Site Principal Investigators in Multicenter Clinical Trials

The success or failure of multicenter clinical trials will remain dependent in large part on the engagement of the site principal investigator (PI). Site PIs play an important role in trial selection, site activation, and study execution, including the development and implementation of a strategy to maximize enrollment, optimize data quality, and ensure patient retention. It is notable that the legal, regulatory, financial, and workload burden for site PIs has grown considerably over time (Figure).1 In contrast, the benefits for serving as a site PI have become less evident. As a result, increasing dissatisfaction exists among physicians involved as site PIs in multicenter trials and there is less interest in trial participation. In this article, we outline current responsibilities and challenges faced by the site PI and propose new strategies to improve the engagement and recognition of site investigators moving forward. Figure. Legal and operational activities traditionally associated with site PIs1 and potential strategies to improve the engagement and recognition of site investigators. CME indicates continuing medical education; MOC, maintenance of certification; and PI, principal investigator. The roles and responsibilities of site PIs in a large clinical trial relative to those of the trial’s overall study leadership can be likened to the stage crew and principle actors in a theater production. The stage crew spends hours with set preparation and the logistics of production, which ultimately the actors will benefit from and receive recognition for. Similarly, the site PIs and their research team identify and recruit patients, conduct study procedures, complete necessary study documentation/reporting, and retain patients for outcomes assessments. However, the overall trial leadership most commonly reports the major trial results and receives national and international recognition. Specific examples of the workload of the clinical …