients the test does not predict for at all. Stephen compliments the NIT discussion and commends Mazen's observation that NASH is not the only disease area working its way through predictive non-invasive tests. Mazen shifts discussion onto the next session, where Vlad Ratziu, Rohit Loomba and Stephen Harrison investigate important areas in clinical trial design. Vlad discussed combination therapies, Rohit discussed gene SNPs and Stephen discussed cirrhosis.Stephen refocuses on the idea that by providing continuous scoring, NITs appear to provide better guidance on whether drugs are “working” or not. Mazen agrees, pointing out how high the bar is to label a patient treated with drug a success. As the talk winds down, Jörn notes that Intercept and Madrigal are providing data we can dive into for years. Lastly, Stephen describes the high value that AI-based digital pathology will provide in sorting out how many patients are improving using continuous measures.
Expert statisticians Janet Wittes and Eric Leifer join the podcast to discuss hazard ratios, the phenomenon of "hazard ratio drift", and other contemporary challenges in HF clinical trial design.
During the 2022 WCG MAGI Clinical Research Conferences in Boston and Las Vegas, Linda Sullivan invited attendees to stop by the CTO podcast booth and share their ideas about the top three things that the industry should do to improve how clinical trials are designed and executed. Don't miss this rare opportunity to hear ideas from investigative site staff, clinical trial participants, and other industry stakeholders about opportunities to improve clinical research.
This fundamental conversation is given a fresh perspective during one of the stand out moments of the recent Evidence Based Perioperative Medicine (EBPOM) Dingle conference. How do we define evidence in the era of big data? Can we further improve the speed at which we do trials and yet still gather reliable data? In the wake of COVID-19 what new innovations can be made to how we trial and test vital medical help? Chaired by Ramani Moonesinghe, OBE, Professor of Perioperative Medicine at University College London, Consultant in Anaesthetics and Critical Care Medicine at UCL Hospitals, this piece features; Mark Edwards, Consultant in Anaesthesia & Perioperative Medicine, University Hospital Southampton, Honorary Senior Clinical Lecturer, University of Southampton, Mike Grocott, Professor of Anaesthesia and Critical Care Medicine, University of Southampton and Matt Wilson, Anesthetist, UCL Hospitals and University College London and a PhD candidate.
One critical success factor for putting a dent in Fatty Liver disease – one we do not discuss very often on the podcast – is patient empowerment. In this conversation, Roger Green and Louise Campbell are joined by patient advocates Michael Betel, Wayne Eskridge and Robert Mitchell-Thain to discuss patients' perspectives and the extent they are considered in the clinical trial design process.Louise leads with the question: When planning drug trials, to what degree do BioPharma companies focus on the eventual needs of the patient? Each advocate expresses significantly different perspectives. Robert starts by answering a different question: Do companies “get it?” He states that of the myriad of views held by industry partners, his focus remains on harnessing the efforts of those championing patient-centricity. Michael refers to his unique experience of having worked both for commercial pharma and non-profit organizations. He believes that while the patient journey matters tremendously, it's not considered in the earliest stages of drug development. Wayne's answer echoes this sentiment while emphasizing that interest in patient needs is driven out of marketing, not clinical development. He does note patient sensitivity has improved in recent years. Roger follows up, spurring investigation into the distinction between driving perpetual drug use versus creating accessible, valuable therapeutic solutions. Robert carefully discloses his discomfort with industry and NAFLD, but not NASH. He states that all three guests have improved their lived experiences with NAFLD without medical intervention. For Robert, these successes correlate with early interventional lifestyle changes, highlighting the importance of peer support. Michael returns to his idea that drug companies seek to remove barriers that limit access to treatment. Wayne expresses concern for the potential of conflicting motivators to pit social values against the accountabilities a company holds for making market systems work.The conversation finishes with a segue into the future of digital therapeutics as a Pharma-supported patient wellness tool.
