In our recent paper, CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation1,2, we followed FDA NDA (New Drug Application) or CR (Clinical Reviews) templates to show how drug safety is evaluated by reviewers at the U.S. FDA. The typical template, shown below, is from an NDA for Mydayis3.
The major content in the safety review can be found in the Safety Results section. Assessing a drug's safety is the primary goal of regulatory agencies when evaluating clinical trials. The first step for any safety review is to examine any deaths or serious adverse events (SAE) that occur during the study to determine if they were caused by the study treatment. Detailed information must be provided on any individuals who died or had an SAE.
In the CR for Latuda4, the reviewer used the Adverse Events Narrative report in JMP Clinical to summarize information for every individual with an SAE. In the AE Narrative report, the first serious adverse event was listed right after the drug dose, as shown below. Next, the narrative captured the subject’s demographics (DM), medical history (MH), discontinuations due to SAE, concomitant medications (CM), and outcome for the event.
It is quite easy to create an Adverse Event Narrative report in JMP Clinical. The following image provides examples of the options for the AE Narrative in the CR for Latuda. The user can choose the AE Narrative template, terms used to refer to subjects, AE categories, and event types for adverse events. The user can also select if the exposure, concomitant medications, medical history, or findings are to be included in the narrative (see below figure). The AE Narrative also has an option to use a Chinese template.
Blog posts in this series:
- New Medical Queries: FMQ and AFMQ Implemented in JMP® Clinical
- Summary of clinical trials using JMP® Clinical
- Safety Results I: Using the Adverse Events Narrative in JMP® Clinical to describe deaths and SAEs
References
- Mann, G. & Pedersen, T. J. & Lyzinski, R. & Scott, A. & Foglia, A. J. & Cromer, J. & Dong, M. & Varga, N. & Gardner, S. & Kirchberg, C. J. & Wingerd, B. A. & Wolfinger, R. D. & Bao, W., (2023) “CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation”, Journal of the Society for Clinical Data Management 3(1). https://doi.org/10.47912/jscdm.169
- CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation published in JSCDM
- NDA Mydayis https://www.fda.gov/media/142063/download
- CR Latada 2018 https://www.fda.gov/media/103749/download
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