Podcasts about trial design

Tuesday, February 17, 2026 - Week 8   We are flat out, thank you to the team who work full-time on SYNGAP1: VM KAH LP PP & KF.   CLINICAL TRIAL DESIGN We are Angelman-like. (Rett also) https://aesnet.org/abstractslisting/differentiating-key-symptoms-of-angelman-syndrome-as-and-syngap1-via-caregiver-reported-and-us-claims-data-to-understand-differences-between-how-providers-and-caregivers-view-impacts-on-patient-care Dravet or Angelman?  Phase 1/2 is when we try it all.  EEGs and NHS help with this effort.   BIOSAMPLES & EEGs! Biorepository needs more samples.  Check out the list and map here https://combinedbrain.org/roadshow/ and contribute both blood & EEGs.  The data and research we do with these samples is invaluable.  Let us know if you are going, email our CSO@curesyngap1.org.   (Stay tuned for another exciting device study…)   NATURAL HISTORY STUDY Sign up for Citizen Health cureSYNGAP1.org/Citizen and ProMMiS cureSYNGAP1.org/ProMMiS NHS Survey in English: https://curesyngap1.org/SurveyProMMiS & Spanish: https://curesyngap1.org/encuestaProMMiS Latest Pod on NHS: https://youtu.be/7W38uWKBIAw?si=lCrffwMXidmYWz7t   FUNDRAISING - SPRINT4SYNGAP Sprint is April 25 - our calendar page - cureSYNGAP1.org/Sprint - has all the information in the following links: set up your team - cureSYNGAP1.org/Sprint26 resource guide for your event - cureSYNGAP1.org/S4SGuide webinar #99 to help get you started - cureSYNGAP1.org/S4S25   Also, May 28, San Francisco, CA: cureSYNGAP1.org/SF26 Scramble for Syngap - 5th annual on October 3 in S. Carolina cureSYNGAP1.org/Scramble26   PUBMED Pubmed 2026 is at 9! https://pubmed.ncbi.nlm.nih.gov/?term=syngap1&filter=years.2026-2026&sort=date (Remember we had 18 in all of ‘18) Cool connection to #PraderWilli Syndrome. https://www.linkedin.com/posts/graglia_syngap1-praderwilli-autism-share-7429579885985296385-zuIH   ETC - More warriors cureSYNGAP1.org/Warrior - Dr. Donlin-Asp Press Release cureSYNGAP1.org/PR42 see talk here https://www.youtube.com/watch?v=lR8qcZK-9ro - Bravo Sara Driscol and GeneDx https://www.linkedin.com/posts/genedx_beyondawareforrare-ugcPost-7427763511235248129-QPPL?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAAD8f4B7JC4TMss45Q8hrsq5kiceI0Z8HE   SOCIAL MATTERS 4,686 LinkedIn.  https://www.linkedin.com/company/curesyngap1 1,520 YouTube.  https://www.youtube.com/@CureSYNGAP1 11.2k Twitter https://twitter.com/cureSYNGAP1 45k Insta https://www.instagram.com/curesyngap1   $CAMP stock is at $3.85 on 17 Feb. ‘26 https://www.google.com/finance/beta/quote/CAMP:NASDAQ   Like and subscribe to this podcast wherever you listen.  https://curesyngap1.org/podcasts/syngap10/ Episode 199 of #Syngap10 #CureSYNGAP1 #Podcast

Why Real-World Use Doesn't Replace Trials; Placebo Effect and Clinical Trial Necessity; Raw Data Ownership Enables Manipulation; Empowering Patients Through Labels and Questions; Reading Drug Labels Reveals True Efficacy; Product Monographs as Trusted Resources; Many Widely Used Drugs Lack Long-Term Data; Limited Access to Raw Trial Data Even Through Labels; Therapeutics Initiative Offers Publicly Accessible Evidence; System Manipulation Persists in 2025; Covid Boosters Approved Without Efficacy Trials #PharmaTruth #EvidenceBased #MedicalEthics #HealthTalks

In this week's episode, Blood editor Dr. James Griffin interviews Drs. Paresh Vyas and Andrew Hantel on their research published in this week's issue of Blood. Dr. Vyas discusses his paper, "Rapid clonal selection within early hematopoietic cell compartments presages outcome to ivosidenib combination therapy", which provided new insights as to when and how to intervene to circumvent resistance to AML remission. Dr. Hantel will speak about his paper, "Impact of Modernizing Eligibility Criteria on Enrollment and Representation in AML Clinical Trials". For a real-world cohort of more than 2200 patients with AML, they reported that modernized, safety-based criteria could nearly double trial eligibility, with especially pronounced gains among historically underserved groups.  Both studies highlight how biologic insight and thoughtful trial design can drive more effective, inclusive advances in AML treatment and research. 