The 2022 NAFLD Summit presented a range of perspectives and insights on fatty liver and metabolic diseases. In this conversation, the panelists explore issues around clinical trial design, focusing specifically on the value of Phases 2a and 2b and whether improvement in patient self-management during trials is a research artifact or a replication of reality. This conversation addresses two issues in clinical trial design. First, Roger Green draws on the Session 9 discussion of failed trials to ask which is the right way to proceed when a drug in a Phase 2b trial fails to reach its primary endpoint but a subanalysis reveals a second possible path to Phase 3. He notes that this was the case with elafibranor, one of the Session 9 case studies, as well as obeticholic acid, a drug whose Phase 3 trials met its efficacy endpoints but is not yet approved due to regulators' seeming perception that it lacks an acceptable cost:benefit ratio. The group points to reasons these may have been solid decisions before noting that the market and scientific community both expect higher performance from drugs today than they did several years ago. Mazen Noureddin asks whether exceptionally promising drugs might consider moving directly from Phase 1b to Phase 3; the group agrees that Phases 2a and 2b will have value for virtually every drug at this time. The final question comes from Roger, who asks whether improvements in patients' diet and lifestyle during the clinical trial constitute a “Hawthorne effect,” as some stated on Saturday morning. He notes that in the literature, a Hawthorne effect is a change that might affect clinical trial results but will have no meaning in day-to-day practice. By that standard, improvements in patients' diets and lifestyles do not constitute a Hawthorne effect since we want to effect these behaviors in all patients. Mazen Nouredin disagrees, noting that after trials, patients' behaviors tend to revert to pre-trial levels, thus making improved behavior a confounding factor in analyzing trial results. The group comes to no clear consensus on this issue.This episode is sponsored by Resoundant, a Mayo Clinic company and the developers of Magnetic Resonance Elastography. MRE is widely available with over 2000 locations worldwide, and can be done as a low-cost, rapid exam in just 5 minutes. Together with PDFF, this quantitative exam is called an Hepatogram – a powerful non-invasive alternative to liver biopsy in many cases. For more information, visit www.resoundant.com on the web.
Cancer is one therapeutic area where patients cannot wait the conventional 10 or 12 years for a new therapy. For these patients, time is of the essence, and improved access to faster clinical trials can be the difference between receiving a new life-saving medicine and it being too late. In this episode, we talk to David Raben, vice president of Global Development Oncology at Amgen, about the next generation of oncology trial design and execution. To dive further into this topic, please join Amgen scientists at the Innovating Clinical Trials Q&A webinar discussion on September 28, 2022. Register for the event here. Welcome to Innovating Clinical Trials, a special edition podcast series produced by The Scientist's Creative Services Team. This series is brought to you by Amgen, a pioneer in the science of using living cells to make biologic medicines. They helped invent the processes and tools that built the global biotech industry, and have since reached millions of patients suffering from serious illnesses around the world with their medicines. Clinical trials are desperate for innovation. Speed and efficiency need to improve as many patients cannot wait over a decade for new, potentially lifesaving medicines, and trial participants often do not reflect the patient population. Because clinical trials are complex and multidisciplinary, there is not a single, simple solution for accelerating progress. In this series, Rob Lenz, senior vice president of Global Development at Amgen, explores the latest approaches in clinical trial design and execution and highlights real-world examples of how scientists can run trials better and faster to develop optimal medicines that benefit patients.
ONCE UPON A GENE - EPISODE 145 Ensuring that the Patient and Caregiver Voice are Part of Clinical Trial Design and Engagement - Bridging the Gap with Industry with Shazia Ahmad Shazia Ahmad is the Senior Director and Head of Patient and Physician Services at UBC. She earned a BS in physiology and neurobiology from the University of Maryland and has over 20 years of experience in the therapeutic development industry. EPISODE HIGHLIGHTS Can you talk about your work designing clinical trials? I started my career at the NIH as a Research Coordinator and that's where my work in rare diseases and infectious disease started. I worked closely with patients, parents, caregivers, and care partners. At UBC I've been involved in heading up the patient services division which handles patient advocacy and stakeholder engagement. What invigorates my passion for the rare disease space is my own personal journey. I have a daughter with Kawasaki disease (KD). Because we received a diagnosis in a timely way before going into phase two of KD, we were able to get treatment for her to recover completely. It left a mark on me in my career moving forward to focus on integrating advocacy and understanding the patient journey, and the impact on the families in any program that I would support in healthcare moving forward. Why should families seek out clinical trials? I think it's so important for families to understand the impact that their participation could make in participating in clinical trials because it's hope and a possible treatment. But most