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I think someone had done some analysis and the drug companies had cleaned up their act quite well but universities were less likely to follow good methodology. The last thing drug companies want is for a drug not to be approved because they have not followed the rules. They probably think more...

I've been wondering about this. Data scientists often talk about the need to have subject matter experts who understand the data in order to get good analysis results. In this case I think that would mean having someone who understands the nature of the measurement instruments and hence how they...

Its not just the trial as handled by the MRC but also how they handled issues afterwards. They dismissed complaints including the changing of endpoints saying it would have little effect. They also acted as a witness in the information tribunal to try to suppress access to the data (perhaps...

Also from that FoI One of the reasons I think it is important is to understand the reasons given for changes that were made. The ones published in the Lancet aren't sufficient to justify the change in my view so this leads me wondering is there more (reasons) or could they get away with anything.

Did we know that? My feeling for a while is that they slipped in the changes to the analysis plan rather than being explicit about them. These minutes seem to me to confirm that but I think it is up to them to provide evidence of approval. I think the other important question is around the...

I thought this was interesting in the TMG minutes from the 4th of november 2009 But the minutes from the previous TSG meeting are dated 29th April 2009 with the following meeting being 10th Sept 2010 In the previous minutes of the TMG on the 23rd of June 2009 they seem to report on the 29th...

It may just reflect the coming of the internet and the ease of getting new information. This goes back to the 70s in terms of papers published http://europepmc.org/search?query=AUTH:"Aylward+M"&page=2 but there can be some naming confusion [Added] One letter...

I thought the PACE day where they get all the therapists together was interesting. Is this where they get to hear what is going on in all the trial centers? It was intended to be a moral booster but its also ensures information exchange about progress (in an open label trial).

The stats plan dropped recovery as a secondary outcome. I think their claim is that the stats analysis plan replaces the protocol. There is nothing earlier in the minutes suggesting any awareness of the protocol changes. Quite a lot of detailed discussion around the table formats but nothing...

Most research seems to involves a lot of hype so that may be hard.

I would read it as a statement that the analysis plan wasn't expected to override and change the protocol which appears to be what happened. As far as I can tell the TSC never approved the final protocol changes just an analysis plan that failed to point them out, When the results were...

Interesting tweet from David Marks. I think he makes an important point about passive approval of the stats plan.

In one of the early sets of minutes it seems clear that they will publish in the Lancet because they are asking whether the way they registered to trial is ok for the lancet.

I'm still reading the TSG minutes but its not just the analysis plan they hadn't done for the start of the trial. The database wasn't ready and part way through the first year they were just moving to version 6. What has really struck me about the minutes is they clearly lack any form of...

George Monboit who is an environmentalist and guardian columnist has written a bit on the SMC http://www.monbiot.com/2003/12/09/invasion-of-the-entryists/ http://www.monbiot.com/2011/06/13/naming-the-genocide-deniers/

When they were looking to raise the SF36 score acceptable for recruitment the PACE PI's understood just how subjective the questionnaires were. (Just not when used for results)

I agree, I think things should move to the analysis being pre-coded so that as the last data is added to the database then the results tables would be produced. The PACE people seemed to have trouble 'cleaning data' so applying certain checks on the data can be helpful to detect possible errors.

An interesting comment on data sharing given their refusal to release data and the MRC backing up this decision in the information tribunal.

My interpretation is they dropped it as a secondary outcome in the analysis plan and then later produced an adhoc recovery definition created after the initial paper was published. They seem more concerned about PR strategies than the analysis plan and I've yet to come across protocol changes...

Did they select the people who wrote the editorial in the Lancet that made recovery claims based on their 'normal range'