Fourth Quarter 2016

Leaders in the fields of biomedical research, regulatory, informatics, patient care and related services gathered at the National Academy of Sciences on 2 August 2016 for a Strategy Session, moderated by Dr. Robert Califf (FDA Commissioner) and me specifically to explore how collaboration, global CDISC standards and related enablers can catalyze more efficient and innovative medical research processes for the benefit of all.  While the adoption of electronic health records continues to increase, there is still a need for interoperability among them and improved alignment with research.

After 20 years in existence, one would think that the answer to the question “What is CDISC?” would be obvious, but even yesterday I was trying to explain this to an audience at the Taipei Medical University.  Many of our Leadership Team Members have had the opportunity to travel in October and November, and much of this involved invitations and travel support to present CDISC to new audiences or to work with new colleagues on projects that would benefit from CDISC.  I have also read with interest the report from the ‘Blue Ribbon Panel’ for the Cancer Moonshot, a draft position statement on data sharing by the Coordinated Research Infrastructures Building Enduring Life-science Services (CORBEL) and recommendations by Patient-Centered Outcomes Research Institute (PCORI) around data sharing and reports on panels at Partnering for Cures. Unfortunately, although data standards are critical to each of these efforts, it seems that the “S” word is either “off limits” or not clearly understood….or both. Our work to communicate about CDISC and the value of standards in research is not done; and, in fact, it becomes more important and urgent each day as increasing amounts of data are generated at an increasingly more rapid pace.

CDISC, in collaboration with a variety of stakeholders, is developing Therapeutic Area (TA) standards through the Coalition for Accelerating Standards and Therapies (CFAST) initiative. TA Standards extend existing CDISC standard metadata to include disease-specific metadata, examples and guidance on implementing standards for a variety of uses, including global regulatory submissions. To date, CDISC has developed TA standards for over 25 indications.

In September, E3C held the first of two face-to-face meetings to prepare for the 2017 CDISC Europe Interchange in London, headquarters of the Europe Medicines Agency (EMA). EMA Chief Scientific Medical Officer Dr. Hans-Georg Eichler will deliver the keynote speech at the CDISC Europe Interchange the last week in April. We anticipate additional involvement and updates from EMA, as they continue to increase their support for CDISC standards. Representatives from FDA and PMDA will also be in attendance.

Hidetoshi Misawa (Pfizer Japan Inc.) chaired a session titled “Impact to NDA Preparation and Approval Review by Initiation of the Submitted Electronic Data” at the 2016 DIA Japan Annual Meeting in November. With the PMDA now accepting the submission and review of electronic study data, differences between PMDA and FDA requirements for electronically submitted study data have arisen, making it necessary for some companies to convert past study data into this electronic submission format.