Development of a risk-tailored approach and dashboard for efficient management and monitoring of investigator-initiated trials.

ABSTRACT:

Background

Most randomized controlled trials (RCTs) in the academic setting have limited resources for clinical trial management and monitoring. Inefficient conduct of trials was identified as an important source of waste even in well-designed studies. Thoroughly identifying trial-specific risks to enable focussing of monitoring and management efforts on these critical areas during trial conduct may allow for the timely initiation of corrective action and to improve the efficiency of trial conduct. We developed a risk-tailored approach with an initial risk assessment of an individual trial that informs the compilation of monitoring and management procedures in a trial dashboard.

Methods

We performed a literature review to identify risk indicators and trial monitoring approac

SUBMITTER: Klatte K 

PROVIDER: S-EPMC10074803 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature