A national registry for healthy volunteers in phase 1 clinical trials.

摘要

A significant risk of participating in a phase 1 drag trial is the possibility of a dangerous interaction between an inves-tigational agent and another medication the participant is currently taking or has taken recendy.3 This risk is especially great in phase 1 studies designed to induce toxicity to determine the maximum tolerable dose.3 Also, recent participation in another study can skew safety data. Most investigators minimize risks and reduce bias by excluding volunteers from phase 1 drug studies who have recently participated in another phase 1 trial. In the United States, the standard interval is 30 days.3 Although most drugs are eliminated from the body sooner than this, the 30-day interval is a standard safety measure, because some individuals may metabolize or eliminate drugs more slowly than others. Ideally, the protocol should specify an appropriate waiting period based on the half-life of the test agent, because in some cases, the interval may need to be longer than 30 days.