Are clinical trials safe?
Clinical trials are among the most rigorously safety-monitored activities in medicine. Every trial must be reviewed and approved by an Institutional Review Board (IRB) — an independent ethics committee — before a single participant is enrolled. The IRB scrutinizes the protocol, the informed consent document, and the risk-benefit analysis to ensure participant safety. During the trial, an independent Data Safety Monitoring Board (DSMB) reviews safety data on a rolling basis and can halt the study at any time if risks emerge. The FDA can also halt trials. You'll undergo a thorough screening before enrollment to confirm the study is safe for you specifically, you'll be monitored closely throughout, and any adverse event — even one possibly unrelated to the study drug — is reported and tracked. That said, no medical intervention is risk-free. The informed consent form lists known and possible side effects in plain language so you can decide whether to proceed.