The US Food and Drug Administration (FDA) recently expanded on its recommendations for taking risk-based approaches to clinical trial monitoring in a new draft guidance.
Structured as a question and answer (Q&A), the document builds on the agency’s risk-based monitoring (RBM) guidance and was open for comment until May 14, 2019.
Responding, the Association of Clinical Research Organizations (ACRO) submitted comments on the recent draft guidance, calling on the FDA to describe RBM as a “best practice,” among other proposed changes. “ACRO believes that a stronger statement about the place of risk-based monitoring in the oversight toolbox would be useful,” the comment reads.
ACRO also noted that the guidance does not resolve questions about the definition of central monitoring.
Others commented as well, including Bristol-Myers Squibb (BMS) and Pfizer, which raised areas where it said the industry would benefit from additional clarification. This included inspections, identifying risk to good clinical practice, and measuring success of a risk-based approach.
Pfizer suggested working with the Clinical Trials Transformation Initiative (CTTI) to collect data “to determine whether the factors noted as potentially important are important to quality outcomes.”
RBM adoption rates
ACRO Executive Director, Doug Peddicord told us, “Sponsors and CROs are committed to risk-based approaches to trial design and monitoring planning, and at this point always include risk-based principles in their planning.”
In line with this, ACRO recently surveyed its members regarding their RBM processes and implementation and found that adoption is accelerating.
Per the report, less than 20% of new trial starts employed some form of RBM oversight in 2016 – the year ICH E6 (R2) was issued, encouraging the use of RBM, which Peddicord said helped drive penetration.
By 2018, the majority of new trial starts were using RBM (61%), according to the survey. Still, challenges remain, including the perceived notion that traditional oversight methods are lower risk and less subject to regulator scrutiny.
“All of us – sponsors, CROs, technology companies, research sites, IRBs – hope that increasing adoption of technology-enabled tools will, over time, reduce some of the burdens of participation for patients and investigators alike,” said Peddicord.
