Quantifying the risks of non-oncology phase I research in healthy volunteers: meta-analysis of phase I studies

摘要

STUDY QUESTION How common and serious are adverse events in phase I trials involving healthy volunteers? SUMMARY ANSWER Serious adverse events are rare in phase I studies with healthy volunteers. In a meta-analysis of 11028 participants who received study drugs, 34 (0.31%) serious adverse events occurred and there were no deaths or life threatening events. WHAT IS KNOWN AND WHATTHIS PAPER ADDS A key ethical concern about phase I research with healthy volunteers is that it exposes healthy individuals to serious risks for no clinical benefit. We found that half of the serious adverse events were not related to the study drug or a research procedure, and 84% of all adverse events were mild and 1% severe.