Crowdsourcing Clinical Trials

The article identifies a fundamental ethical flaw in pharmaceutical regulation: newly FDA-approved drugs are effectively “tested” on an unknowing general public in the months and years after approval, due to the inherent inability of even the largest preapproval clinical trials to detect rare adverse events. The author proposes a “crowdsourcing” framework to improve post-approval drug surveillance, addressing the gap between the limited safety data available at the time of FDA approval and the full risk profile that only emerges through widespread clinical use.