FDA's New Guidance On Clinical Monitoring Arrives

By Jacquie Wiebe Mardell

The FDA has released its long awaited update and replacement to the outdated 1988 guidance on clinical monitoring. The draft guidance for industry on Oversight of Clinical Investigations - A Risk Based Approach to Monitoring is early evidence that the findings and recommendations of the Clinical Trials Transformation Initiative (CTTI), FDA's public-private partnership with Duke University among others, are beginning to take hold in practice in the clinical trials domain.

According to a CTTI survey, clinical trial sponsors are successfully employing a range of monitoring modalities, such as centralized monitoring by biostatistical and data management personnel, targeted on-site visits to higher risk sites as well as frequent on site visits to all sites by clinical monitoring personnel. Yet historically, industry sponsors have rarely relied on any mechanism other than comprehensive all-site monitoring performing 100% source data verification, every four to six weeks. It is a well-understood, costly and time consuming method of monitoring that the industry perceives is preferred by FDA. Yet, given the vast changes in the clinical trial landscape in the decades since the FDA's previous 1988 guidance and the regulations covering sponsor obligations, including the increase in the number and complexity of clinical trials, investigator experience, changes in ethical oversight, treatment options, and geographical dispersion of clinical trial sites, the FDA now calls on the industry to employ new and more effective methods for monitoring clinical trials.