Medical Review

Medical/clinical reviewers, often called medical officers, are almost exclusively physicians. In rare instances, non-physicians are used as medical officers to evaluate drug data. Medical reviewers are responsible for evaluating the clinical sections of submissions, such as the safety of the clinical protocols in an IND or the results of this testing as submitted in the NDA. Within most divisions, clinical reviewers take the lead role in the IND or NDA review, and are responsible for synthesizing the results of the animal toxicology, human pharmacology and clinical reviews to formulate the overall basis for a recommended agency action on the application.

During the IND review process, the medical reviewer evaluates the clinical trial protocol to determine: (1) if the participants will be protected from unnecessary risks; and (2) if the study design will provide data relevant to the safety and effectiveness of the drug. Under Federal regulations, proposed Phase 1 studies are evaluated almost exclusively for safety reasons. Since the late 1980's, FDA reviewers have been instructed to provide drug sponsors with greater freedom during Phase 1, as long as the investigations do not expose participants to undue risks. In evaluating Phase 2 and 3 investigations, however, FDA reviewers also must ensure that these studies are of sufficient scientific quality to be capable of yielding data that can support marketing approval.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.