'CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation' published in JSCDM

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In 2022, CDISC initiated a project with the Journal of the Society of Clinical Data Management (JSCDM) to create a library of peer-reviewed articles focused on the implementation of CDISC standards. More than 30 abstracts were received and, as of today, a total of 15 articles have been published and another four are nearing publication. 

Prior to this effort there were few, if any, articles in the literature that directly dealt with implementing CDISC standards. To address this unmet need, Rhonda Facile, Vice President of Partnerships and Development at CDISC, led the effort to create the first CDISC special issue in JSCDM. A highlight of the first issue are articles from three different regulatory agencies: the U.S. Food and Drug Administration (FDA), Japan's Pharmaceutical and Medical Device Agency (PMDA), and the Danish Medicines Agency (DMA). 

The JMP Clinical team is proud to have contributed one of the first 15 articles in this special issue, one which outlines the importance and application of CDISC. Our paper, CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation,¹ can be downloaded from https://www.jscdm.org/article/id/169/.

In our paper, we demonstrate how drug safety can be evaluated by JMP^® Clinical, following the FDA New Drug Application (NDA) and Clinical Review (CR) templates. We reproduced figures and tables in multiple NDAs and CRs that were clearly labeled to be generated by JMP Clinical or JMP in our paper by using JMP Clinical sample data. The FDA NDA template example is shown in the middle of the figure below and is surrounded by JMP Clinical figures and tables illustrating how the drug safety evaluation could be presented according to the multiple real NDAs and CRs. 

Many of my talented JMP colleagues who have made great contributions to the success of JMP Clinical are the co-authors of the paper. We are very grateful for the suggestions and editing provided by Rhonda Facile and Melissa Kirwin of CDISC, as well as Dr. Meredith Nahm Zozus, editor of the JSCDM.

My first blog, JMP Clinical Recognized Internationally by Regulatory Agencies², is part of this paper. In future blogs, I will share some of the details of this paper.

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. JMP Clinical Recognized Internationally by Regulatory Agencies Feb, 2023 https://community.jmp.com/t5/JMP-Blog/JMP-Clinical-Recognized-Internationally-by-Regulatory-Agencies...