WASHINGTON–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/clinicalresearch?src=hash” target=”_blank”gt;#clinicalresearchlt;/agt;–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.
Contacts
Matt Feldman
[email protected]
