The secret realm of phase I trials in healthy volunteers - Regulators should demand greater transparency

摘要

Phase I clinical trials in healthy volunteers aim to establish safety, pharmacokinetics, and dosage for subsequent testing of new drugs. They are a necessary step in building the evidence for new treatments. But many view them with suspicion. Phase I trials expose humans to unproved drugs—often at plasma concentrations needed for detecting toxicity. Because volunteers are healthy, the ratio of medical risk to benefit for them is almost infinite. Another reason for suspicion is that healthy volunteers are paid—a fact that makes it likely that primary motivations for participation are misaligned with those of researchers,1 and that participants will be drawn from underemployed people.