THOUGHT LEADERSHIP

The annual CDISC US Interchange conference is an opportunity for PROMETRIKA’s Statistical Programming team to learn about the newest ideas and trends for data dissemination in the industry. At this year’s gathering, between the keynote speaker’s sentiments, the FDA’s opening thoughts, and the breakout sessions – one idea carried through each talk; how do we increase communication and collaboration across all functions to make everyone’s life easier and reduce the work load placed on all involved – from Sponsors to CROs to the FDA to patients?

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.

In a CRO environment, managing Data Management programming requests presents significant challenges, including prioritization, resource planning, and timely delivery of results. There are a set of recurring tasks, coming from multiple sponsors, with varying frequencies and updates needed. Programmers need a way to keep these tasks organized and to optimize the work flow.

PROMETRIKA’s statistical programming team is developing methods to enhance the efficiency and maintain high quality of table development while managing changes in the data and the requirements as table programming is in progress.