Summary

The existing framework around modern clinical trials is antiquated and inefficient. The foundations for clinical development date back to the 1938 US Food, Drug, and Cosmetic Act which gave the FDA authority to ensure drug safety. It was later amended by congress—The Kefauver-Harris “Drug Efficacy” Amendment of 1962—which required that drugs be proven efficacious and safe before being sold, and that it was the FDA’s authority to oversee safety and effectiveness was that of the FDA. Now, 40 years later, we’re running clinical trials almost the same way we did when we started.

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Decentralized Clinical Trials: The Call for a New Paradigm