Is the MHRA interim report on TGN 1412 a whitewash?


So the MHRA (the UK’s version of the FDA) has “issued an interim report”:http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2023515&ssTargetNodeId=389 on the TGN 1412 trial. Some people calling it a “whitewash.” In the meantime, ethicists are “raising serious questions”:http://www.bloomberg.com/apps/news?pid=10000100&sid=aG3sg1rIkL4U&refer=germany about how the informed consent was implemented, as well as compensation. The public testimony of the placebo patients certainly sounds rather damning, to say the least.

For now, I don’t think there will be that much that changes in the conduct of early phase trials, except perhaps a strengthening of informed consent and perhaps a one-at-a-time dosing rule. I imagine ethics committees, safety monitoring boards, or institutional review boards will have a stronger role.

I’m not sure where this increased scrutiny of clinical research organizations will lead. I don’t know what the rules are in the UK, but in the US they are tightly regulated, and the FDA audits them just the same as a pharmaceutical or biotech company.

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