Drugmakers Share Data

Seeking to accelerate the search for Alzheimer’s disease cures, big pharma firms are drawing back the curtain on years’ worth of patient data from clinical trials. The Coalition Against Major Diseases, a consortium that links drug companies, research foundations, patient-advocacy groups, and advisers from U.S. and European regulatory agencies, has established a publicly available database with information on more than 4,000 Alzheimer’s disease patients from 11 clinical trials.

Companies contributing data include AstraZeneca, Abbott Laboratories, Johnson & Johnson, GlaxoSmithKline, Novartis, Pfizer, and Sanofi-Aventis. They are expected to eventually add data about patients with other brain diseases such as Huntington’s and Parkinson’s.

“Scientists from around the world will be able to analyze this new combined data from pharmaceutical companies, add their own data, and consequently better understand the course of these diseases,” says Raymond Woosley, CEO of Critical Path Institute, a nonprofit funded by FDA that will manage the database.

The drug companies also have agreed to apply a common data standard for Alz­heimer’s disease when filing for drug approvals. The hope is that sharing data will improve clinical trial design and speed the identification of biomarkers of neurological diseases, helping to ensure that treatments are truly effective.

The participants’ ultimate goal is to be able to identify people susceptible to neurological diseases before their symptoms emerge. After several failures of clinical trials involving patients with full-blown Alz­heimer’s, some neurologists have concluded that treatment can be effective only if started before the disease has advanced significantly.

The database is the latest in a string of collaborative efforts by pharmaceutical firms hoping to accelerate drug development. The scope and goals of the pacts vary. For example, Abbott, J&J, Eli Lilly & Co., Merck & Co., Novartis, and Pfizer are partners in Enlight Biosciences, a collaboration devoted to pulling transformative ideas out of academia.

Merck and AstraZeneca are conducting a trial to test a combination of two cancer drugs, AstraZeneca’s AZD6244 and Merck’s MK2206, that have yet to be approved. Recently, Lilly, Merck, and Pfizer said they would fund the Asian Cancer Research Group, a public pharmacogenomic database intended to speed development of treatments for cancer.