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.