Some of you may also know remote monitoring of clinical trials as a Risk-Base approach to monitoring. In any event, risk-base monitoring does make many of us a bit uncomfortable including me because we have been taught that the method for evaluating study conduct including protocol compliance, patient safety and data review for each enrolled subject is by conducting frequent on-site monitoring visits. However, if you have worked with academic centers, cooperative groups, and government organizations the practice of on-site monitoring is not really embraced as it is in industry. On-site monitoring every 6 to 8 weeks has been an industry standard for decades, to deviate from the standard does cause a certain degree of stress. The FDA issued a draft guidance http://alturl.com/f6xww last year that certainly encourages Risk-Base Monitoring. The European Medicines Agency and Clinical Trial Transformation Initiative (CTTI) are supportive of the FDA’s approach but my question is, where does industry stand on this issue? I agree that advances in technology, namely electronic data capture (EDC) does allow for risk-base monitoring but is quality at risk? Is subject safety at risk? Will the FDA question/scrutinize a customized monitoring plan The FDA does make mention that risk-base monitoring may not be appropriate for early stage trials (Phase 1) and clinical sites needing more attention, at least the attitude is not “one size fits all”. The FDA has issued a record number of 483s and warning letters in 2010/2011, will risk-base monitoring cause the FDA to be more vigilant and aggressive in their enforcement of the regulations?
The cost savings for industry is staggering. That being said, I am certain that most companies will embrace Risk-Base monitoring but “buyer beware”. It is easy to prioritize the cost savings as # 1 rather than quality or compliance however, I am sure that the FDA will demand 100 percent compliance. In my opinion, a detailed monitoring plan that is followed and of course, updated will be even more critical.