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Tegenero TGN1412

7 October 2010

There was a piece on Radio 4’s ‘Thinking Allowed‘ yesterday in an interview with Professor Adam Hedgecoe about ‘normalisation’ of practice. He describes how it had become normal to dose subjects in clinical trials of new medicines at fairly short intervals.

After the extremely serious adverse events experienced by the volunteers that participated in the trial there was a lot of hoopla by ‘experts’ stating that short dosing intervals were wrong and inappropriate. The fact is, that everybody did it this way. It goes without saying that the more cautious approach that we take today is better.

It was good to hear an interview that didn’t seek to sensationalise the story.

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6 Comments
  1. Peter Lassoff permalink

    Hi! Hope you’re OK. I heard this as well. As usual, I thought that hindsight is always perfect. I heard NOTHING about not dosing as everyone did it before the study. Sure, afterwards it seems like a good idea to change it, but the idiots who pontificate about how dosing should have been staggered should have said something beforehand. Oh well, such is life…

  2. I’m with you on that Peter! Thanks for posting.

    All the best.

  3. Adam Hedgecoe permalink

    I’m glad you liked the interview. More importantly, given that you seem to have a background in CROs/clinical research, am I right in thinking that my point (that short interval dosing was ‘the norm’ pre-northwick park) is correct? (always good to get additional views on ones’ analysis).
    regards

    adam hedgecoe

    • Hi Adam, thanks for your reply. I should put my cards on the table and say that I used to work for PAREXEL at their Unit in Harrow. But I’ve also worked for other high calibre Phase I Units in the UK (and one in the US – also PAREXEL). I should also point out that I am not medically trained. Having said that, I am happy to restate that it was typical in the industry to dose an entire cohort of subjects with an oral formulation at fairly short intervals (from 2 minutes for bioequivalence studies with marketed drugs, to 3-5 minutes for new chemical entities. Longer intervals might have been seen for very complex trials with lots of procedures that were very staff intensive. You would also probably have seen longer intervals between dosing for IV administration, as monitoring was usually more intensive. But I don’t recall that before TGN1412, we would have dosed 1-2 subjects and then waited for a day before dosing the remainder of a cohort as would be done today. Rather than rely on my view, you’d be better off talking to investigators that have worked in this field if you haven’t already done so.

      Regards

      Steffan, Cardiff alumnus 1987

Trackbacks & Pingbacks

  1. 2010 in review « Goofing Off
  2. Sir Michael Rawlins on Tegenero TGN1412 « Goofing Off

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