Unblinded: A Clinical Trial Podcast

Joel White, owner of Marketcap Consulting, together with Veeva’s Chris Kreitel, joins Manny to discuss why the next era of clinical trial outsourcing will be defined by technology integration and economic agility. They debate whether CROs are the ultimate masters of integrating tech, and the role of small biotechs as growth drivers in the market.

Anna Hayes, senior director of clinical data management at Veramed with nearly 20 years in CRO data and project management. Noeleen Turner, head of clinical data management at UCB with pharma leadership across Pfizer and GSK. They discuss platform vs point solutions, people and change management, endpoint-driven design, risk-based data practices, unified platforms, and calls for leaner, greener trials.

Cheryl Grandinetti, FDA clinical policy leader with a pharmacy background, and Lisbeth Bregnhoj, Danish GCP inspector and pharmacist, talk ICH E6(R3) changes. They discuss the new data governance chapter and shifting from rigid processes to purpose-driven, risk-based trial design. Conversations cover defining Critical-to-Quality factors, harmonizing regional language, and reducing site burden while improving inspection alignment.

Brian Johnson, former head of R&D technology at Takeda, now consultant, shares his unique perspective on a topic that’s top-of-mind for many: how do you introduce new technologies and processes without alienating the people who need them most?   He and Manny also tackle the critical issue of health equity, examining how technology can help diversify clinical trials and, in turn, create a more equitable future for all. Join us as we explore the business case for change and the crucial steps needed to unstick the industry from its current trajectory.

Manny is joined by co-host Denali Rose and MSKCC’s Joe Lengfellner, to discuss the shifting focus from a one-size-fits-all approach to redefine site centricity. They talk about how the role of a clinical trial coordinator is changing, the challenges of managing data and protocol amendments across different systems, and the promise of technologies like EHR-to-EDC to streamline workflows. They debate the potential of LLMs to revolutionize patient recruitment and widen access to clinical trials, addressing the critical issue of reaching more diverse patient populations.

In this enlightening discussion, Joyce Moore, a patient recruitment expert with 25 years of experience, shares her insights on making clinical trials more patient-centric. Joyce emphasizes the need to view patients as collaborators rather than mere subjects. She explores the delicate balance between data collection and patient comfort, highlighting the role of technology in enhancing experiences. Joyce also underscores the importance of keeping participants informed about their data, advocating for early patient involvement to foster better engagement and compliance.

In this insightful discussion, Doug Bain, founder of ClinFlow, Drew Garty, CTO at Veeva, and Robert Bergann, leader of clinical digital innovation at Bayer, delve into the transformative power of AI in clinical development. They share practical AI use cases like pattern detection and the innovation of automated study builds. The guests also discuss the importance of human oversight in AI outputs, effective governance for AI strategies, and the need for proactive detection methods. Their call to action emphasizes focusing AI on patient benefits and quality data.

Manny Vazquez chats with Trishna Bharadia, a passionate patient engagement consultant and advocate, dedicated to making healthcare more patient-centered since her own life-altering diagnosis 15 years ago. They delve into how involving patients early in clinical trial design can lead to breakthroughs in care. Trishna shares insights on overcoming challenges and emphasizes the necessity of diverse patient perspectives. The conversation envisions a healthier future by advocating for equity and removing barriers to access in the medical field.

Brad Hightower, owner of Hightower Clinical, dives into the challenges of balancing technology with clinical trial efficiency. He discusses whether the increasing tech burden is justified for progress and shares insights on how sponsors can ease site operations. The conversation highlights the implications of recent FDA guidance on decentralized trials and the importance of fostering communication between sites and sponsors. Brad also teases the upcoming ‘Save Our Sites’ conference aimed at revolutionizing site support.

Ibrahim Kamstrup-Akkaoui, Vice President for Clinical Data Operations at Novo Nordisk, shares insights from his journey in IT and clinical data management. He discusses the rapid growth of data in clinical trials and how AI can be harnessed to manage this effectively. Key topics include the transition from legacy systems to robust digital platforms, the importance of patient-centric design, and practical AI applications that enhance efficiency in trial setups. Ibrahim emphasizes starting small with innovative solutions while keeping a visionary outlook for scaling technologies.