Letter in Science: Rethinking Clinical Trials

Phase 1 Studies Insufficient

“Phase 1 studies are not designed to prove that a drug is safe in healthy individuals, let alone diseased patients for whom the drug is being developed. Indeed, the most important evidence regarding the safety of new drugs is obtained routinely in subsequent phase 2 and 3 trials, which involve many more subjects, longer drug exposure, and much longer follow-up than phase 1 trials,” the letter said. “Grove’s proposal would subject patients on a massive scale to haphazard, uncontrolled, poorly regulated experimentation involving drugs with unknown safety and effectiveness. Such a flawed proposal does not deserve serious consideration.”

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