Today's guest is Emma Vitalini, Head of Global Digital Health Technology Innovation at Amgen, where she leads initiatives at the intersection of digital health, data strategy, and clinical innovation. Emma joins Emerj Editorial Senior Editor Marilie Fouche to explore how data and AI are reshaping patient recruitment, consent, and execution in clinical trials, with a focus on decentralized models, scalable compliance, and explainable AI in regulated environments. Emma also shares practical guidance for enterprise leaders on where AI is delivering near-term ROI today, including accelerating patient screening by surfacing unstructured data, reducing enrollment delays through digital and remote monitoring tools, and designing modular, plug-and-play AI platforms that balance speed, flexibility, and regulatory trust. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the 'AI in Business' podcast! If you've enjoyed or benefited from some of the insights of this episode, consider leaving us a five-star review on Apple Podcasts, and let us know what you learned, found helpful, or liked most about this show!

Today's clip is from episode 148 of the podcast, with Scott Berry. In this conversation, Alex and Scott discuss emphasizing the shift from frequentist to Bayesian approaches in clinical trials. They highlight the limitations of traditional trial designs and the advantages of adaptive and platform trials, particularly in the context of COVID-19 treatment. The discussion provides insights into the complexities of trial design and the innovative methodologies that are shaping the future of medical research. Get the full discussion here!• Join this channel to get access to perks: https://www.patreon.com/c/learnbayesstats • Intro to Bayes Course (first 2 lessons free): https://topmate.io/alex_andorra/503302 • Advanced Regression Course (first 2 lessons free): https://topmate.io/alex_andorra/1011122 Our theme music is « Good Bayesian », by Baba Brinkman (feat MC Lars and Mega Ran). Check out his awesome work at https://bababrinkman.com/ !

How This Is Building Me, hosted by world-renowned oncologist D. Ross Camidge, MD, PhD, is a podcast focused on the highs and lows, ups and downs of all those involved with cancer, cancer medicine, and cancer science across the full spectrum of life's experiences. In this episode, Dr Camidge sat down with Tom Fleming, PhD, a professor of biostatistics at the University of Washington School of Public Health in Seattle. Drs Camidge and Fleming discussed how Fleming's interest in biostatistics led to a multifaceted career in clinical trial design and analysis. Fleming pursued a PhD in math and statistics and spent his early career learning to bridge quantitative sciences with clinical medicine, working on landmark trials for adjuvant colon cancer and debunking megadoses of Vitamin C as a cancer treatment. A primary focus of Fleming's career was pioneering the use of Data Monitoring Committees (DMCs) in oncology research to safeguard patient interests and trial integrity, later convincing organizations like SWOG to adopt DMCs to prevent premature data releases and biases. He also co-developed the O'Brien-Fleming monitoring boundary, a statistical framework that allows trials to stop early for efficacy only when the signal is undeniably compelling, thereby protecting scientific rigor. After moving to the University of Washington, Fleming expanded his focus into infectious diseases. He led international efforts that revolutionized HIV/AIDS prevention, including demonstrating a reduction in heterosexual transmission of the disease through antiretrovirals and significantly reducing mother-to-child transmission in resource-limited settings. Fleming remains a staunch advocate for confirmatory trials and the use of overall survival as the "gold standard" end point, often expressing skepticism toward surrogate biomarkers like progression-free survival. In the episode, he emphasized that rigorous science is possible even in the most challenging environments, provided there is a commitment to clinical equipoise and high patient retention. Outside of his professional life, Fleming prioritizes family and coaches youth soccer teams, reflecting his belief in the power of collaboration.

