Risk-Based Monitoring: Barriers to Adoption

• Published in: Applied clinical trials Vol. 27; no. 12; pp. 22 - 24
• Main Author: Manasco, Penelope K
• Format: Journal Article
• Language: English
• Published: Monmouth Junction MultiMedia Healthcare Inc 01.12.2018
• Subjects: Best practice; Biotechnology industry; Clinical trials; Corporate sponsorship; Executives; Methods; Technology adoption; Vaccines
• ISSN: 1064-8542; 2150-623X

For those companies that have adopted RBM, the most common challenges to implementing RBM include (with number of respondents): * Having the technology tools work together is difficult (9) * Trainings must be designed for all team members (8) * Monitor resistance to RBM (7) * Difficult to understand the different RBM approaches (7) * Skills for monitors are different (6) * Skills for project managers are different (6) * SOPs are not written for new approach (6) * Senior management does not understand the process differences (6) * Difficult to choose which approach is best for our organization (6) * Technology tools are confusing, difficult to know which are needed (6) * Operational metrics are different (5) Outcomes Table 1 illustrates the outcomes reported from implementing RBM. Discussion The variability in RBM definitions and RBM implementation approaches was surprising and listed as one of the two most common barriers to adopting RBM. Since each RBM approach will have varying ability to detect "errors that matter," this complicates the discussion of implementation and outcomes from RBM. [...]the more than 33 complete response letters from January 2017 to May 2018 also support the fact that previous successes from unproven monitoring methods do not indicate continued success.6 Applied Clinical Trials recently published the first head-to-head comparison between traditional SDV and one method of RBM (i.e., the MANA Method), showing superiority of the RBM approach.7 We hope this first article to address the subject will be one of many publications that uses data to evaluate the effectiveness of different oversight methods. [...]supporting the research and publication of data-driven comparisons of different oversight methods will help the industry adopt proven oversight methods.