Do you know what the most valuable asset from your clinical trial is?
On June 12, 2019, the Duke Margolis Center for Health Policy hosted a workshop on analysis data standards. The meeting served as a review of the current status of data standards, voicing the challenges that regulators and the industry face while consuming or implementing analysis data standards.
During the discussions, it was noted that the days of burning your clinical trial data on a CD — only to store it in a pile on a shelf forgotten — are finally over. With the data standardization, storage, analysis, and mining technologies that are available today, your clinical trial data turns into a valuable part of the bigger picture.
Today’s data may be your historic control of tomorrow. It can be used to design new trials and thus reduce the number of patients needed. Or, the data may become part of a data pool, which can be mined across trials or even compounds.
The FDA holds the biggest clinical trial data repository in the world with many use cases. The EORTC RECIST working group, for example, recently analyzed aggregated data from 23,000 oncology patients across 50 Phase II and III studies to further validate the RECIST criteria.
All of this is only possible if we standardize the clinical trial data (i.e., by using CDISC data standards). We will be looking at this topic in more detail in future blog articles.
So, now you know what I think is the biggest asset of your completed clinical trial. I hope you agree.
You can watch a recording of the meeting on the Duke Margolis Center website. (And, yes, I wish I had noticed the camera behind me when I chose my seat. ?)
For more information on how to best take care of your clinical trial data, contact our global clinical analytics team.