PACE trial data

Esther12 said:
The people dishing out research grants aren't exactly keen to have greater scrutiny on PACE.
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I think we need to remember that the head of governance for the MRC went out of her way to back PACE. She dismissed complaints about outcome switching and she appeared in the information tribunal to stop data being released. The MRC and in particular their head of governance have been seen to be lacking. I don't think they will be keen to take up this issue either.

Perhaps when the MRC is gone and the research councils are merged we may get an organisation willing to actually check on issues with the research they are paying for.
 
Binkie4 said:
  1. " It said that SPSS and Stata software is required "(point 12)
  2. Is QMUL saying that they don't have this software in the University?
Absolutely agree with @Liv aka Mrs Sowester.
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They have SPSS licenses at least. With the fine data I extracted it from a Stata format using python (and I am not a python programmer) the instructions of how to do this are on stack exchange.
 
It does make you wonder if this could become a get out trend as soon as an organisation or the government for example gets a request for information they don't want released, they just have to retire or fire the person who would be said to be the information holder.

It sets a bad precedent.
 
Update.
This actually made me laugh: I have heard back from KCL and... They don't hold the data either apparently.
I shall be asking them to review the decision.
I have now prepared my appeal on the QMUL decision and shall be mailing it at the start of next week.
 
JohnTheJack said:
Update.
This actually made me laugh: I have heard back from KCL and... They don't hold the data either apparently.
I shall be asking them to review the decision.
I have now prepared my appeal on the QMUL decision and shall be mailing it at the start of next week.
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How can they claim that? McCrone is still there, isn't he?

We're still waiting for the LTFU data on employment outcomes!
 
The LTFU results are the only outcomes of real consequence in clinical trials, especially for chronic illnesses.

The LTFU for primary outcomes is null, however desperately PACE tried to spin it.

If the LTFU for employment is also null (which I expect it to be), then the psycho-behavioural model of ME being tested by PACE is indisputably a complete bust, those responsible for prematurely imposing it upon sick vulnerable humans are in utter disgrace, and its only remaining value is as a stark warning to future generations. :grumpy:
 
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Found this FOI from 2012:

requests info on recovery rates.
part of reply:
"
The information you have requested is not held. The requested data
relating to the recovery rates and positive outcomes do not exist. That is
to say that such analyses have not been done and there is no intention to
do so. The reason for this is that the analysis strategy has changed from
the original protocol as described below."
"
With regards to the recovery rates: the criteria thresholds for measuring
recovery in the Trial were changed in the light of more detailed
consideration of previous published studies (making the Trial’s analyses
either consistent with these studies or more stringent) and in the light
of newly published work (on the normal range of fatigue in the U.K.
population)."

www.whatdotheyknow.com/request/pace_trial_recovery_rates_and_po
 
Just catching up on this thread.

Binkie4 said:
"QMUL has explained that the Chief Investigator of the PACE trial retired from QMUL on 31 December 2016. While QMUL remains the holder and owner of the raw data from this clinical trial, it has effectively lost the means to locate and extract it because this requires specialist knowledge. There is no longer anyone at QMUL with the ability to produce data from this trial. QMUL no longer employs anyone involved with the PACE trial."
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Absurd. As if anyone would believe that an organisation the size of QMUL doesn't employ Access database administrators.

Adrian said:
I think this is a serious admission by QMUL it suggests they do not have an adaquate data management policy to support clinical trials. The spent 5m on this trial and they claim the data is so badly stored and documented that it can no longer be used. That should be considered unacceptable. The MRC should be seriously concerned.
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Inefficient use of taxpayers' money, taxpayer (or someone representing the taxpayer - is there such an organisation?) should be complaning.

Adrian said:
But it doesn't look good and I'm amazed that a modern organisation would attempt to use such an excuse.
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That's the usual lack of respect for anyone they deal with.

Inara said:
Edit: Just wanted to say that my impression was that documentation of programs is not a favorite, leading to the problem that new people don't understand it properly.
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Yes, I know that programmers are not usually particularly keen on documenting their work - but there should be policies and procedures in place and they should be adhered to.

Adrian said:
She dismissed complaints about outcome switching and she appeared in the information tribunal to stop data being released. The MRC and in particular their head of governance have been seen to be lacking.
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I find this unbelievable... not in a good way.
 
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Sly Saint said:
@JohnTheJack what happened with this?
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1. The hearing of the First Tier Tribunal for the QMUL request has been set for next Tuesday afternoon. On Friday, QMUL, with the support of the ICO, asked for a full-day hearing. The Tribunal refused this request, but the matter has now been referred to a judge. I await the decision.

2. The ICO has upheld KCL's claim it doesn't hold the data in terms of the FOIA. I got this decision a couple of weeks ago and sent off my appeal to the FTT yesterday. The ICO's decision is here https://ico.org.uk/media/action-weve-taken/decision-notices/2018/2260044/fs50735928.pdf
 
JohnTheJack said:
1. The hearing of the First Tier Tribunal for the QMUL request has been set for next Tuesday afternoon. On Friday, QMUL, with the support of the ICO, asked for a full-day hearing. The Tribunal refused this request, but the matter has now been referred to a judge. I await the decision.

2. The ICO has upheld KCL's claim it doesn't hold the data in terms of the FOIA. I got this decision a couple of weeks ago and sent off my appeal to the FTT yesterday. The ICO's decision is here https://ico.org.uk/media/action-weve-taken/decision-notices/2018/2260044/fs50735928.pdf
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@JohnTheJack would there be any benefit at all in setting up crowdfunding to pay an independent person, or putting out a call for someone to work voluntarily to extract the data so QMUL could no longer use that they don’t have anyone available as an excuse?
 
NelliePledge said:
@JohnTheJack would there be any benefit at all in setting up crowdfunding to pay an independent person, or putting out a call for someone to work voluntarily to extract the data so QMUL could no longer use that they don’t have anyone available as an excuse?
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I did try a similar line with the ICO who was sympathetic but rejected that approach: an FOIA request is for public release of data and so must be to the world at large and not to, for example, a researcher who would then make the information available.

The appeal with QMUL has been going reasonably and I think there is a chance, no more, that the Tribunal will order release.
 
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