Dr. Marty Makary, head of the FDA, the United States’ drug regulator, announced something genuinely interesting and innovative last week. As Abigail Beaney of Clinical Trials Arena reports:
The US Food and Drug Administration (FDA) is launching a pilot to implement real-time clinical trials (RTCT).
While announcing the pilot, the FDA revealed that two proof-of-concept clinical trials have been successfully initiated, which will report endpoints and data signals to the agency in real time, from AstraZeneca and Amgen.
[…] For each trial, the FDA met with the sponsor on the establishment of criteria for reporting signals in real time. The agency has since received and validated signals for AstraZeneca’s trial through Paradigm Health’s Study Conduct Platform, which automates data collection and analysis while improving how key safety and efficacy signals are reported to both trial sponsors and regulators, supporting more efficient oversight.
We’ve previously discussed Eroom’s law on this blog, which describes the exponential decay of productivity in drug discovery over time. Shortening the time between the conclusion of a trial and the reporting of its results could us realize the potential of AI for drug discovery. Currently, AI is helpful for discovering candidate molecules, but we still have a huge bottleneck in actually testing the resulting experimental therapies in patients. Automated reporting pipelines to regulators could also give us greater confidence in the data if it results in more pre-specification (and less human error/latitude) in data collection and analysis, but that depends on the particulars of how the system is implemented.
Kent Thoelke, founder and CEO of Paradigm Health, said: “This collaboration represents an important step toward expediting how clinical trial data is submitted to and reviewed by the FDA. With Paradigm Health’s platform, clinical trial data can be analysed for key signals in near real time and shared with trial sponsors and the FDA in days, rather than months.
[…]
FDA Commissioner, Dr Marty Makary, said: “For 60 years, we’ve been conducting clinical trials in the same way, where key data signals can take years to reach the FDA. The lag time can delay regulatory decisions unnecessarily and slow down the drug development timeline.”
Obviously, for now, this is all just marketing copy from an AI startup. But I’m excited to see if it works.