Adam Kroetsch | Clinical Trial Abundance: What it Means, Why We Need It, and How We Get There
Clinical Trial Abundance: What it Means, Why We Need It, and How We Get There
Abstract: In recent decades, drug discovery has been transformed by scientific advances, including AI. But increasingly, our ability to design drugs and generate hypotheses is outpacing our ability to test them. Clinical trials have become the critical bottleneck to medical advances. That's why we are advocating for clinical trial abundance: a focus on making clinical trials cheaper, faster, and more abundant - and more capable of generating useful clinical evidence.
In my talk, I'll discuss the barriers that hold back clinical trial abundance, and how we can address them; including what FDA and policymakers can do. I'll discuss potential reforms to early-phase clinical trials, as well as ways to improve our clinical trial infrastructure and operations in the US. I'll put these proposals for reform in the context of two key developments: the rise of artificial intelligence, and the increasingly important role that China is playing in clinical trials. I'll also talk about drug regulation more broadly: depending on how we design our regulations, they can either hold back innovation or enable it.
Bio: Adam Kroetsch is a senior biotechnology fellow at the Institute for Progress (IFP), a non-partisan think tank focused on innovation policy. For much of his career, Adam has focused on ways to improve our systems for generating and evaluating clinical evidence, including clinical trials and real-world data. Prior to joining IFP, Adam served as a deputy office director at the FDA's Center for Drug Evaluation and Research, at the Duke-Margolis Institute for Health Policy, and at MITRE, a federally funded research and development center. Adam writes about drug regulation and clinical trial policy at the Clinical Trial Abundance Blog and on his personal blog, Policy and Practice.
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Zoom link: https://us02web.zoom.us/j/87184473255