NCHR’s Comment on Topics Discussed in the Advancing Premarket Safety Analytics Workshop
December 5, 2022
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We are pleased to have the opportunity to share our views with the Food and Drug Administration (FDA) about topics brought up in the Advancing Premarket Safety Analytics Workshop.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We note that for many years, UK researchers have used grouping systems similar to FMQs known as “Clinical Practice Research Datalink (CPRD) Code Lists” in their clinical trials and observational studies for adverse events as well as possible risk factors. We urge the FDA to discuss what the CPRD has learned about the pros and cons of this system and how the UK has refined this process.
From what we have learned of the CPRD Code Lists and from the Advancing Premarket Safety Analytic Workshop, we support the proposed use of the new FDA Medical Queries (FMQs) for safety assessments for new medications. We believe it would better quantify adverse events and reactions. Shifting the focus from the number of each specific event or overly broad Standardized MedDRA Queries to the number of events that fall under a group of preferred medical terms (FMQ), would focus more attention on adverse events in the safety assessments. Also, having FMQs as the standard for adverse events for new medications could promote easier data exchange, replication, and integration among present and future collaborators.[1] NCHR urges the FDA to ensure that the use of FMQs in clinical trials or labeling should be clearly noted so that providers, patients, and researchers can refer to the FMQ if needed.
Additionally, we agree that the FDA should be transparent in providing their methods for the standard safety tables and figures via their integrated guide to the public. FDA should ensure that these methods “can be reproduced by other researchers in the field, and it helps facilitate proper interpretation and dissemination of results by other stakeholders”.[2] Although these guidelines are not enforceable, we urge the FDA to make these guidelines mandatory so that everyone is held to the same standard.
Thank you for considering our recommendations. If you have any questions, we can be reached at info@center4research.org or (202) 223-4000.
References:
1 Institute of Medicine (US). Sharing Clinical Research Data: Workshop Summary. Washington, DC: National Academies Press (US); 2013. Available from: https://www.ncbi.nlm.nih.gov/books/NBK137818/
2 Kidson, M. The importance of transparency in research reporting. Uoguelph.ca. https://www.uoguelph.ca/hnru/news/2021/10/importance-transparency-research-reporting#:~:text=Research%20reporting%20transparency%20ensures%20that,of%20results%20by%20other%20stakeholders. October 8, 2021