Knowledge, perceptions and practices of risk-based monitoring among clinical practitioners in the United States

Abstract

This study investigated the current knowledge, perceptions, and practices of Risk-Based Monitoring (RBM) using written and verbal responses to an ethics review board approved questionnaire. Responses were collected from individuals involved in the practice, oversight, and implementation of clinical trial monitoring in the USA. RBM was viewed as a positive force with a bright future. However the results suggested that a renewed focus on change management strategies is needed to ensure RBM practices penetrate all levels of clinical trial management. The site sponsor/site operational relationship was identified as a key RBM component. Shortcomings in this relationship were identified as significant operational barriers to effective RBM practice. Respondents indicated that current RBM training efforts were lacking. Because RBM is new and its practices deviate significantly from the past total monitoring efforts, both industry and the clinic need to work harder to ensure that everyone involved in clinical trial monitoring understands these differences. Fortunately, overcoming the identified barriers will not require massive changes to current RBM practice. By refocusing efforts on the sponsor/CRO and investigative sites to attain RBM governance, develop quality control plans, institute an optimal RBM platform, and improve training, the true promise of RBM is within reach. Each of these are critical pieces to an effective RBM implementation methodology and correcting initial stumbles in their implementation can assure the RBM future is as promised.