Letter in Science: Rethinking Clinical Trials
Phase 1 Studies Insufficient
December 9, 2011
"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
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Questions? Contact the Health Research Group.