I had the exciting opportunity to attend the 2022 CDISC board meeting and US Interchange virtually last October and present a talk titled “Trace CDISC Application in FDA NDAs and CRs for Clinical Trial Safety.” My presentation was based on a paper written by our team titled, “CDISC Enables Efficient Streamlining of Clinical Trial Safety Evaluation,” which will be published soon in a special CDISC edition of the Journal of the Society for Clinical Data Management. This paper illustrates how CDISC empowers JMP Clinical to help FDA reviewers in their evaluation of drug safety using different JMP Clinical reports on interventions, events, and findings etc.
Earlier this year during the CDISC European Interchange, Dr. Eftychia-Eirini Psarelli of the European Medicines Agency (EMA), announced that JMP Clinical is being evaluated as the only visualization tool for data access and analysis. The whole presentation can be found in Regulatory Presentations, part 1 in CDISC Europe Interchange 2022.
This EMA evaluation builds on JMP Clinical’s strong history of usage by clinical regulatory agencies. Back in September 2011, the FDA announced their evaluation of JMP and JMP Clinical as tools for FDA reviewers in their Assessment of the Impact of the Electronic Submission and Review Environment on the Efficiency and E.... The report indicated JMP 7.0 was already being used by the FDA, and JMP Clinical was under pilot testing by CDER and CBER after only being officially released the previous year. The report also specified the impacts on review processes, data inputs and outputs, and data standards utilized in relationship to other tools for both JMP and JMP Clinical, as well as JMP training courses for reviewers. A few years later, JMP Clinical training courses were also put in place for FDA reviewers.
In April 2018, the FDA revised its Manual of Policies and Procedures for CDER Medical Officer Conversion to Career-Conditional. This document lists required training courses for reviewers to convert “from the medical officer temporary appointment of level 1 (associate reviewer), to the career conditional appointment of level 2 (reviewer).” The required trainings included MedDRA for standardized terminology, Data standards for CDISC, and JMP and JMP Clinical training with multiple models for standard analysis procedures.
In the November 2015 CDISC Interchange, Dr. Yuki Anod of the Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced that PMDA uses JMP and JMP Clinical for common and general analysis for efficacy and safety data. The whole presentation can be found here.
I am proud to have been involved in JMP Clinical’s Research and Development from the very beginning. JMP Clinical is changing the landscape and streamlining the evaluation of clinical trial data quality, safety, and efficacy. JMP and JMP Clinical are used by many regulatory agencies, pharmaceutical companies, CROs and academic institutions for analysis of clinical trial safety and efficacy.
We are now excited to announce the release of JMP Clinical 17, which runs completely in JMP Pro. This new release has much faster performance and interactivity in more standardized presentation formats, while continuing to build on the great lessons and feedback we have received from regulators and customers over the years.
The JMP Life Sciences group, led by Dr. Russ Wolfinger, recently celebrated the latest JMP Clinical release with a trip to Drive Shack (pictured below; a few folks were not able to come). Although we hit some embarrassingly bad shots at times, we had a fantastic time! I look forward to working with my wonderful colleagues to continue improving JMP Clinical.
