CDISC Blog

I attended the Coalition Against Major Disease (CAMD) Coordinating Committee Meeting at the FDA’s White Oak Campus this week. The initial goal of CAMD is to define clinical data standards and establish a pooled database of the control group of pharmaceutical clinical trials in order to develop quantitative disease progression models for both Alzheimer’s and Parkinson’s disease.

Both Mark McClellan, ex-Commissioner of the FDA and Janet Woodcock, Director CDER, FDA spoke. Dr. Woodcock could not have been more complimentary of CDISC. She indicated that all therapeutic areas need data standards and that she is pleased that CAMD is working with CDISC to develop these standards. She said that groups should not go off and develop new standards, but should work with CDISC to add to the standards that have already been developed with vigorous review.

I have been working with the Alzheimer’s data group to finalize a data specification for a couple of questionnaires including ADAS-Cog, the primary cognitive measure for Alzheimer’s disease. These data specifications are currently out for review with the CDISC SDS team and the FDA.

If you would like to contact me to be part of future terminology developments, please contact me at ctolk@cdisc.org