Pharma Companies Form a Clinical Information-Sharing Consortium - Pharmaceutical Technology

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Pharma Companies Form a Clinical Information-Sharing Consortium


ePT--the Electronic Newsletter of Pharmaceutical Technology

The Critical Path Institute (C-Path) announced last week the formation of the Coalition Against Major Diseases (CAMD), a formal consortium of pharmaceutical companies, research foundations, patient-advocacy groups, health organizations, and regulatory agencies, which will share information on clinical trials for treatments for neurodegenerative diseases. C-Path is a nonprofit organization focused on facilitating collaborative efforts among scientists from government, academia, patient-advocacy groups, and the private sector to support the US Food and Drug Administration’s Critical Path Initiative, a regulatory science initiative designed to improve medical innovation.

CAMD released a new open database of clinical-trial information from participating pharmaceutical companies to enable information-sharing among companies and researchers on a global basis. The database includes information from 11 industry-sponsored clinical trials involving 4000 Alzheimer’s disease patients. The database is designed to share information to enable the design of more efficient clinical trials for Alzheimer’s disease and in the future will include such information relating to Parkinson’s disease, Huntington’s disease, and other neurodegenerative diseases.

In addition to sharing data, the pharmaceutical members of CAMD have agreed to use the new common data standard established for Alzheimer’s disease by the Clinical Data Interchange Consortium (CDIC). CDIC is a standard-setting organization that establishes standards relating to the acquisition, exchange, submission, and archive of clinical-research data and metadata.

CAMD is led and managed by C-Path, which is funded by a cooperative agreement with FDA and a matching grant from the Science Foundation Arizona, a public–private nonprofit organization focused on facilitating science-based initiatives. Pharmaceutical companies participating in CAMD are Abbott (Abbott Park, IL), AstraZeneca (London), Bristol-Myers Squibb (New York), Eli Lilly (Indianapolis, IN), Forest Laboratories (New York), Roche/Genentech (Basel), GlaxoSmithKline (London), Johnson & Johnson (New Brunswick, NJ), Novartis (Basel), Pfizer (New York), and sanofi-aventis (Paris). CAMD also includes advisors from government and government research agencies, including FDA, the European Medicines Agency, the National Institute of Neurological Disorders and Strokes, and the National Institute on Aging.

“The US Food and Drug Administration has supported and actively participated in this innovative and unprecedented public-private partnership from its inception,” said Joshua Sharfstein, FDA’s principal deputy commissioner, in a C-Path press release. “The agency is strongly committed to CAMD and other regulatory science collaborations that can speed safe and effective treatments to the public.”

In addition to CAMD, C-Path also manages the Predictive Safety Testing Consortium, a pharmaceutical-industry collaboration that shares internally developed laboratory methods among the major pharmaceutical companies and researchers to predict the safety of new treatments before they are tested in humans.

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