FDA and MHRA hosted a joint workshop on data integrity issues in GCP trials this week that described several interesting trends in US and non-US trials. The most common deficiency (61%) in GCP was due to the investigators failing to follow the clinical protocol, followed by inadequate and incomplete records (29%). Inadequate drug accountability was a bigger issue in non-US sites (14%) compared to US sites (7%). Similarly, non-US sites had about twice as many informed consent issues than US sites; 8% at non-US sites, compared to 4% at the US sites. Overall, both regulators have seen similar trends with the use of eCRF, eTMF, and electronic medical records. For example, both regulators found security and integrity issues (where data was changed improperly) with electronic data albeit to an extent of 3-5% findings meaning that these issues should have minimal impact on overall conclusions of the trials. The most common deficiency from sponsors was inadequate monitoring, lack of enforcement of the protocol, and inadequate and inaccurate records. MHRA inspectors observed that 96% of the data issues at the clinical sites were hidden by the study staff from the senior management at the sites where the staff tried to correct the errors without letting the senior management such as PI know about it. The regulators recommended that clinical sites pursue internationally recognized quality standards such as ISO 9000, 9001 and 9004 for their quality management system, and also apply the principles of Quality by Design and Risk-Based Thinking in clinical trial projects. Overall the Data Integrity workshop provided a unique regulatory perspective of practical aspects of GCP and listed several tips to achieve high quality clinical trials. The advice is potentially beneficial to all levels of experts in GCP.
Three Essential Takeaways from the FDA’s Latest ESTAR for PMA Submissions
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