importantly, it's helping the overall patient community for that particular diagnosis, which is huge and it's critical. What transformational changes are you seeing around designing trials and gathering a more diverse population? As I work on clinical trials, I'm seeing more advocacy organizations partnering with the industry and making an impact early on. I'm also seeing a lot of the new technologies coming out for improving diagnosis, creating more communication, education and awareness about rare diseases in general, not just clinical trials. There's a lot of good collaboration going on within patient communities. What are the gaps with industry right now and how do we bridge that with advocacy? Industry is starting to do a better job in understanding the journey and bringing that into design and implementation. What often happens is they complete the clinical trial and sometimes that awareness and continuous conversation with that patient community is not ongoing. We need more community building within industry to keep those communities engaged and there are gaps there. We also need more sponsors to work together. There's so much that we could do if we really conquer some of these rare diseases together and come together as a community to create a bridge where we can learn from each other. LINKS & RESOURCES MENTIONED Global Genes Patient Advocacy Summit https://globalgenes.org/event/rare-patient-advocacy-summit/ UBC https://ubc.com/ Shazia Ahmad - Linkedin https://www.linkedin.com/in/shaziakahmad TUNE INTO THE ONCE UPON A GENE PODCAST Spotify https://open.spotify.com/show/5Htr9lt5vXGG3ac6enxLQ7 Apple Podcasts https://podcasts.apple.com/us/podcast/once-upon-a-gene/id1485249347 Stitcher https://www.stitcher.com/podcast/once-upon-a-gene Overcast https://overcast.fm/itunes1485249347/once-upon-a-gene CONNECT WITH EFFIE PARKS Website https://effieparks.com/ Twitter https://twitter.com/OnceUponAGene Instagram https://www.instagram.com/onceuponagene.podcast/?hl=en Built Ford Tough Facebook Group https://www.facebook.com/groups/1877643259173346/ Once Upon a Gene TV https://www.thedisordercollection.com/
Thursday, June 9, marked #NASHDay 2022, the 5th annual celebration of International NASH Day by the world's largest liver patient advocacy organization, the Global Liver Institute. To celebrate the occasion, Stephen Harrison joined Jörn Schattenberg, Louise Campbell and Roger Green to celebrate the event and comment on one crucial trend or event most signified what the last year has meant in the Fatty Liver community.Roger's first question was for each panelist to describe a major event that took place since the 4th International NASH Day last June. Stephen Harrison answers first by discussing major advances in clinical trial design. This conversation consists of his answer.Stephen Harrison describes two related areas where we have made what he describes as “real, granular progress in drug development” in terms of rethinking the design of Phase 3 clinical trials and endpoint assessment related to this redesign. Historically, sponsors conducted a single, very large, very long trial that sought first to achieve conditional approval based on sub-part H endpoints in fibrosis and then to achieve full approval based on outcomes developed as the initial trial group progresses to cirrhosis. The new idea is to conduct the fibrosis and cirrhosis elements in parallel, thus shortening the time to approval, simplifying endpoints and reducing the cost of the overall trial process. It is a vision of breathtaking scope…and, Stephen reports, it's almost ready to launch.
Thursday, June 9, marked #NASHDay 2022, the 5th annual celebration of International NASH Day by the world's largest liver patient advocacy organization, the Global Liver Institute. To celebrate the occasion, Stephen Harrison joined Jörn Schattenberg, Louise Campbell and Roger Green to celebrate the event and comment on one crucial trend or event most signified what the last year has meant in the Fatty Liver community.This conversation consists mostly of reactions from Jörn Schattenberg, Louise Campbell and Roger Green to Stephen's initial statement, followed by other thoughts from Stephen. The other Surfers are all impressed by the trial design. In response to a comment from Roger, Stephen comments enthusiastically on the unprecedented collaboration between sponsors, academics, regulators – the entire range of stakeholders – to resolve this issue. He goes on to note other questions – for example, the name of the disease – where the community is demonstrating unparalleled collaboration. All of this, he says, is leading to a proliferation of new research so vast that no one can keep up with all of it. There are three more points in this conversation:• Jörn raises Quentin Anstee's comments from Episode 26 that we need to develop a standard set of NITs to use in the evaluation process as another area where collaboration will be key• Stephen points out that we may see our first drug approval in 2023, which will add new levels of energy and resourcing to the development and education processes• Jörn begins to discuss his issue, which is the convergence between conferences to cover a range of issues that look past simple drug development to improve key questions from drug evaluation to clinical care pathways and inter-specialty collaboration to treat patients
Drs. Singer and Pieramici discuss if there is a disconnect between the dosing in clinical trials and real world dosing. Dr. Pieramici takes us through the history of retinal therapy clinical trial dosing and the objective of newer trial designs and dosing. Both experts share how clinical trial data inform their clinical practice because patients are quite variable and how the “art” of medicine truly comes into play.
