Inspection capacity limitations caused, in part, by globalisation are shifting oversight responsibility from regulators to industry. In this environment the US Food and Drug Administration (FDA), and other regulators, will increasingly expect clinical trial sites to understand and mitigate their risks.
FDA warning letters hint at this new approach, which wants trial sites to take a proactive approach to non-compliance, said Tamera Norton Smith, president and senior consultant of Norton Audits.
Clinical trial sites should understand, and communicate to the FDA, their compliance risks and how they will respond if these events occur. Increasingly the FDA is asking if problems are being responded to in real-time, said Smith.
The next step is self-reporting of compliance events. Smith expects the FDA to make self-reporting mandatory in the future and recommends companies put the system in place before this occurs.
Internal communication must also improve. Companies sometimes fail to effectively use audit information, said Smith, in part because of shortcomings in communicating findings to executive management.
Five failings
By analysing recent feedback from the FDA Smith has identified the five most common compliance issues. The main deficiency is failure to make sure proper monitoring of clinical investigations.
Globalisation of clinical trials makes monitoring more challenging and although companies are spending money on the problem it is often ineffectively used, said Smith. Compliance problems are normally identified by companies, but responses are ineffective
Failure to make sure a trial is conducted in accordance with the general investigational plan and protocol is the second most common problem. This failing is very easy for investigators to spot, said Smith, and can be caused by unrealistic protocols.
The last three common problems are failure to make sure investigators: work in compliance with the study plan and FDA regulations; have the necessary training and experience; and are provided with the information to do the trial.