THOUGHT LEADERSHIP

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.

I can actually say that I have been working in the Clinical Trials industry since the last century.  I started as a database programmer, part of data management in a large (now huge) CRO.  In those days we used paper CRFs, entered by hand into a database platform that was built and maintained inhouse.  We had our own naming conventions for variables and could pretty much build whatever we wanted and group the data however it made sense to us.  Prior to deliverables, we printed out the entire database so data managers could review it. All the files were burned to floppy discs and we’d pop them in the mail to the sponsor.  With the amount of data we collect, and the requirement to do more, faster, can you even imagine doing that now?