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”: on the TGN 1412 trial. Some people calling it a “whitewash.” In the meantime, ethicists are “raising serious questions”: 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.

%d bloggers like this: