Certification in good clinical practice and clinical trial quality: A retrospective analysis of protocol adherence in four multicenter trials in the USA

Abstract

Background: The value of training in Good Clinical Practice (GCP) for clinical research professionals is unknown. The objective of this study was to assess the impact of formal training in GCP on the quality of clinical trials. Methods: Retrospective analysis of data collected from four multicenter trials conducted in the US in 2008. Certification as Physician Investigator (CPI) or Clinical Research Coordinator (CCRC) was used as proof of formal training in GCP. Protocol adherence was used as a proxy for the quality of clinical trials and quantified by the number of protocol deviations. The primary variable for analysis was the number of protocol deviations per randomized subject and site. Results: A total of 1,418 subjects were randomized by 101 investigators (29% CPI) and 109 clinical research coordinators (29% CCRC), with 520 protocol deviations. Compared to “no certification”, the Odds Ratios (OR) for the incidence of protocol deviations were OR = 1.20 (95% Confidence Interval [0.852–1.688]; p NS) for “CCRC-only”, OR = 0.70 ([0.513–0.953]; p = 0.0256) for “CPI-only”, and OR = 0.37 ([0.273–0.507]; p < 0.0001) for “CCRC + CPI”. Conclusions: This pilot study showed that formal training in GCP has the potential to improve protocol adherence and clinical trial quality.