Research Ethics Blog

New Alzheimer’s Database — Streamlined Research is Ethically Better

Here’s some good news for those interested (professionally or otherwise) in neurogenerative diseases.

From MedScape’s Deborah Brauser, New Database of Alzheimer’s Trials Available to Researchers, Clinicians.

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….

Three points are worth making.

First, this seems like a great initiative. Pretty much everyone recognizes the dangers (and inefficiencies) of the usual model, according to which research is conducted by separate teams at separate organizations, each hesitant to share its results — much less its data — with the others.

Second, the combined database holds the promise of reducing the pool of research participants needed for some kinds of research. One of the scientists involved in the database project says that, using this database, “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….” Yes, this method will reduce costs, but at least as important is the fact that it will also reduce risks to human research subjects.

Finally, interestingly, the story notes that “…all participating pharmaceutical members have agreed to a voluntary industry data standard on AD trials to help speed the FDA review process.” This seems like a good move. But the story doesn’t mention whether anything is being (or could be) done to streamline an approval process that happens earlier in the process, namely the Ethics Review process. Any academic researcher, at least, who wants to do research using this database is going to have to go through his or her university’s own Ethics Board first. And a multi-centre study might have to be approved by, well, as many ethics boards as there are institutions involved. It’s worth asking, at least, what (if anything) a consortium like this could do, even in principle, to solve that problem.