Summary of clinical trials using JMP® Clinical

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Before we can understand clinical trial data in detail, we need to understand the protocol or trial design to get a big picture of the clinical trial data. This data can be described in three ways: trial, event, and treatment emergent adverse events (TEAE) summaries, as explained in our recent paper CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation^1,2.

1. Trial summaries can be described using the Study Flow Diagram report in JMP Clinical to understand the flow of subjects through the various steps of a trial. The diagram of the Nicardipine trial, shown below, starts with 906 subjects assessed for eligibility. Four subjects failed preliminary screening according to the data in the DM domain. The 902 remaining subjects were randomized and divided into two treatment groups. Based on the DS domain, protocol information for disposition events and epochs (e.g., on-treatment and follow-up) are presented from the study: 447 subjects in the treatment group (NIC. 15) and 455 subjects in the placebo group. Both treatment and placebo groups have similar denominators among the disposition events: completed (357 and 363); death (80 and 81) and lost to follow-up (10 and 11) and are shown in the flow diagram below.

2. An event summary is generated by the Event Distribution report in JMP Clinical, which compares the subject number and percentage for each group,  as well as the totals, for each disposition event, along with typical disposition events such as randomized, completed, and lost to follow-up, as well as the Date of SAH, and Glasgow Outcome Scale categories: recovery, death, moderately disabled, severely disabled, and vegetative survival.

3. The Treatment Emergent Adverse Events Summary report created by JMP Clinical identifies whether adverse events occurred on or after the date that the intervention or treatment began, which is very important for clinical trials. This report lists the number and percent of subjects in the treatment groups for any TEAE, severe TEAE, emergent SAE, TEAEs leading to death, and discontinuation according to the AE domain, as shown in the table and bar plot formats.

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

1. 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
2. CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation published in JSCDM