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FDA Suggests Selected Safety Data Collection But Sponsors May Find It Hard
(Thursday, May 2, 2024) A new guidance document released this week encourages sponsors of Phase 3 and post-market clinical trials to consider selective safety data collection (SSDC) whereby safety data is limited to major adverse events. The guidance will be hard to follow by the sponsors who are used to collecting detailed safety data in all trials, but does provide a way for those interested. Detecting and investigating adverse events related to an investigational product is the core requirement for all clinical trials. Over the last century, it has been drilled into all clinical trial professionals to pay attention to all adverse events in a clinical trial irrespective of their severity and seriousness. In clinical trials, sponsors collect extensive safety-related data that may include vital signs and other physical examination data, laboratory data, and all adverse events. So, telling them to not collect some adverse events in clinical trials seems counter-intuitive. The new guidance describes that SSDC can be implemented when the safety profile of the investigational drug is well-understood and documented such as for trials designed to find new uses of previously approved products or post-market trials where the safety profile of the drug has already been established in the pre-approval trials and the intent of the new trial is to collect new adverse events not previously seen or expected. The guidance advises that the sponsors should consider mechanistic factors, previous clinical safety database, similarity of the planned clinical trial to previous trials, clinical pharmacology, non-clinical data, and other data when considering SSDC. The patient safety can never be compromised. Serious adverse events, important medical events, medication errors or overdoses, adverse events that led to study drug discontinuation in a participant, pregnancy and lactation exposure and outcomes, and adverse events of special interest, including laboratory abnormalities, should always be collected. SSDC can be used to limit collection of nonserious adverse events, certain laboratory monitoring, physical examinations and vital sign data, and changes in concomitant therapies post-baseline measurements. The guidance acknowledges that SSDC may not be easy to implement and have unintended consequences. “The use of SSDC may present complexities for data analysis, presentation, and summarization. Some questions that may arise retrospectively cannot be explored if the data were never collected, e.g., issues concerning concomitant medications, laboratory parameters, blood pressure.” It is strongly recommended that sponsors discuss their plans for SSDC with the FDA and get an agreement before implementing. It is never easy to change the established standards and practices. This guidance document intends the sponsors to think differently about safety. But in the process, it also emphasizes the challenges of that approach. Most sponsors may find it easier and less risky to collect safety data in their trials conventionally. We will wait to see if SSDC is adopted by the wider trial community or becomes a niche process. 
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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