Did you find yourself breathing a sigh of relief at some point in the past year, thinking all the hullabaloo over the theories and practices of risk-based monitoring (RBM) and risk management in the clinical research enterprise had finally died down? Think again. Signs of ongoing concerns over the proper roles and execution of the two related concepts in medical research and development are creeping back into the light, judging by recent news items and recent and upcoming presentations.
Commenting on a 2019 U.S. Food and Drug Administration (FDA) draft guidance on RBM, the Association of Clinical Research Organizations (ACRO) announced that a survey of its member companies had found that “adoption of RBM tools is growing rapidly. In 2016, less than 20% of new trial starts employed some form of RBM oversight. In 2018, a majority of new trial starts were using RBM.” However, ACRO went on to note, “Challenges to implementation of RBM remain, including perceptions that traditional oversight methods are lower risk and less subject to critical scrutiny by U.S. and EU regulators.”
ACRO feels “FDA could help increase RBM implementation by articulating stronger and more straightforward support for [RBM] approaches,” specifically by describing RBM as a “best practice.”
Meanwhile, a public meeting to be hosted by Duke University’s Margolis Center for Health Policy on July 17 in Washington, D.C. under a cooperative agreement with the FDA will focus on the current state and hoped-for future of RBM in clinical investigations. One panel session will feature Jonathan Andrus, chief business officer at Clinical Ink, Ann Meeker-O’Connell, vice president and global head for quality assurance at IQVIA, and Mike Henderson, senior manager in health and life sciences industry analytics at SAS, exploring available analytic approaches, technology, and tools that could support the implementation of RBM.
“Understanding why RBM approaches have not been widely adopted and what can be done to encourage their use will benefit the entire global pharma and biotech industry,” says Andrus.
The public workshop aims “to capture stakeholder input on the challenges, barriers, and enablers to implementation of RBM,” according to information on the Margolis Center’s website. “This workshop also will consider stakeholder experiences with RBM adoption and opportunities to improve the implementation of RBM.”
While RBM was often part of the mix of broader conversations at the recent ACRP 2019 meeting in Nashville, multiple speakers tackled associated risk management topics directly, including in the following sessions, recordings of which are available to ACRP members in the Online Conference Library:
- Susan Leister, MBA, PhD, CQA, CSSBB, presented “Risk Management, the Crash Course,” to help prepare listeners for the risk management requirements of the updates found in the ICH GCP E6(R2) guideline on Good Clinical Practice from the International Council for Harmonization.
- Suheila Abdul-Karrim, CCRA, CCRT, FACRP, CSci, and Victor Chen, MSc, presented “A Five Step Approach to Device Risk Management” to highlight risk management as an integral part of the medical device product development lifecycle.
- Jessica Saunders, MACPR, Sally Jo Zuspan, RN, MSN, and Melissa Metheny, RN, CCRC, presented “Risky Business: Impact of a Risk-Based, Study-Specific Training Program on Research Coordinator Competency in an Emergency Department Setting” to focus on three important steps to assure research coordinators’ competencies in study procedures at the beginning of a trial: risk assessment, development of a competency-based training program, and implementation of that program.
Author: Gary Cramer