A PhUSE Perspective on the 2017 CDISC International Interchange
Scott Bahlavooni , Working Group Director, PhUSE
During the September 2017 PhUSE webinar, CDISC CEO David Bobbitt spoke to a "new day at CDISC". We, at PhUSE, believe the 2017 CDISC International Interchange exemplified this mantra. Shannon Labout, CDISC Interim Chief Standards Officer, delivered a thoughtful, well- received presentation during the plenary session about the ongoing evolution of CDISC. Ms. Labout described the framework for a "new day" that PhUSE believes will be welcomed by standards developers and implementers alike.
Collaboration also permeated the conference. Representatives from the FDA and PMDA spoke to their individual efforts regarding the review of standardized study data. They also discussed ongoing collaborations to harmonize standards implementations between the two agencies. Further, the regulators also recognized the need to continue thinking and acting globally as other organizations such as the China FDA, Medicines & Healthcare products
Regulatory Agency (MHRA) European Medicines Agency (EMA), etc. explore adopting CDISC standards to support regulatory activities.
PhUSE appreciated the opportunity to discuss our collaboration with CDISC in a dedicated Interchange session. Several PhUSE Computational Science working groups discussed projects spoke about their collaborations with CDISC. These projects include supporting SDTM and ADaM implementers, examining new ways of representing anti-drug antibody data in nonclinical research, and defining best practices for CRF completion guidelines. The session also generated ideas for several new collaborations! At PhUSE, we value CDISC participation and leadership within our working groups and look forward to continued joint efforts.