A user guide outlining standardised data elements to help pharmaceutical companies and medical researchers collect, pool and compare data from clinical trials for Alzheimer’s disease (AD) has been released by the US-based Critical Path Institute (C-Path) and the Clinical Data Interchange Standards Consortium (CDISC).

The two non-profit organisations, both affiliated with the Food and Drug Administration and set up to address process gaps in medical research and drug development, announced a formal partnership last January to set new clinical data standards aimed at facilitating development of new therapies for major diseases.

C-Path and CDISC had already been working together on an Alzheimer’s disease clinical database, launched by C-Path’s Coalition Against Major Diseases (CAMD) in June 2010. It used CDISC data standards to combine patient data from eleven clinical trials that were openly shared by seven pharmaceutical companies.

Among these CAMD members were Abbott, AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Pfizer and sanofi-aventis. C-Path also teamed up with Ephibian, a Tucson, Arizona-based company specialising in software development, databases, web solutions and information security, to build a secure online data repository for the Alzheimer’s initiative.

User guide

The latest product of these efforts is version 1.0 of the Alzheimer’s disease (AD) Therapeutic Area Standard (SDTM AD/Mild Cognitive Impairment User Guide).

The guide reflects consensus between CAMD collaborators, which include global stakeholders from C-Path, CDISC, the AD clinical community, the pharmaceutical industry, government agencies, academia and patient advocacy associations, on relevant pooled data domains, terminology and definitions for Alzheimer’s disease studies.

According to Lynn Hudson, C-Path’s chief scientific officer and executive director of CAMD, the initiative will ultimately generate “increased efficiencies so that the U.S. Food and Drug Administration and other regulatory agencies can more quickly and accurately review new applications for AD therapies, making it possible for medicines to reach patients more quickly and with greater assurances of safety and effectiveness”.