TGN1412 – openess and transparency

By AnthonyLast updated: Wednesday, March 22, 2006 • Save & ShareLeave a Comment

Here’s another perspective on the TGN1412 tragedy in Michael Goodyear’s BMJ editorial [PDF]:

Finally, what does this trial tell us about the degree of transparency throughout the process of developing new drugs? Many groups have called for mandatory registration and disclosure of clinical trials and their protocols. Had this trial been available for public review, potential problems might have been identified and avoided. Despite claims of the need to protect competitive advantage, public interest overwhelmingly requires that all information about this drug and this trial should now be made publicly available immediately. Lives are at stake and there can be no possible reason, save liability, for secrecy. We have been assured repeatedly that proper procedures were followed, when the real question is whether they were the right procedures.

This tragedy creates one more imperative for an open culture in medical research, a culture that many fear is increasingly losing its way. There must be an immediate moratorium on CD28 research in humans until we have a better understanding of the potential for harm. Furthermore only an independent inquiry can restore public and professional confidence: the MHRA is compromised by its own role in regulating trials. Such an inquiry must have a broad remit, including the social, political, legal, and economic forces shaping new drug development. Its recommendations should consider mechanisms for an immediate centralised response to unexpected events—such as those at Northwick Park—from the global scientific community.

The issue of registration and disclosure of clinical trials was also covered in a post on Black Triangle called The morality of secret research in 2004.

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