Alzheimer's clinical trial data made public
Shared resource will help accelerate neuro-degenerative disease research
The US Coalition Against Major Diseases (CAMD) has released a database of more than 4,000 Alzheimer's patients who have participated in 11 industry sponsored clinical trials. It is claimed to be the first database of combined clinical trials to be shared openly by pharmaceutical companies and made available to researchers worldwide.
The detail and scope of this database will enable researchers to predict more accurately the course of Alzheimer's, Parkinson's, Huntington's, and other neuro-degenerative diseases, thereby enabling the design of more efficient clinical trials, says CAMD.
CAMD is a consortium of pharmaceutical companies, research foundations and patient health associations, with advisers from government research and regulatory agencies. CAMD is led and managed by the Critical Path Institute (C-Path), which is funded by an agreement with the US FDA and a matching grant from Science Foundation Arizona.
In addition to sharing data, the pharmaceutical members of CAMD have agreed to use the common data standard established for Alzheimer's disease by CDISC, a standard-setting organisation, in their future submissions for drug approvals.
‘Scientists around the world will be able to analyse this new combined data from pharmaceutical companies, add their own data, and consequently better understand the course of these diseases,’ said Raymond Woosley, chief executive of Critical Path Institute (C-Path).
‘Data sharing is the backbone of several CAMD projects designed to identify patients who might develop brain diseases, i.e. before symptoms are apparent,’ said Marc Cantillon, director of CAMD. ‘Our goal is to develop tools to prevent or slow these diseases so patients can maintain independence and quality of life.’
The CAMD database will allow researchers to design more efficient clinical trials that have the maximum chance of demonstrating if a new treatment is safe and effective.
In addition, the coalition is identifying biomarkers that highlight patients in the very early stages of Alzheimer's and Parkinson's.