There have been nearly 30 years of disease modifying trials for PD, but little success. Prof. Tanya Simuni breaks down clinical trial design for a heterogenous disease like PD and discusses the future goals and importance of a biological definition.

What makes a biotech-CRO partnership truly work? Claire Riches, VP, Clinical Solutions, Citeline, and Matt Simmons, Senior Director, Oncology Strategy, IQVIA Biotech, share the secrets behind winning biotech-CRO partnerships, covering collaboration, transparent budgeting, regulatory navigation, and recruitment strategies, with essential insights to help biotechs succeed from their first RFP to global trials. View the video series and find out more information here: https://www.citeline.com/biotech

"But did you bleed him? - Aesculapius says that bleeding is not a cure. It is only a way of proving that you are a physician at the expense of your patient." Finally, we discuss the EPI-321 epigenetic editing phase I/II clinical trial design and its potential for answering key questions necessary for going to phase III and for providing benefit to participants and patients.

Maria Mori Brooks, PhD, University of Pittsburgh School of Public Health, discusses "Assessing Unexpected Circumstances That Lead to Modifications in Clinical Trial Design, Conduct, or Analysis" in the JAMA Guide to Statistics and Methods series, with JAMA Statistical Editor Roger J. Lewis, MD, PhD. Related Content: Assessing Unexpected Circumstances That Lead to Modifications in Clinical Trial Design, Conduct, or Analysis

In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety profiling to pivotal phase three trials. She also discusses the importance of patient diversity, the ethical considerations in clinical research, and the future of clinical trials, including decentralized trials and the use of advanced technologies. The conversation highlights the intricate balance between maintaining rigorous scientific standards and adapting to new methodologies to enhance patient recruitment and data integrity. Time Stamps: 00:00 Welcome and Introduction 00:28 Understanding Clinical Trial Design 00:58 Phases of Clinical Trials 02:27 Oncology Trials and Patient Pathways 05:00 Protocol Design and Regulatory Considerations 08:40 Patient Preferences and Vendor Selection 18:53 Types of Clinical Trials 23:01 Understanding BA and BE Studies 24:39 Clinical Coordination of BA/BE Studies 25:15 Infrastructure and Emergency Management in Clinical Trials 26:19 Addressing Mistrust in Clinical Trials 29:54 Ensuring Diversity in Clinical Trials 32:41 The Rise of Decentralized Clinical Trials 39:06 Challenges and Solutions in Decentralized Trials 42:49 Technology and Regulation in Clinical Trials 47:28 Final Thoughts and Contact InformationArchana Sah is a Clinical development thought leader with extensive (30 years) experience and passion for developing medicines for patients having led and contributed to 15 FDA/EMEA drug approvals including Tecentriq® in multiple indications and combinations, Alecensa®, Polivy®, Hemlibra®, Gazyva®, Pixuvri®. She has held various global positions within Biotech, Big pharma, CRO including Genentech/Roche, Bayer Oncology, Johnson & Johnson, ICON, and two Oncology biotech start up companies. She has also worked in healthcare technology as the Senior Vice President of Digital and Decentralized Solutions at Medable Inc. She is now an independent strategy consultant and Board Advisor and provides strategic advisory services to pharma, biotechs, digital healthtech software companies, venture firms in clinical development and operations as well as on leveraging innovative patient centered digital health technologies in a fit for purpose approach to improve diversity, access and efficiencies within the healthcare ecosystem. She has been honored as Top20 women in immuno oncology drug development and featured in PharmaFEATURES on Oncology drug development and Digital Health technology.She has routinely led several industry collaboration consortiums. She is the co-founding chair and member of Society for Clinical Research Sites Oncology Board and chaired the Annual Oncology Summits. She is a current Mentor for the CancerX Moonshot program dedicated to revolutionizing advancements in cancer care, clinical trials, patient support, biotech & pharma and drive integration of digital tools in oncology. She serves on the Leadership Council for Decentralized Trials and Research Alliance(DTRA) and as their Evidence/Publications Librarian. She also serves as an Advisor to American Cancer Society Cancer Action Network (ACS CAN) and is a reviewer for the international Journal of the American Cancer Society "Cancer". Invited advisor and keynote/speaker at several industry conferences.Contact: archana.sah@aspharmaadvisors.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics.Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee.

