Evaluation of risk-based monitoring in investigator-initiated trials and outlining the role for centralized monitoring

Many recommendations on the appropriate approach to risk-based monitoring have been issued, but evidence on their effectiveness with respect to data integrity, patient safety, and overall clinical trial quality is scarce and scattered. In addition, how to best implement a risk-based monitoring approach with automated centralized components remains unclear. We therefore conduct (I) a Cochrane systematic review summarizing the available evidence from controlled studies on different monitoring strategies, and (ii) an implementation study at the clinical trial unit Basel using mixed methods.

Basel research team
Katharina Klatte, Pascal Benkert, Alexandra Schulz Klaus Ehrlich, Marie Mi Bonde Hansen, Christiane Pauli-Magnus, Matthias Briel