FDA Expectations for QbD for Clinical Trials
(Thursday, February 8, 2024) The concept of quality by design (QbD) has been used primarily in the context of GMP compliance. However, the FDA expects that this concept should be used in other compliance areas as well, particularly clinical trials. FDA and Duke University recently held a workshop describing various aspects of clinical trials that could be improved by applying principles of QbD. QbD is defined as a systematic approach that begins with a good understanding of the process and design of systems, supported by risk-based quality control. It leads to process improvements, real-time quality control, and a reduction in troubleshooting events. For clinical trials, two FDA guidance documents summarize the QbD approach for clinical trials. The first guidance is on Risk-Based Monitoring (RBM) and the second is the ICH E8 guidance document. The key aspect of QbD for clinical trials is the increased incorporation of patient input into the study design. Patients should be consulted for the design, planning, and conduct of clinical trials in all phases of development. The patient perspective provides a unique perspective on selecting the most appropriate endpoints, populations, and comparators. Less than a third of the sponsors employ Patient Advisory Boards for their trial design. Another factor discussed extensively at the workshop was the important contribution of centralized monitoring and RBM in clinical trial data quality control. Data presented at the workshop showed that about 55% of all clinical trials employ RBM. The biggest barrier to a sponsor from using RBM was lack of awareness with almost 70% of the sponsors claiming this to be the main reason why they did not use RBM. Several other interesting concepts were discussed in the workshop which would be valuable to clinical trial professionals and sponsors alike. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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