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Request for information related to PACE

Discussion in 'General ME/CFS Discussion' started by JohntheJack, Apr 24, 2017.

  1. JohntheJack

    JohntheJack Senior Member

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    I have done a brief search for these, but wonder if someone could point me in the right direction to save me some time.

    I'm looking for:

    MRC Guidance for Applicants
    and
    MRC Good Research Practice: Principles and Guidelines

    In both cases in operation at the time of PACE (or equivalent). NB: I have the current ones.

    Also:

    Is the review by Gaskell of the request for TSC and TMG minutes available anywhere, does anyone know, please?

    Thanks in advnce for any help.
     
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  2. Stewart

    Stewart Senior Member

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  3. Esther12

    Esther12 Senior Member

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    Sorry, can't help you with the MRC documents. Have you tried contacting the MRC?

    There's the shitty tribunal judgement here: http://www.meassociation.org.uk/wp-content/uploads/PACE-Trial-tribunal-decision-22-August-213.pdf

    The ICO judgement is here, and includes some info on Gaskell, but I don't remember much being released on that: https://ico.org.uk/media/action-weve-taken/decision-notices/2013/797232/fs_50463661.pdf

    That Mitchell case gets my blood boiling. If there's anything you're working on privately about that, feel free to pm.
     
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  4. user9876

    user9876 Senior Member

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    I think they are very sensitive about the committee minutes because they didn't have permission for the outcome switching. My theory is that the presented the statistical analysis plan to the committee to approve changes in the outcomes but that SAP does not mention that changes are being made to the primary and secondary outcomes. Instead it just silently includes changes.

    I think we should be challenging them when they say the changes were approved because we have no evidence of any approval. They can release the minutes where approval is discussed.
     
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  5. Esther12

    Esther12 Senior Member

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    It could be worth making another request now that the prejudices Hughes used to justify his decision have been so widely discredited?

    Would need to be careful though, given clear precedent. We need a good UK journalist who knows what they're doing to start digging in to this stuff!
     
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  6. Snowdrop

    Snowdrop Rebel without a biscuit

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    Frances Ryan?
     
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  7. user9876

    user9876 Senior Member

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    I think given we now know the size and effect of the changes then the public interest case is strengthened. I believe one committee had blinded data available when they approved the SAP.
     
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  8. JohntheJack

    JohntheJack Senior Member

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  9. JohntheJack

    JohntheJack Senior Member

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    Thanks, Esther. See reply below.
     
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  10. JohntheJack

    JohntheJack Senior Member

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    I have put in another request. They have declined citing the earlier decision. I'm going to ask for a review and am in the process of drafting it.
     
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  11. JohntheJack

    JohntheJack Senior Member

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    If you have a source for that, I'd be grateful. Thanks.
     
  12. Esther12

    Esther12 Senior Member

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    Best of luck with that. It seems like they've been quite willing to use prejudices about ME patients in the past, and just having posted here, on the largest internet forum for patients, has been used to try to discredit those requesting info in the past.
     
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  13. Barry53

    Barry53 Senior Member

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    When it comes to ME ... is there one?
     
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  14. Esther12

    Esther12 Senior Member

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    @Snowdrop mentioned Frances Ryan. I've e-mailed a few journalists who have done work that looked relevent. I guess that we just need to keep trying, and hope someone takes notice. We only need one!
     
  15. user9876

    user9876 Senior Member

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    So the primary outcomes were changed in the Lancet paper and after Alem's FoI the outcomes as defined in the protocol were released and I think they were around a third of those published. They published the protocol defined outcomes as they should have done after the information tribunal ruled they had to release data:
    http://www.wolfson.qmul.ac.uk/images/pdfs/pace/PACE_bimodal_CFQ_analysis_final_8_Sept_2016.pdf
    http://www.wolfson.qmul.ac.uk/image...otocol_based_analysis_final_8th_Sept_2016.pdf


    Then the (Statistical analysis plan) SAP dropped recovery as a secondary outcome allowing them to publish a re-interpretation in their paper where they claimed a significant result when the original definition was a null result. We know this from both Alem's reanalysis on the virology blog and the Wiltshire paper.

    The statistical analysis plan can be found here and has a quote about blinded data
    https://www.ncbi.nlm.nih.gov/pubmed/24225069

    When I looked in the SAP I couldn't find mention of why changes were made but they could be buried there and I missed it.

    If they had looked at blinded data the lack of positive result would be blindingly obvious. The timeline is unclear they say that no analysis of outcomes has been produced but then follow this with a suggestion that descriptive stats were given to some committees. That is allowed but it does mean they need to be very explicit about the timelines.

    To me this strengthens the public interest case in looking at the minutes of the committees that approved the changes in order to understand how results were vastly exaggerated by the changes made. The public interest case is in ensuring that the trial committee system works properly and performs due diligence looking at all information.
     
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  16. user9876

    user9876 Senior Member

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    If you want someone to look it over and make suggestions you can PM me.
     
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  17. JohntheJack

    JohntheJack Senior Member

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    Yes, I have seen that about trying to show participation here is evidence of 'extreme militancy'. Thanks.
     
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  18. JohntheJack

    JohntheJack Senior Member

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    Thanks for all that. I need to take my time going through it.
     
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  19. JohntheJack

    JohntheJack Senior Member

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    Thanks. Still very much an incomplete draft at the moment.
     
  20. Stewart

    Stewart Senior Member

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    Don't know if this is helpful, but I've attached the earlier (Dec 2000) edition of Good Research Practice.

    I've had a quick look at the MRC website using archive.org and it doesn't look as though they introduced the Guidance for Applicants document until a couple of years after PACE was given the green light. Below is a link to the 'Advice for applicants' page on their website - as captured on 5th April 2004 - on the off chance that it contains the information you're looking for.

    http://web.archive.org/web/20040405...fic_schemes/funding-advice_for_applicants.htm
     

    Attached Files:

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