PACE trial data

Posts have been moved from this thread:
Guardian: George Monbiot 'Apparently just by talking about it, I’m super-spreading long Covid', April 2021 - Discusses ME/CFS and PACE

https://www.s4me.info/threads/more-pace-trial-data-released.9401/page-6#post-167893

 

Yes, I will do this.

 

I found the full statement (archived) here https://webarchive.nationalarchives....org/news/browse/criticism-of-the-pace-trial/. It mentions they are "supporting" the PACE triallists to anonymise it and make the data available on the CSDR web portal. It's not rocket science is it? Yet 2.5 years later, the data is still not there, despite all that support. Will write to Prof Watt asking why asap.

 

The more they strive to block release of the remaining PACE data, the more obvious it is they fear independent analysis of it. I thought I read somewhere that patient identifying data was confined to just one of their databases, and segregated from the rest of the data, to ensure anonymity, but I cannot find anything of that now, so maybe I am wrong. Either way, it's a pathetic apology for an excuse, and it is most definitely an excuse.

 

Delay tactics, smoke and mirrors, world wide press releases, those are just some pieces of a nasty puzzle. It doesn’t look like honest science.

 

[Added - I don’t know how the following relates to putting the PACE data on the CSDR web portal ... ... ]

My understanding is that Queen Mary’s is now refusing to release any further PACE data to FOI requests on the grounds that Prof Peter White’s early retirement means that the cost of bringing new suitably qualified people in to identify and process the relevant data would be prohibitive.

On a total unrelated note Prof White was, last time I looked, still listed as the lead researcher in the apparently ongoing ten year follow up to the PACE trials and continues to regularly give talks to the insurance industry. This rather begs the question of how the PACE follow up can do any stats if they can not access any of the original data?

Does QMUL have any ongoing legal obligation in relation to protecting the data that arose from the £5 million PACE? Also if an institution considered the data so valuable that they spent nearly £250,000 to try to prevent other people looking at it, shouldn’t they know what that data involves and where/how it is stored?

[Added - Also Prof White’s retirement was in late 2016 which seems to predate the commitment to put the PACE data on the CSDR portal. Does this mean QMUL are reevaluating their position that the data is for all practical purposes inaccessible, in which case have they informed the people whose FOI requests they rejected on those grounds?]

 

I will mention this in the letter I sent to the MRC

 

Being retired or leaving an institution doesn’t absolve you of your duties as principal investigator. Since publications are still coming out such as the long term follow up paper clearly one or more of the investigators is still managing the database. This is yet another lie they’re spinning to prevent release of the full dataset.

 

Prof White's continued activity on ME/CFS since his supposed retirement also begs the question of why he would not be able to help nowadays in releasing the data. As recently as May 2020 he registered a protocol for a systematic review on PROSPERO.

ETA: and the review is making progress -- the last update on PROSPERO is dated September 1, 2020.

ETA2: in the last year, Prof White was listed as an author on 4 publications and all are related to ME/CFS.

One of those is directly about the PACE trial, "Patterns of daytime physical activity in patients with chronic fatigue syndrome".

Two others are based on large cohorts that would have required a fair amount of handling data:

- Treatment outcome in adults with chronic fatigue syndrome: a prospective study in England based on the CFS/ME National Outcomes Database

- Prevalence of comorbid mental and physical illnesses and risks for self-harm and premature death among primary care patients diagnosed with fatigue syndromes

 

Sounds like a very active retirement!

 

I don't even understand how this ever was an argument when some PACE participants are already known, in addition to the obvious question of: and what would be the point?

This is just fear porn, implying some unnamed and unspecified threats out there, somewhere. It's the fact that anyone takes this seriously that is the concern, arguments so absurd they disqualify anyone pretending there ever was anything there. It frankly reminds me exactly of how Antifa is used as a bogeyman in the US, at this point they may as well be warning about the threat caused by mole people if they ever get their hands on the data.

