Pharmacists as investigators in FDA-regulated drug trials

Abstract

Regulatory approval of medications to be marketed in the United States by the Food and Drug Administration (FDA) generally follows a very prescriptive process that can take on average 8.5 years.1 For certain drugs that meet FDA’s criteria for fast-track approval, a parallel track-policy permits clinicians to obtain investigational drugs for HIV- or AIDs-related diseases through expanded-access protocols (EAPs). EAPs require institutional review board (IRB) approval and the informed consent of participating patients. The sponsor requires the completion of FDA form 1572, a legally binding contract delineating specific roles and responsibilities for each member of the research team, by the investigators participating in EAPs. The investigators are responsible for the conduct of a clinical trial at a given site, and the principal investigator is the team leader. Historically, pharmacists have been involved in FDA-regulated research primarily as research or investigational drug pharmacists. These pharmacists play a vital role in the procurement, storage, record keeping, preparation, and dispensing of medications to study subjects. However, the expanding clinical role of pharmacists provides an opportunity for participation in FDA-regulated drug trials as principal investigators or subinvestigators.