THOUGHT LEADERSHIP

At the recent CDISC Europe Interchange in Geneva, I had the honor of presenting the details of a project mapping clinical data into CDISC SDTM, with a twist. It was a small healthy volunteer study run at a single clinic where the site investigator built the data capture system in REDCap. 

This year, PROMETRIKA team members have attended many industry conferences in which the hot topics always seem to be AI and automation of processes. Of course, the innovation cool crowd is excited to jump on board. What has really piqued my attention are the discussions amongst technology vendors about automating SDTM mapping. PROMETRIKA, as a full-service CRO, has a strong focus on biostatistics, statistical, and SDTM programming. Since SDTM mapping is a major part of the programming work that we do, I asked myself “Do we need a new business model for automating SDTM programming?” After hearing multiple viewpoints on the subject, I’ve come away with a list of pros and cons of automating SDTM mapping.

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 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?

Last October, Susan Boquist, Associate Director, Statistical Programming, traveled to CDISC International Interchange in San Diego, California to present the poster, “Creating Harmonious SDTM Domains”.  The poster was created in collaboration with Principal Statistical Programmers: Elena Prosekova, Natalia Quinn and Sofia Tyryshkina. 

Mapping raw data into standardized, tabulated data sets can be a daunting task to undertake, especially if one has not done it before.  Even seasoned mappers could use the help of some additional ideas and tips.  The poster shared the authors’ thoughts, suggestions and examples to help turn a cacophony of raw data into a standardized symphony that will flow into analysis.