 

An argument completely nullified by the steering committee minutes which clearly state they did prepare for this, as they were very likely obligated and expected to given the massive funding they received. It's the "my dog ate my homework" of excuses.

It's probably simply an issue of someone wanting to litigate it because as excuses go this one is especially pathetic and would never pass a tribunal's scrutiny.

 

This really doesn't wash at all. The idea that accessibility of data is reliant upon availability of individuals is absurd. Yes, if a key member of a team gets run over by a bus (as the saying goes) then it may be more difficult, but it should not be a total blocker.

In fact I think it should be a requirement of trials that their data should be readily accessible for at least 25 years (maybe a lot more) after the trial has been published, probably stated in the protocol. It should be a condition of a trial being sanctioned, and consequences if not adhered to.

I know that for FOI requests the cost of acquiring that data is taken into account but the cost that should be used is not necessarily the actual cost, but the cost that it should be, otherwise it opens the floodgates to all manner of pathetic excuses.

So in this case it should be argued that the only reason the cost of accessing the data is as high as they say, is because things were not done properly in the first place. The costs they claim it to be now are not a valid objection - it is not acceptable to claim it too costly when it is their own incompetence which makes it so.

 

The PACE trial data is apparently now available.

see https://www.s4me.info/threads/nice-...-adults-includes-cfs.20002/page-4#post-359239

study search link
https://search.vivli.org/?search=pace trial
https://search.vivli.org/studyDetails/ed05799f-dd14-4f0e-87aa-dd3e7b7951bd

in case the above links don't work

I eventually found it was sufficient to search on PACE trial (various others things eg chronic fatigue syndrome, got nowhere!)

eta:
https://vivli.org/vivliwp/wp-content/uploads/2020/12/Request-Studies-on-Vivli.pdf

 

An attempt by an independent observer to get the data:

https://twitter.com/user/status/1422620530893631492

 

Vivli:

https://vivli.org/about/board-directors/

https://vivli.org/about/founding-organization/

"Quote:"
Vivli evolved and was launched from this project of the MRCT Center to enhance access to clinical trials data by promoting data sharing and transparency.

A thank-you to the PACE team for highlighting yet another avenue for Orwellian dystopia in Medicine when it comes to anything touching on ME.

 

A question probably hard to answer but: is this the normal gatekeeping, or is there a special gatekeeping for this one? Because this is obviously not transparency and appears deliberately dense. If this applies to all data then the platform is just trash and defeats the whole purpose.

Edit: I pretty much answered my question, this appears to be the normal process, this is really just a data gatekeeping platform, not at all about transparency: https://vivli.org/vivliwp/wp-content/uploads/2020/12/Request-Studies-on-Vivli.pdf.

 

Trying to see if it's possible to confirm that the data have really been available for 2 years, either scenario is straight up malicious regardless, but it's notable that the data page on PACE is largely incomplete. So no date records, appears impossible to check and of course not archived on Wayback machine. MRC number appears correct. Hadn't noted that it's categorized under "Mental and Behavioural Disorders", which really emphasizes how incredibly disingenuous these people are, pretending they don't mean that.

There appear to be 2 pages even: https://search.vivli.org/doiLanding/studies/00006557/isLanding and https://search.vivli.org/studyDetails/ed05799f-dd14-4f0e-87aa-dd3e7b7951bd. Both are incomplete, one basically has no data.

Another source for trial data says available from 2019: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20098, although it's missing a lot of data. It appears they may have fragmented the data to make it harder to find? Kind of like they did by separating it all in several papers to coat the results in confusion.

Either Vivli is a joke of a platform or whoever handles it has phoned it in. Anyway this is both clownish and amateur.

 

Just tried again and even PACE trial now seems problematic;
luckily the other link I posted does work.
So the easiest way to access the request data page is to go through the Quick study lookup and use the Protocol ID : MRC-G0200434

https://search.vivli.org/