PACE trial data

[Adrian]

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

I took that to mean they have the raw data but the knowledge to interpret it has gone. That is a suggestion that they have not documented their database, the schemas, what the different data fields are.

Either case suggest that QMUL are a highly unprofessional organisation (but that doesn't surprise me for an academic institution).

 

[Peter T]

PDW has retired

It may suit QMUL to say that White is unavailable to access the PACE data because he is officially retired from his main job, but he is not so retired that he can not give lectures to various groups including the Insurance industry or that he can not head up the PACE ten year follow up under QMUL.

QMUL were well aware that there is ongoing interest in this data and presumably the retirement of White did not come as a complete surprise to them. Given they are willing to spend tens of thousands of pounds in relation to fighting the sharing of this data, would it not be impossible for them to pay White for a few extra hours work while he is already working for them part time in relation to this data so he can direct someone else as to how to access it. You would have thought he would actively want to do this given the commitments as lead researcher he made to the participants in the original study, many of whom he is still in contact with through the ongoing follow up studies.

 

[Sean]

QMUL & White have no excuses for not providing data.

None.

 

[Adrian]

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.

That doesn't surprise me. But their continued covering for PACE doesn't paint them in a good light. The way I see it is QMUL were the responsible institution and need to demonstrate that they are capable of an appropriate level of governance.

 

[Sly Saint]

Spend 5 million on a study then someone leaves so therefore the data cannot be accessed any more. And this at a time when it is under scrutiny. I would say it's another thing for Carol Monaghan's notes to bring up with the MPs!

emailed her about this yesterday

 

[Invisible Woman]

He referred to Bart's being involve in an ME trial that was a 'complete disaster'.

They also need to understand that the "disaster" is not just about the lack of scientific rigour and all the other documented shenanigans, but how they themselves have dealt with the situation.

The university seem to be more concerned that they appear to have high standards, rather than actually having high standards. Instead of dealing with the situation head on and taking appropriate action they've simply tried to cover it up, in the knowledge that people were potentially being stigmatized and harmed, both physically and financially.

This we can't find it, don't understand it, the dog ate it makes them look completely incompetent. This is no !onger Peter White et al damaging their reputation, now they're doing it to themselves.

 

[Luther Blissett]

I took that to mean they have the raw data but the knowledge to interpret it has gone. That is a suggestion that they have not documented their database, the schemas, what the different data fields are.

Either case suggest that QMUL are a highly unprofessional organisation (but that doesn't surprise me for an academic institution).

I see I was being too generous.

This is worse than the usual "The crucial documents were kept in the basement. The basement flooded and destroyed all relevant records..." that is usually trotted out in cover ups.

This is saying the "records exist but we let the author write them in a secret code that nobody understands." What would have happened if Peter White became ill during the study and could not carry on? He was the only one who knew how the database worked?

Even if the database is hard to understand, we already have some of the results, so wouldn't it just be a case of replicating the published work and then deducing some or all of the fields? In other words, the answers are known, so enter some likely fields as variables, run through the data and see if it matches?

 

[Invisible Woman]

I think we are trying to explain the inexplicable here.....

How can any university be this incompetent?

 

[Adrian]

I see I was being too generous.

That was just my interpretation. But it doesn't look good and I'm amazed that a modern organisation would attempt to use such an excuse.

In truth I don't think the data is hard to understand and I suspect a decent data scientist could unravel it in a relatively short time. Especially in terms of the requested data. The details of what each test represents and the domain knowledge here may be missing but that is not being asked for.

 

[Daisymay]

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.

That's very interesting, thanks.

QMUL's primary responsibility should be the care and to protection of patients.

They know there is a serious problem yet they don't intervene to protect patients, their only concern seems to be to protect their institution ( and all the other institutions and government bodies concerned) and screw the patients.

Utterly, utterly shameful!

Jonathan, do institutions not have some sort of legal obligation for the safety and protection of patients affected by research carried out by their employees? Surely? Or am I being unbelievable naive.....

 

[Inara]

Would anyone be willing to provide some background information on what is going on? Sounds interesting, but I don't understand it entirely.

 

[Sly Saint]

Their statement from 2016:
"
The PACE trial was carried out according to the regulatory framework for UK clinical trials, which aims to ensure that trial participants can be confident that their information is only ever used according to their consent, and that their data is only shared under obligations of strict confidentiality. The outcomes were subject to the usual standards of peer review for published scientific research.

QMUL’s appeal against the Information Commissioner argued in favour of controlled and confidential access to patient data from the PACE trial in accordance with established policy and practice in medical research. QMUL had previously shared data from the PACE trial with other researchers only when there was a confidentiality agreement in place and an agreed pre-specified statistical plan for data analysis."

So what would they do if other researchers now wanted access?
Would they tell them 'sorry but we don't know how to locate it'?

Anyone like to ask?

