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How to Use Real World Data to Generate New Safety Information for Drugs
(Thursday, July 11, 2024) Post-market pharmacovigilance could be improved to collect robust data from the use of products to generate data acceptable to regulatory agencies for new claims for the safety of the products. A new ICH guidance describes various parameters to plan for which would create such robust data. Post-market use is “free” data that could help companies support label revisions for safety. Once a product is approved for commercial sale and is available to the broader market, new information about it becomes available from the clinical use which could provide new insights not feasible with the pre-market clinical trials. While it has been discussed for almost a decade that real-world data could be use for regulatory approval, and there have been a few guidance documents from the FDA, there is still confusion about the specific design of such studies. The new Guidance fills that gap. The detailed guidance describes important aspects such as feasibility assessment, acceptable data sources, target population, the parameters to capture, ways to address bias and confounding factors, data management, and data analysis. Overall, the guidance provides an excellent primer on real world studies. Although the guidance refers to using the information generated for safety updates only, the principles described can be used for efficacy information as well. 
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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