THOUGHT LEADERSHIP

As a CDISC Platinum Member, PROMETRIKA has the opportunity to sit on the CDISC Advisory Council (CAC), which plays an important role in shaping CDISC’s development and direction. Platinum Member representatives serve on the CAC, contributing industry expertise and sharing real-world implementation experiences. The CAC represents a cross-section of organizations within the pharma industry; thus, making them a part of the review process for assessing and revising standards. Collectively, the CAC provides the CDISC Executive Team with recommendations that further the CAC mission of “unifying the voices of membership to influence and support CDISC goals.”

The accurate analysis and reporting of data is necessary to the evaluation of new treatments for human diseases. Regulatory authorities must weigh the risks with the benefits of treatments in their approval decisions. Often, regulators will ask sponsors to provide information about the analyses, such as the datasets and data selection criteria used to generate the results. The Clinical Data Interchange Standards Consortium (CDISC) has described their newest initiative to standardize analysis results in the form of tables, listings, and figures (TLF) and reporting of data across the industry.

CDISC standards in clinical trials are the cornerstone of any successful submission to regulatory agencies. While they are “standards,” the structure and the nuances of applying them are continually evolving and changing, making it important to keep up to date in order to provide quality submissions. Here at PROMETRIKA, a full-service CRO, our statistical programmers and biostatisticians engage in continuing education activities by attending webinars, conferences, and training sessions specifically related to CDISC standards in clinical trials.

I had the opportunity to attend the 2023 PHUSE conference and explore the latest advancements in clinical data analysis through engaging workshops and presentations. Key topics included CDISC Analysis Results Standards, SDTM mapping recommendation engines, incremental automation using machine learning, and Leadership and professional development. The conference provided valuable insights into emerging trends and technologies that are shaping the future of clinical research.

In any industry, there are various methods for approaching task deadlines to remain within the timeline. It is vital to choose a method that can accommodate challenges faced during the project and reduce time or at least help mitigate any delays. Effective task management is the key to maintaining the project budget and addressing other challenges.