C-path manages an industrial consortia of companies willing to share precompetitive knowledge and work in support of projects that are identified as high priority by the FDA and are in the interest of public health. Since 2005, over $20 million in grants and $10 million in contributions have been received to support its work. To serve as a neutral and trusted third party for collaborators, C-Path says that it does not accept money from organizations that develop products regulated by the FDA or that would create a real or perceived conflict of interest.
Created jointly by C-Path and the Engelberg Center at the Brookings Institution, CAMD’s members include six nonprofit groups representing patients’ interests, 15 pharmaceutical companies, FDA, EMA, the National Institute on Aging (NIA), the National Institute of Neurological Disorders and Stroke (NINDS), and representatives from academia.
Broadly stated, the CAMD’s initial work involves the sharing of clinical trial information by its corporate members to generate the core information needed to build new disease models that represent populations. These models incorporate data from concurrent research as well as biomarker information from other research efforts. CAMD has the active participation of the FDA and its commitment to review data for possible qualification. The coalition plans to seek qualification for these models and biomarkers and place them into the public record to enhance research and drug development.
In 2010, seven of CAMD’s member organizations agreed to share their data from 11 recent AD clinical research studies. Data was standardized, pooled, and made available to qualified researchers around the world. They invested significant in-kind resources to remap the retrospective data to the new format that is now part of the Clinical Data Interchange Standards Consortium (CDISC) standard.
Those organizations included Abbott Laboratories, Alzheimer’s Disease Cooperative Study, AstraZeneca Pharmaceuticals, GlaxoSmithKline, Johnson & Johnson, Pfizer, and Sanofi-Aventis. C-Path also worked with Ephibian to build a secure online data repository. Data from additional drug makers and the NIH will be added in the future, according to CAMD.
Increasingly, CAMD’s approach integrates a “disease model” and a “drug model,” which together are used to simulate and design clinical trials with a greater chance of success. During the process, participants remapped their data to the new CDISC standard and combined them into a 6,000-patient database now being actively used by CAMD to test initial scientific results before formal submission to the FDA. To generate new data for this number of patients would cost millions of dollars and take more than six years in new clinical trials, the institute says.
“One of the things we learned was that getting the data was just the first step,” Dr. Woosley noted. “For example, no drug could have ever been found effective in these studies because many of the patients never progressed. Looking at trial data, it was all over the place.
“Once you got 6,000 patients in a usable database, at the first cut last December, we were able to produce a quantitative disease model that would allow us to track progression in three different patient subsets: nonprogressors, slow progressors, and rapid progressors. So for future studies you can design a study with adequate power and duration and identify an effective drug.
“To me,” Dr. Woosley added, “it demonstrated that the industry was willing to put in the time to get the work done to understand the data well enough to merge it. Setting data standards was our biggest accomplishment.”