New Database of Alzheimer's Trials Available to Researchers, Clinicians

Deborah Brauser

June 15, 2010

June 15, 2010 — A new standardized database, containing information on 11 clinical trials and more than 4000 patients with Alzheimer's disease (AD), has been released by the Coalition Against Major Diseases (CAMD) — a consortium of pharmaceutical companies, research foundations, and patient advocacy/voluntary health associations, with advisers from agencies such as the US Food and Drug Administration (FDA) and European Medicines Agency.

According to CAMD, the aims of the shared database will be to accelerate research on all neurodegenerative diseases and to help in the development of new medications. Trial information on Parkinson's, Huntington's, and other brain diseases will be added later.

"This will be the largest database of shared...neurodegenerative disease data openly available to qualified researchers in the world," say the participants in a release.

The included trials feature drug vs placebo designs rather than drug vs drug, and patient identifiers are removed to ensure privacy, reported Marc Cantillon, MD, director at the Critical Path Institute, a nonprofit organization that leads and manages the CAMD, in the Washington, DC, office.

"We want to help scientists identify characteristics of patients who are presymptomatic and most likely to benefit from new therapies," Dr. Cantillon told Medscape Psychiatry. "This should help in the design of better, more efficient treatment trials."

"In the past, each company generally came in with their own trials and stayed private," he added. "Now, by being able to share across the many sponsors who are trying to develop drugs in this arena, each can learn from the mistakes of the other in a precompetitive space before going on to their own separate development."

He noted that after applying to the committee and getting their credentials approved both academic and industry investigators will be able to access and analyze the combined data and even add in their own research.

In addition, all participating pharmaceutical members have agreed to a voluntary industry data standard on AD trials to help speed the FDA review process.

"In the past, this wasn't standardized so you could have a trial where something as simple as date of birth was collected in 5 different ways. With this database of 4000, and we expect it will be more, you're able to compare across the somewhat different trials but in a standardized way," explained Dr. Cantillon.

"By seeing what trend, slope, or curve the disease has, depending on the type of patient that it is in, then a scientist can build a 'what if?' scenario and then run it in a trial within the database instead of having to go out and recruit those patients, which is very costly," he said.

The coalition is also currently working on identifying biomarkers of early stages of AD and Parkinson's disease.

"This large, accessible database is for everyone's use, and having the data recorded in the same way in 1 spot will help all of these different groups in different ways. Even the FDA will be able to look at this and better answer questions about safety or standards for new studies in a way that they couldn't do before," said Dr. Cantillon.

"The [FDA] has supported and actively participated in this innovative and unprecedented public-private partnership from its inception. [We're] strongly committed to CAMD and other regulatory science collaborations that can speed safe and effective treatments to the public," said Joshua Sharfstein, MD, principal deputy commissioner of the FDA, in a release.

Critical Path Institute is funded by the FDA and by Science Foundation Arizona. CAMD members include Abbott, Alliance for Aging Research, Alzheimer's Association, Alzheimer's Foundation of America, AstraZeneca Pharmaceuticals, Bristol-Myers Squibb Company, CHDI Foundation, Eli Lilly and Company, F. Hoffman-La Roche, Forest Research Institute, Genentech, GlaxoSmithKline, Johnson & Johnson, National Health Council, Novartis Pharmaceuticals Corporation, Parkinson's Action Network, Parkinson's Disease Foundation, Pfizer, and sanofi-aventis US.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....