Real-Time Trial Review Needs a Response Plan, Not Just a Data Feed

When the FDA announced recently that two drug companies had begun streaming clinical trial data to agency reviewers in real time, FDA Commissioner Marty Makary, MD, MPH, reached for an analogy from his own training. As a surgical oncologist, he watched his patients in the operating room and ICU on continuous monitors. When vitals dropped, the team intervened. Nobody waited for a report in the mail. Why, he asked, should regulatory oversight of experimental drugs be any different? It's a good analogy. It also gives away more than the announcement intends. Real-time data is not the same thing as real-time oversight. A monitor that beeps in an empty hospital hallway is not a clinical safeguard, and a data feed that arrives at FDA without a defined plan for who acts on it, when, and how is not regulatory review. The challenge in continuous monitoring has never been getting the data. It has been deciding what to do about it. The announcement describes, in detail, a system that delivers signals faster. But right now, it says little about what happens when one arrives. That gap is something we should be watching as this initiative evolves. We have spent decades learning what