Quality Oversight In Every Clinical Trial
Today’s clinical trials require quality oversight for one simple reason: sponsors are ultimately responsible for the integrity of the data generated by their third-party vendors. This is most evident in recent FDA warning letters issued to top-quality pharmaceutical firms for failure to oversee the activities of their contract research organizations and other vendors.
Even before reaching warning letter status, problems are attracting the attention of regulatory authorities. FDA investigators are asking how sponsors oversee the activities and assure the quality of work performed by their clinical vendors. Quality oversight answers this question.
A third-party quality oversight program provides an unbiased and objective assessment of the CRO’s work effort. It eliminates the inherent bias that may exist in a long-term relationship between a sponsor and its CRO—a bias that makes it difficult for the sponsor to adequately assess the CRO’s performance.
An optimal quality oversight program provides real-time assessment and reporting of CRO field activity; it is not about co-monitoring or re-auditing, and it is not clinical quality assurance. Rather, it provides a comprehensive assessment of the CRO’s overall process and performance.
Quality oversight is well-aligned with the FDA’s Clinical Trials Transformation Initiative and, as it is accepted as a critical trial process by a large number of firms, will increase its positive impact. It also is aligned with the FDA’s call for industry to be more innovative in its clinical trial work. A trial-specific, formal quality oversight plan could be part of any prospective trial review conducted under the agency’s pilot initiative for adaptive clinical trials.
Most important, a solid, metrics-driven quality oversight report can greatly facilitate the inspection process, particularly when FDA investigators ask “How do you, sponsor, know that the CRO is doing what it is supposed to be doing?”
This article appeared in the October 2011 CenterWatch Monthly.