In this episode of Alter Everything, we chat with Patrick Leung, CTO of Faro Health, about the innovative ways his company is using generative AI to revolutionize the clinical trial process. They discuss handling unstructured data, insights generated by AI to optimize trials, and significant cost savings in the pharmaceutical space! Not sure what a clinical trial is? Fear not! Patrick explains the structure of clinical trials, Faro Health's AI-driven enhancements in medical writing, and the importance of data extraction and analysis.Panelists: Patrick Leung, Chief Technical Officer @ Faro Health - LinkedInMegan Bowers, Sr. Content Manager @ Alteryx - @MeganBowers, LinkedInShow notes: Faro HealthAlteryx's Generative AI for AnalyticsClinicaltrials.gov Interested in sharing your feedback with the Alter Everything team? Take our feedback survey here!This episode was produced by Megan Bowers, Mike Cusic, and Matt Rotundo. Special thanks to Andy Uttley for the theme music and Mike Cusic for the for our album artwork.

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

In this must-listen episode of AI for Business Growth, host Dr. Andre Bates is joined by Damond Rasheed, Executive Director at Opyl (makers of Trial Key, an AI SaaS platform for clinical trial design). Together, they unpack how artificial intelligence is transforming rare disease clinical trials, solving real-world bottlenecks in patient recruitment, adaptive trial design, and biostatistical validation using advanced machine learning models and real-world evidence (RWE).Damond shares candid insights from his journey—starting as a card-counting economist turned AI innovator—and details how AI can simulate and optimize clinical trial outcomes, even with limited datasets, fragmented information, or under-researched rare diseases.Learn how platforms like Trial Key are helping biotech and pharma companies:Predict clinical trial success probabilitiesOptimize patient cohort sizes and timelinesIntegrate digital biomarkers and real-world data for better decision-makingAddress ethical considerations and data biasExpand globally across the US, UK, and beyondWhether you're a clinical research professional, digital health entrepreneur, AI data scientist, or healthcare investor, this episode is packed with actionable takeaways on leveraging AI to reduce costs, shorten trial timelines, and increase approval success—especially in rare and complex disease landscapes.What You'll Learn in This Episode:How AI models predict clinical trial success with high accuracy (AUC ~0.8)Why rare disease trials benefit disproportionately from AI optimizationChallenges in accessing high-quality patient-level dataThe ethical imperative of simulating trials before involving human patientsHow language models like ChatGPT are being used to analyze unstructured clinical trial dataAI vs. traditional power tests in enrollment planningUse of synthetic data to reduce bias in training datasetsHow Opal is driving trial innovation globally from Australia to the US and UKAbout the Podcast: AI for Business Growth is a podcast focused on exploring how artificial intelligence can revolutionise healthcare by addressing disparities and creating equitable systems. Join us as we unpack groundbreaking technologies, real-world applications, and expert insights to inspire a healthier, more equitable future.This show brings together leading experts and change-makers to demystify AI and show how it's being used to transform healthcare. Whether you're in the medical field, technology sector, or just curious about AI's role in social good, this podcast offers valuable insights.AI For Business Growth is the podcast from pioneering Pharma Artificial Intelligence entrepreneur Dr. Andree Bates created to help organisations understand how the use of AI based technologies can easily save them time and grow their brands and business. This show blends deep experience in the sector with demystifying AI for all pharma people, from start up biotech right through to Big Pharma. In this podcast Dr Andree will teach you the tried and true secrets to building a pharma company using AI that anyone can use, at any budget. As the author of many peer-reviewed journals and having addressed over 500 industry conferences across the globe, Dr Andree Bates uses her obsession with all things AI and futuretech to help you to navigate through the, sometimes confusing but, magical world of AI powered tools to grow pharma businesses. This podcast features many experts who have developed powerful AI powered tools that are the secret behind some time saving and supercharged revenue generating business results. Those who share their stories and expertise show how AI can be applied to sales, marketing, production, social media, psychology, customer insights and so much...

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

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.

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.” 

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.

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.

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/

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