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

Objective: To quantify the frequency and seriousness of adverse events in non-oncology phase I studies with healthy participants.

Design: Meta-analysis of individual, healthy volunteer level data.

Setting: Phase I studies with healthy volunteers conducted between September 2004 and March 2011 at Pfizer's three dedicated phase I testing sites in Belgium, Singapore, and the United States.