Sponsors often rely on Standardized MedDRA Queries (SMQs) to group adverse events for detection of safety signals across clinical trials. Additionally, the FDA has introduced their own version of adverse event groupings – FDA MedDRA Queries (FMQs). So, what’s the difference?
To start, our understanding is that FDA’s intent in publishing FMQs was just to provide transparency into the AE groupings they use when reviewing data. At this time, there is no regulatory expectation that sponsors will use FMQs in their safety analyses.
That being said, our general goal in developing safety analyses is to determine if any safety signals exist so that we can develop a mitigation plan. If the agency uses these new FMQs in signal detection, wouldn’t it be logical for us to perform those same analyses before submitting our marketing application?
Our recommendation is to maintain the existing process that relies primarily on SMQs, but to also use the FMQs for internal exploration. There are an overwhelming number of FMQs (104, to be exact), so it doesn’t make sense to discuss them all in the submission. We suggest running analyses internally on all FMQs, and if any of these groupings turns up a disproportionate number of events in the investigational arm, then we prepare a more targeted analysis/discussion.
Questions about MedDRA queries? Contact us to speak with one of our Biometrics Regulatory Experts.
Evan Zucker, Principal Biostatistician, has 8 years of experience providing statistical support for clinical trials, with a specific focus on late-stage regulatory submissions. Mr. Zucker has supported upwards of twenty marketing applications and over a dozen FDA meetings, often working as the primary author of integrated statistical analysis plans and CDISC-compliant integrated analysis dataset (ADaM) specifications for the ISS and ISE. In supporting marketing application submissions, he also acts as a data standards expert, reviewing and updating study data packages to ensure compliance with the latest FDA requirements, technical rejection criteria, and CDISC/legacy guidelines. Mr. Zucker has collaborated with clinical researchers and medical authors across various therapeutic areas, including pain/anesthesia, psychiatry, otolaryngology, oncology, ophthalmology, rare/genetic diseases, and vaccines/infectious diseases.