PACE trial data

To be fair, the ICO did ask them some questions this time, just not enough to really dig into the details of how the data is stored and what would be needed to release it.

 

I wonder if NICE have the teeth to extract the data.
PACE is pivotal, not only to ME, but many of the MUS stuff.

it was one of the final points raised at our table. PACE needed to be looked at again in light of reanalysis of data released following FOI tribunal.

 

@JohnTheJack are you able to share the grounds on which you can/will appeal?

And congratulations on your persistence so far!

 

@Trish-my conclusion too.

 

Almost no chance of that imo.

As time passes, the risk of some terrible accident of other increases though.

 

My memory is unreliable but isn't Peter White leading the ongoing follow up of the PACE study for QMUL? Presumably this means that QMUL are being deliberately disingenuous in their statement that White is retired. If he is available for this follow up, how is he not available to direct someone to access the original data? Also how can a meaningful follow up be undertaken if there is no access to the original data?

Is anyone one on sufficiently good terms with their MP to feed this scandal that QMUL have effectively allowed the loss of the data from a multimillion pound government funded study into the upcoming Westminster Hall debate? Given that QMUL have been fighting for years to prevent the sharing of this data they can not reasonably claim that they were unaware of potential problems accessing the data because of changes in their employment of the original researchers.

 

Ticky box

 

David Tuller had asked for the raw data December 2015 http://www.virology.ws/2015/12/17/a-request-for-data-from-the-pace-trial/

 

From Professor Malcolm Hooper's "Magical Medicine" p254 and p255

http://www.margaretwilliams.me/2010/magical-medicine_hooper_feb2010.pdf

The “Invitation to join the PACE trial” leaflet assured participants of confidentiality: “The data and recordings we collect will be securely stored for 20 years after the end of the trial, for your protection and to follow good clinical practice (GCP). The same applies to other records gathered for our study, including your medical notes and the database holding the collected data from the trial. Your name, address and telephone number will be on only one database. This will be held securely at St Bartholomew’s Hospital, in London, and it will be used only to monitor recruitment. You will not be named in any published study results from our study”.


When the PACE Trial had been running for two years, the Participants’ newsletter (Issue 1, June 2006) reaffirmed that the trial data was safe: “The information is being entered onto a large and secure database, designed and maintained by an independent clinical trial unit at King’s College, London”. This seems to conflict with the “Invitation to join the PACE Trial” leaflet (see above), which states that the data will be held securely at St Bartholomew’s Hospital. "

Edit: Margaret Williams just said this to me -

If the data is “securely stored”, then it is accessible.

If QMUL have no-one to analyse it, then tax-payers have the right to have it analysed by someone not employed by QMUL.

The data is tax-payer’s property.

 

I call shenanigans.

The data (either whole or in part) should be held on their systems (there should also be backup(s)). If their IT support can't find it or extract it, then they might try mentioning it to the Computer Science department. A nice bit of real world experience for students to grapple with.

'it has effectively lost the means to locate and extract it because this requires specialist knowledge.'

Looool.

looooool

erm, no. The raw database would be easy to find. Even if you don't know how to use or read the format it is in, it is easy to locate. I wonder if their IT department know that the University is calling them inept?

 

Just a thought. Is anyone in a position to get this information to that MP who has organized the PACE trial debate in the UK Parliament next week?

 

Here's one page related to that: https://www.hra.nhs.uk/planning-and...ies/pace-10-year-follow-up-feasibility-study/

I wonder what is going on with that, and the other PACE papers that have still not been released.

 

I would think that in the current climate, they would not really want to continue this study, or at least be very selective with their results..

From another angle, yes PDW has retired but AFAIK, is still alive and well. He appears to have the capacity to give lectures/advise insurance companies etc, so surely he'd be happy to assist his old Uni regarding this "landmark trial" if his knowledge is really needed.

 

Maybe Robin Callender Smith (QMUL) has an opinion, I think he and his wife signed the Raciannello letter to Arch Dis in Childhood re EC's SMILE trial.
If someone has contact details maybe he would consider relaying info to Carol Monaghan for the 20 Feb debate.

 

Yea, wasn't this one of the reasons given for not releasing it? Because they wanted to publish further studies? How can they do this now without revealing that they have access to the data?

I wonder whether this is a win in a way. That they've at least given up on churning out more PACE BS.

 

I had an interesting conversation with a senior academic associated with Bart's/QMUL this week. He referred to Bart's being involve in an ME trial that was a 'complete disaster'. He and I were meeting in relation to some work involving critical evaluation of the quality of drug trials. I got the impression that PACE is now regarded as a huge academic embarrassment for QMUL. Despite the bravura I suspect that even White now realises that putting out more papers is just making him look more and more ridiculous.