DCRI Think Tanks demonstrate what is possible when you bring smart people together to tackle the biggest challenges in clinical research. From developing innovative approaches to addressing diversity and inclusion to leveraging artificial intelligence, these meetings are about creating pathways to useful, focused discussions across the healthcare continuum and then moving consensus to action.
Our mission: Address the most critical gaps in clinical research by convening leaders across the healthcare industry to map the way forward in designing, conducting, and implementing high-quality, evidence-based research.
Spotlight on Anti-Obesity Pharmacotherapy
Attending AHA 2024 in Chicago? Stop by DCRI's booth 702 to speak with the strategic leaders of our DCRI Think Tanks.
Obesity impacts the lives of ~150 million individuals in the U.S. Not only does it affect every facet of the lives of these individuals, but it also results in a societal cost of ~425 billion USD annually. With recent advances in anti-obesity therapy, the healthcare system finds itself in a situation where a chronic condition that affects a large proportion of the population is now eligible for highly effective but currently expensive therapies.
The October 2024 DCRI Think Tanks meeting on “Anti-Obesity Pharmacotherapy: An Urgent Need for Guidance, Access, and Equity” aimed to tackle this issue head-on by bringing together partners from academia, government, industry, and patient/community organizations to discuss:
- Redefining obesity: Moving beyond simplistic BMI-based definitions to capture the complexity of this chronic neuroendocrine disease.
- Evaluating anti-obesity medications (AOMs) value and costs: Accounting for long-term clinical outcomes, not just upfront medication prices.
- Ensuring equitable access: Addressing disparities in obesity prevalence and treatment, starting with representative clinical trials.
Watch the videos of our strategic collaborators and read the meeting brief to learn more about the landscape, challenges, and next steps discussed by our partners at this meeting.
Upcoming Think Tanks
Making Adaptive Platform Trials Fit to Host Registration Trials of New Drugs and Devices
January 29 & 30, 2025
Given the rapid advancements in science, the pressing health needs, and the drive for greater efficiency, how can we develop platform trials that lead to regulatory-grade analysis in support of registration? Biotechnologies that have the capacity to and are tested for the treatment of multiple diseases will continue to evolve. A single medical product could be crucial for various overlapping populations, which traditionally would have been developed and implemented sequentially. This DCRI Think Tank will explore platform trial designs that can span different therapeutic areas and/or leverage precision medicine for simultaneous clinical investigations that lead to regulatory-enabling endpoints to inform registration with regulatory bodies.
Key Questions
- In recent years there has been an explosion in adaptive platform trials, especially for COVID treatments. These trial designs are generally not leveraged for registrational trials – how do we make use more frequent for pivotal trials?
- What are the opportunities and challenges to address for therapies that could be developed for registration using a platform model?
- What are the considerations for platform approaches or scenarios where this would be advantageous for multiple indications, different populations, and at different stages of development?
- What is the value proposition for advancing therapeutics across multiple indications regarding risks, rewards, and cost?
- What are the misaligned incentives across stakeholders that prevent use of platform trials?
- What does sponsorship look like?
- What are the logistical barriers and challenges with data management?
- What solutions have been utilized to address the logistical barriers in implementation of platform designs?
- How can platform designs accelerate early clinical development and support decisions for late-stage development?
Think Tank Co-Directors
Expert Meetings & Resulting Insights
For over 30 years, DCRI Think Tanks have convened leaders across the healthcare industry to map the way forward in designing, conducting, and implementing high-quality, evidence-based research. Below, learn about our most recent meetings and read insights from leading experts, or visit our archive of meetings and publications.
Recent DCRI Think Tanks
DCRI Think Tanks brought together leaders from academic, regulatory, payor, policy, industry, and patient stakeholder groups to tackle the major issues in anti-obesity medication development. Discussions delved into the transformational change in the landscape of anti-obesity pharmacotherapy, health targets for obesity treatment, regulatory policies, clinical trial design, health system and payor implications, and a thoughtful examination of ethics and equity in obesity research and care. The obesity use case is a framework for the clinical research ecosystem to adapt to groundbreaking innovations with widespread uptake to optimize overall health.
Meeting attendees discussed the following themes and opportunities for action:
- What therapeutic targets to optimize overall health, beyond weight reduction alone, should we aim for in patients with obesity?
- How can guidance from regulatory authorities be updated to facilitate efficient and equitable research in the obesity therapeutic space? How will this impact clinical/registration trial design?
- How can we address access issues related to cost, coverage, and drug shortages?
Directors: Neha Pagidipati, MD, MPH, DCRI, and Ania Jastreboff, MD, PhD, Yale University; Meeting Fellow: Pishoy Gouda, MB, BCH, BAO, MSC
In May 2024, DCRI Think Tank collaborators investigated the potential applications of real-world data (RWD) in randomized clinical trials by sharing prior experiences, identifying barriers, and proposing solutions acceptable to clinical researchers, healthcare communities, and regulators in both the U.S. and Europe with the intention of identifying efficient and appropriate approaches to integrate RWD in randomized clinical trials.
Meeting attendees discussed the following themes and opportunities for action:
- RWD are useful for clinical trials, but infrastructure is still lacking.
- Identify challenges in acceptability of RWD use and develop an educational process to overcome these challenges.
- The clinical research ecosystem can and must be simplified.
- Use of RWD requires careful consideration of fitness for purpose.
- Support collaboration, cooperation, and partnership between sponsors and regulatory authorities.
Directors: Lisa Wruck, PhD, DCRI, and Stefan James, MD, PhD, Uppsala University; Meeting Fellow: Nina Nouhravesh, MD
In January 2024, a DCRI Think Tank session on “Embracing Generative Artificial Intelligence (AI) in Clinical Research and Beyond” brought together leadership from academia, industry, government, agency, and payer groups to explore the current and potential future application of AI/Large Language Models (LLMs) in clinical research, considerations for review and validation of their outputs, privacy and security concerns, regulatory considerations and needs, and ethical concerns.
Meeting attendees discussed the following themes and opportunities for action:
- Generative AI can and should help conduct clinical research. Map the clinical research process in detail to better identify current challenges and the opportunities for AI-informed solutions.
- The critical role of evaluating the effectiveness and impact of AI use cases.
- Trust and transparency must serve as the guiding principles for fostering integrity in innovation.
- Safeguarding the future requires guardrails and universal ethical standards.
- Prioritize collaborative efforts and community engagement.
Directors: Chris Lindsell, PhD, DCRI, Peter J. Embí, MD, MS, Vanderbilt University, and Chuan Hong, PhD, Duke University; Meeting Fellow: Henry Foote, MD, Duke University
Recent Think Tank Publications
Drug Development for Major Chronic Health Conditions–Aligning With Growing Public Health Needs
Lessons from COVID-19 for Pandemic Preparedness: Proceedings From a Multistakeholder Think Tank
"Click and Mortar" Opportunities for Digitization and Consumerism in Trials
Leaders and Partners
The DCRI Think Tanks Advisory Board
Advisory board partnerships with industry leaders help the DCRI Think Tanks program address the right topics, at the right time, with the right people. Our partners provide crucial insight and connections that go beyond DCRI's clinical and operational expertise. From guidance on attendees, framing discussion topics, and contributions to resulting publications, our advisory board members are players in the lifecycle of every event.
