Risk-Based Monitoring: Barriers to Adoption.

This 2018 survey findings showed that approximately two thirds of sponsor respondents and three quarters of CROs have adopted some type of RBM. Small pharma/biotech and small CROs were the main organizations that have not adopted RBM in the five years since the 2013 FDA and European Medicines Agency (EMA) releases of recommendations for adopting a risk-based approach to monitoring, m A wide variety of implementation approaches have been adopted, with varying ability to detect "errors that matter." A significant, unmet medical need exists to test and publish data to determine the effectiveness of the different RBM implementation approaches. This would help the industry make informed decisions about how to best protect study participants' safety and obtain scientifically valid data to support the delivery of new medicines for patients. [ABSTRACT FROM AUTHOR]