Tuesday, October 16, 2012

Glaxo lifts the veil

As recently reported in Nature and other venues, GlaxoSmithKline will begin sharing raw data from its clinical trials.  This will include studies since 2007 on both approved and abandoned drugs. There will be gatekeepers in the form of an expert panel that will restrict access to those with legitimate scientific interests. While not perfect, this is a big step beyond previous practices in the industry.  However, Glaxo may be getting ahead of the curve because it realizes that by 2013 the European Medicines Agency will begin allowing access to clinical trials data for products it receives for registration.

Hats off to Glaxo (and to the EMA). The release of clinical trials data should be a major step forward in several ways. Not only will it help to ensure patient safety, but it may also be a start in constraining the cost of drug development by reducing redundancy in the clinical phase of pharmaceutical research.  The vast increase in the cost of new drug development over the last couple of decades can largely be traced back to failed phase II and III trials. When those trials are done behind a veil of corporate secrecy there is no learning from past mistakes and no benefit to the research community.

The Glaxo and EMA decisions point to a path that should have been taken years ago. 

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