PACE trial TSC and TMG minutes released

Thanks, would it be normal to have an Analysis Strategy Group? And if so why wouldn't they not have been mentioned earlier in say in the protocol?

I wonder when they came into existence, at the beginning or when they realised they needed to work out how on earth they could come up with seemingly positive results?

 

Sorry if this is not the right place to put this but it was posted at the other place and thought it was relevant.
SW always insists he had 'nothing to do with the PACE trial'

 

Keith noted this from meeting 16: https://twitter.com/user/status/977494101959565314

My question would be: Is there a safe way to do the step test in people with ME/CFS, given that it exercises to exhaustion? It's probably a reasonable objective measure because it doesn't allow the subject to pace themselves.

I'm presuming the step test they used is similar to this: https://en.wikipedia.org/wiki/Harvard_step_test

 

No, I agree with Trish that it is very odd for there to be an Analysis Strategy Group in existence after the trial has formally commenced. By 2000 it was very clear to people running trials that your analysis needed to be decided before you started. It rather looks as if the MRC fell well below basic standards on this in its 'CTU'.

More and more the message from this trial is not so much that the authors were incompetent but that the MRC was incompetent in its role as a guiding influence.

 

In the radio recording that someone uploaded here a while back Horton says the trial was eagerly awaited. It was clear from his tone that he knew well in advance that he was expecting a slam dunk trial.

I think this has to confirm the suspicion one has always had that the editorial policy at the Lancet was little more than mingling with the in-crowd and picking up what was a hot favourite. Again, in this regard the Lancet falls way below peer review standards in regular specialist journals like Arthritis and Rheumatism or indeed New England Journal of Medicine. One always suspected that but one did not often have the chance to see it in action.

 

So from TMG meeting 4, 23rd January 2004:

"7. Trial Steering Committee (TSC): Final Membership and Date of 1st Meeting

The MRC have confirmed approval of the membership. REDACTED, who is the director of the Clinical Trials Unit at the MRC, has agreed to chair the TSC. REDACTED has vast experience of clinical trials.... "

Does that therefore mean that REDACTED here is Wessely?

Does he really have "vast experience of clinical trials" ??

 

Not just Horton. The DWP provided some of the funding on the expectation that the trial would show CBT and GET to be successful. When asked why they funded PACE, they replied,

https://www.whatdotheyknow.com/request/part_funding_of_the_pace_trial_b

 

No. Janet Darbyshire was Director of the MRC CTU in 2004, I think. Wessely's CTU was at Kings.

 

There are sentences on the net looking very like the one @Daisymay quoted where the name is Wessely. He was certainly director of the CTU responsible for PACE as far as I can see, at least at some point. What is not clear to me is whether this is the entire MRC CTU or whether it is a subsection.

 

Yes, I think the role of DWP is fairly well documented. The question is where Horton comes in if he is supposed to be an independent editor publishing purely on scientific merit. Why was he eagerly awaiting such a scientifically boring trial?

 

*cough* I think it says more about the expectation that the more prestigious the institution and affiliations (and numbers of gongs on the byline), the more robust the research will be. I think The Lancet takes it way too much on trust that things will be done properly under those circumstances.

"It was a very easy trial to publish" because they felt they didn't need to do any checks. In my view, the more profs on the byline, the more scrutiny they should employ, since all the annoying pedantic juniors like me won't have been involved! It's airline safety protocols all over again.

 

That is the more charitable reading. I don't actually think it has to do with institutional prestige and affiliations. How did Andrew Wakefield get to be published? The Royal Free surgery department was hardly high profile. Horton did not come sniffing around when I was about to publish in NEJM from perhaps the most prestigious clinical science faculty in the world at the time - I guess because I did not go around touting my wares to chummy editors.

 

You typically eagerly await something when you are already primed up for it being likely to be what you want it to be. Primed how and by who?

 

Well, somebody here ought to know. People here seem to know everything! Or they soon enough find out.

I can think of some candidates.