FDA Issues Final Guidance on Clinical Trial Oversight

The FDA released its final guidance governing clinical trial oversight and urges a risk-based approach to monitoring. The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods. The guidance provides various risk-based monitoring strategies and clarifies that while the Sponsor can transfer monitoring responsibilities to contract research organizations (CROs), the CROs should be regularly monitored for their compliance to regulations.

As an initial priority of the BIO Clinical Trials Modernization Initiative, BIO is committed to working with member companies and other stakeholders to advance risk-based approaches to monitoring.  Accordingly, BIO has engaged the leadership of TransCelerate BioPharma, which recently published a position paper on risk-based monitoring (RBM) methodology that is now being piloted in the clinic.  BIO is working with TransCelerate BioPharma to raise awareness of the RBM methodology and pilot amongst BIO member companies.

Moving from resource-intensive, on-site monitoring approaches toward remote, risk-based monitoring represents an important step in realizing greater efficiency and quality in clinical research.

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