The role of nurse practitioners as principal investigators for clinical studies.
Nurse practitioners (NPs) are ideally suited to assume roles of principal investigators (PIs) in clinical trials. NPs are trained and authorized to perform physical examinations, make clinical assessments, diagnose and treat diseases, and prescribe drugs, either independently or in collaboration with a physician. In addition, since they often collaborate with physicians in the delivery of primary care, sponsors would effectively be reaching both NP and physician prescribers concurrently. Sponsors currently rely on approximately 30,000 clinical investigators to enroll subjects in clinical trials. If only 10% of the 71,000 NPs in the US could assume the authority of PIs, it would effectively increase the PI pool by 25%. This paper examines the advantages and rationale of using NPs as PIs in select clinical trials.
