TRIALS AND TRIBULATIONS FOR NEW MEDICINES.
With a curious sense of timing, the European pharmaceutical industry came out this week with a commitment to greater transparency about clinical trial data.
The development of new medicines is, of course, a high-profile topic at the moment. Safety concerns over some widely-used products have led to high-profile withdrawals over recent weeks, and to renewed anxiety over the credibility of the assessment procedures and the validity of the data used to support applications for authorisation.
So in principle, it's just the right time for the drug industry to offer some reassurance about the value it attaches to transparency.
What is surprising about this week's declaration from the industry, however, is that it doesn't directly address the most prominent areas of current reflection. It limits itself to an engagement to greater public access to registries and databases of clinical trials.
This is a useful step in the right direction. It means that summaries of trial results and details of ongoing clinical trials will be publicly disclosed via free, publicly accessible databases.
But the hundreds of thousands of patients taking long-term treatments for chronic health problems may not find it goes far enough: many questions about the reliability of the drug assessment process remain unanswered by the...
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