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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