If the best way to know whether a medicine is effective is through a clinical trial, then where does (and doesn’t) real-world data and real-world evidence come in? The topic is always top of mind in drug development, with additional focus as of 2016 thanks to the 21st Century Cures Act — but is especially heated lately given recent concerns and claims around particular drugs in the context of the novel coronavirus pandemic.
So in this short-but-deep dive episode of 16 Minutes on the News, a16z general partner in bio Vijay Pande — previously a professor of Chemistry, Structural Biology, and Computer Science at Stanford University (as well as founder of [email protected]) — breaks down the debate between RWE vs. RCT (real world evidence and randomized controlled trials), in conversation with Sonal Chokshi. Is it a tradeoff between speed of innovation and safety, or is it a false dichotomy altogether? Where do and don’t statistics come in when it comes to policy? How has, and could, the role of the FDA (as well as payers reimbursing healthcare) evolve here? And where can technology help?