Joel Winston
Public Relations Manager
Queen Mary University of London
email: j.winston@qmul.ac.uk

eta: ironically
£54 million award to transform health through data science
http://www.qmul.ac.uk/media/news/20...to-transform-health-through-data-science.html

 

[chrisb]

Joel Winston
Public Relations Manager

Lord Winston apparently has a son called Joel.

EDIT It is probably unlikely that this is he, but given the speech made in the House of Lords on an earlier occasion by Lord Winston it would be unfortunate if this were a relative of his.

 

[Inara]

That is a suggestion that they have not documented their database, the schemas, what the different data fields are.

My husband works in the academic data archiving area. Bad documentation is a huge problem. This also was an issue when I was doing my PhD. I tried to document and comment everything, but that was not common. Not sure, though, if an outstander would have understood it. To be fair I was not a high-profile programmer.

 

[Invisible Woman]

My husband works in the academic data archiving area. Bad documentation is a huge problem. This also was an issue when I was doing my PhD. I tried to document and comment everything, but that was not common. Not sure, though, if an outstander would have understood it. To be fair I was not a high-profile programmer.

I understand what you are saying here, but I'll bet your data wasn't based on a £5 million research trial which was going to guide the course of treatment for 250,000 patients in the UK and millions of patients worldwide.

QMUL’s appeal against the Information Commissioner argued in favour of controlled and confidential access to patient data from the PACE trial in accordance with established policy and practice in medical research.

Bolding mine: while they are arguing that access be controlled, they are stating that access will be possible (albeit controlled).

 

[Sly Saint]

from the pdf
"
The Commissioner queried why, since analysis
has been done by statisticians and not the Principal Investigators, the
retirement of one of the Principal Investigators would have an effect on
QMUL's ability to produce the information. She asked whether any of the
statisticians were ever employed by QMUL and if they were when they
ceased to be employed? She also asked if the analysis was only done by
statisticians why the Chief Investigator would have been able to do this
work."
"
QMUL explained that although the Principal Investigator did not
undertake the detailed analysis of the PACE trial’s data, he was the only
individual from QMUL with knowledge of the terminology and raw
database to actually locate the information."

what does this mean? Don't they have email or telephones at QMUL?

 

[Luther Blissett]

That was just my interpretation. But it doesn't look good and I'm amazed that a modern organisation would attempt to use such an excuse.

In truth I don't think the data is hard to understand and I suspect a decent data scientist could unravel it in a relatively short time. Especially in terms of the requested data. The details of what each test represents and the domain knowledge here may be missing but that is not being asked for.

If the University was acting in good faith, they would have popped down to the Computer Science department wouldn't they? Free advice, lots of specialists and students. That they and the ICO are pretending that the department doesn't exist is just the cherry on top.

The School of Electronic Engineering and Computer Science (EECS) is based at the Mile End campus and delivers world-class electronic engineering and computer science research and applies it to real-world problems, including bioengineering. Our current research grant portfolio of £38m equates to more than £500k for each research-active staff member. The School is home to over 70 academic staff, over 50 Post Doctorial Researchers and over 200 Research students. 8 School members hold prestigious research fellowships.

https://www.bioengineering.qmul.ac.uk/facilities/eecs/

I'm sure there is a possibility that people studying and teaching 'real-world problems' in computer science research might just have some ideas and solutions.

 

[Sly Saint]

again from pdf
"
In this case the request was made on 18 October 2016, prior to the
Chief Investigator's retirement, and therefore the requested information
could have been said to be held at the time of the request. The
Commissioner is however unable to order QMUL to take any steps as
she cannot find that the information is held now because QMUL no
longer has the means to obtain it."


"........In this case the complainant requested the internal review on 24
December 2017. The result of the internal review was not provided until
after 9 March 2017.
24. The Commissioner considers that a reasonable time for completing an
internal review is 20 working days from the date of the request for
review, and in no case should the total time taken exceed 40 working
days. In this case this time frame was exceeded."

shows that it is a load of BS.

 

[Inara]

I understand what you are saying here, but I'll bet your data wasn't based on a £5 million research trial which was going to guide the course of treatment for 250,000 patients in the UK and millions of patients worldwide.

No, mine not. But the archiving system my husband is building up is supposed to save more data, e.g. that about the Trojan findings.

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.

 

[Invisible Woman]

QMUL explained that although the Principal Investigator did not
undertake the detailed analysis of the PACE trial’s data, he was the only
individual from QMUL with knowledge of the terminology and raw
database to actually locate the information."

Again, this just shows up QMUL rather badly.

They take £5 million for a project and allow it go ahead without the correct procedures and policies in place to safeguard the data. As someone said earlier in the thread: what if something happened to Peter White after the data had been input and before it had been assessed? They would have told the DWP - sorry old pal, we can't give you any results to show for £5 million.

Also if the bolded bit was true, this means that he would have had to supervise the statisticians work each and every step of the way. Really? Even if this was true, then are we saying that the statisticians were too stupid to become familiar with the layout and terminology used? Over time, anyone using a system will becvome familiar with the terminolgy, acronyms and layout, regardless of their training.