The Importance of an Unbiased Safety Review Board in Phase I Clinical Trials

Abstract

Conducting clinical trials is the process that biopharmaceutical companies must use to demonstrate that their product is safe, well-tolerated, and efficacious to obtain marketing approval from the Food and Drug Administration (FDA).1 Human clinical trials are initiated after preclinical trials have demonstrated sufficient safety data. At that point, the FDA will allow these trials to begin on normal healthy volunteers. However, if the FDA considers the risks too high for these volunteers, the agency will require the specific disease population to be studied. For example, the associated adverse effects of many oncology drugs frequently place them into a riskier category, and ethically it would be inappropriate to expose healthy volunteers to these medications. Since many adverse effects
of a drug are not yet known during a Phase I study, they carry an inherent risk to the participants.