BMJ: One promise fulfilled, much still to be done [clinical trials transparency]

British Medical Journal
03 January 2015(vol 350, issue 7989)

Editor’s Choice
One promise fulfilled, much still to be done
Fiona Godlee, editor in chief, The BMJ
This year, 2015, was the deadline for some pretty big promises. When these were made it must have seemed a long way off. In an article in the Lancet in 2004 I and others set 2015 as the date when there would be, we hoped, “health information for all” (Lancet 2004;364:295-300). More prominently, 2015 was the deadline for the United Nations’ millennium development goals. Now, with much achieved but of course still more to do, we are into the post-2015 development agenda.
But one important promise for 2015 has been fulfilled. The European Medicines Agency said that it would make publicly available the raw data from clinical trials of all newly approved drugs. And despite legal action from the drug industry (doi:10.1136/bmj.f1636) the agency has pushed ahead, and the new policy is in place. It will be a little while longer—until mid-2016—before it takes full effect. And the agency can still make restrictions and redactions to protect commercial confidentiality.
However, the fact remains that within two years the public and researchers will be able to read, in full, clinical study reports for all newly approved drugs, whether the trials were conducted by the industry or academia. This is an enormous achievement and something to celebrate…