Abstract
Clinical trials have used many different data conventions which have limited the cross trial power. Global regulatory authorities and scientists cannot compare patient level outcomes including ADAS. Clinical Data Interchange Standards Consortium (CDISC) has become the standard for all regulatory submissions, but specific disease area standards have not been completed. The purpose of this project is to develop AD clinical content data standards for clinical trials data in collaboration between the CDISC and the Coalition Against Major Diseases (CAMD), a program of the Critical Path Institute. Scientists from the AD clinical community, industry, government agencies, academia, patient advocacy associations, and CDISC met regularly to determine AD standards which were put out for public comment in Dec 2010. An implementation guide comprises version 1.0 of the AD Therapeutic Area Supplement to the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG: AD v1.0 AD). Comments from the wider AD community have been included and now published, so health agencies, regulatory authorities and scientists have a better understanding from one clinical dataset to the other. The C-Path website had a large number of AD trials transposed to CDISC format.
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