Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, the Association of Clinical Research Organizations (ACRO) this week submitted extensive comments on recent FDA Guidance.
Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.
Having surveyed its member companies, ACRO is pleased to report that adoption of RBM tools is growing rapidly. In 2016, less than 20 percent of new trial starts employed some form of RBM oversight. In 2018, a majority of new trial starts were using RBM. 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 E.U regulators.
ACRO’s comments note that the FDA could help increase RBM implementation by articulating stronger and more straightforward support for risk-based monitoring approaches, specifically describing RBM as a “best practice.”
In its comments, ACRO was pleased to include a graphic describing The Risk-Based Monitoring Landscape since 2016. “We look forward to continuing to provide the FDA with unique insights from our member companies,” said ACRO Executive Director, Doug Peddicord. “ACRO members are innovators in the development of RBM technologies. We are pleased to work with sponsors, research sites and the FDA to help ensure the safety of trial participants and the quality of the data submitted for new product approvals.”
About ACRO
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics and medical devices. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ more than 130,000 professionals worldwide and conduct or support the vast majority of clinical trials.
For more information, contact Matt Feldman at [email protected]