Comments on the Expedited Investigational New Drug Pilot Program

FDA should require robust conflict-of-interest safeguards, clear eligibility criteria for participating institutions, sponsors, and trials, and measures to protect patient safety before implementing its proposed Expedited Investigational New Drug (IND) Pilot Program, which would allow a small number of third-party “Qualified Research Institutions” (QRIs) to advise sponsors on first-in-human Phase I clinical trial applications. The commenters also discuss lessons from comparable early-phase trial models in China and Australia.