In this episode, Danielle Bodicoat and Duane Mancini discuss being a biostatistician (medical statistics), why she started her own consulting practice, the importance of clinical evidence beyond regulatory requirements, the cost drivers of a clinical trial, factors that go into clinical trial design, the basics of sample size calculation, clinical evaluation plans and clinical evaluation reports, the MDR and how it is affecting clinical in the EU and UK, and so much more. Danielle Bodicoat LinkedIn Danielle Bodicoat Website Project Medtech Website Duane Mancini LinkedIn Project Medtech LinkedIn
SurfingNASH invited four attendees to the NASH-TAG wrap up (three first-timers, two corporate executives) to focus on presentations and discussion from the fireside chats. Highlights include:4:20 – Introduction of first-time panelists Amy Articolo (Novo Nordisk), Erin Quirk (Terns Pharmaceuticals), Rachel Zayas (AGED Diagnostics) and the returning Ian Rowe (University of Leeds)12:55 – Opening question: what about NASH-TAG 2022 surprised you most?13:04 – Consensus: energy and passion. Rachel mentioned the vast divergence in balloon hepatocyte readings16:19 – Led by Stephen, group discusses powerful single slides22:51 – Question: What single presentation had a real impact on your thinking?23:04 – Rachel: Single Cell Transcriptomics, which can identify disease drivers. 25:53 – Ian: Scott Friedman's point about the need to balance blocking fibrosis with maintaining sufficient collagen for scar healing.27:16 – Amy: Talks about upstream effects resonated because Novo Nordisk works to develop combination therapies.28:53 – Erin: One “pleasant takeaway” was big companies sharing findings “shoulder to shoulder” with smaller ones.30:04 – Roger: Rate reaction to fireside chats using 6-point scale. Erin, Amy, Rachel all say 5. Liked diverse viewpoints, high energy level. Ian says 4, maybe 3. Fears that following the path laid out in meeting will lengthen drug development. 36:06 – Stephen: We need to improve use of histopathology, design and implement a multi-year path to NITs as outcome drivers and develop NAIL-NIT, a multi-company, “agnostic” data repository to utilize everyone's data to “ask the big questions” and drive large prospective trials. Also, we should provide analytics and perspective on unresolved issues that are delaying final FDA guidance document47:02 – Amy: Key is to impact patients' lives, which is more “function and feel,” less survival. We'll look back on this as "The moment of change” 48:59 – Roger: FDA has becoming more open and encouraging since 01/21 webcast 50:33 – Roger: Stephen's push to lower screen fail rates from 80% to 50% will drive 2.5x increase in eligible patients, thus shortening trials, reducing costs 52:35 – Stephen: This can also reduce placebo response rates, which are a major issue in interpretation 54:27 – Erin: Should we even be looking at liver tissue when pathologists are so mislaligned on balloon hepatocytes? Stephen: Eventually, perhaps not. But the ongoing trials today have to rely on histology55:02 – Erin: Are we creating medications that patients actually will want to take, given that many choose not to participate in trials? Louise: Decision is individual, but those who take time to make it wisely have the greatest prospects for success57:14 – Ian: Findings from trial populations and natural history populations can vary widely. Also, the NITs we use in trial need to work financially for the larger population59:20 – Amy: Expanding trial population into primary care or OB/GYN would broaden target dramatically1:01:02 – Question: something you hope to see that is different in a year and something you believe you will see1:01:14 – Louise: Patients and advocates at future Fireside chats1:01:29 – Rachel: Tests that look separately at the different NAS elements instead of creating composite scoring1:02:02 – Erin: A positive Phase 3 study result1:02:31 – Amy: Solid and actionable programs to create solutions to issues identified this past weekend1:03:03 – Ian: Expect positive Phase 3 data. Hope to see discussion around NITs that correlate consistently with histology and drive changes in outcomes1:03:21 – Stephen: Hope to report positive Phase 3 trial1:05:04 – Roger: Believe AI histopathology will play larger role; hope this entails more than simply emulating human brain 1:08:03 – Busines
We talked with Teckro's Dr. Brendan Buckley about his latest blog Mega-Trials vs. Personalized Medicines. In this podcast, we discuss the design and execution of trials at different ends of the spectrum, a new clinical trial he's watching closely, and why you shouldn't be worried about the COVID-19 vaccine.“What you're really doing is standing on the shoulders of the developers of these drugs, seeing if one can reach a new disease, and repurposing the drug for the benefit of people with that condition.”
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we're talking with Nadim Yared, the CEO of CVRx, a pioneer in neuromodulation for cardiovascular diseases. Nadim has been CEO for 15 years and led CVRx through some major pivots and incredible successes. Today, we're going to discuss his journey with the company, including Nadim's expertise on clinical trial strategy, startup funding, and working with FDA & CMS. But first, here's a bit more about Nadim Yared and his background: Nadim holds two graduate degrees, and started his career with GE. After getting his MBA at INSEAD, he went on to run several business units for GE, then spent four years as the head of Medtronic's Surgical Navigation division. Nadim was then recruited to take the helm at CVRx in 2006, and has been CEO ever since. Before we jump into the conversation, I wanted to mention a few things:If you're into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You'll get access to gated articles, and lots of other interesting healthcare content. Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, Premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world's most successful medtech founders and executives. Since making the premium memberships available, I've been pleasantly surprised at how many people have signed up. If you're interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Nadim Yared if you'd rather read it instead.
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