FOI request re PACE Cost-Effectiveness Analysis

Sly Saint said:
Don't know if this has been posted already or not.
This is from the MRC in Aug 2018:

"The MRC has recently started (with other research funders) a pilot of a new facility for academic researchers to share data via the Clinical Study Data Request (CSDR) web portal. We hope to include the PACE trial on the CSDR portal within the next 6-12 months. This will allow researchers to apply to the CSDR Independent Review Panel to gain access to the dataset for their own analyses."

https://mrc.ukri.org/news/browse/criticism-of-the-pace-trial/
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can someone follow this up.
 
Sly Saint said:
can someone follow this up.
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I did a quick search for PACE but the form is a bit awkward. Can't search by author and I'm not sure which terms were used. Nothing for CFS, which I assume is what would be used, and it's not even in the list of medical conditions.

But when there are no results there is an option to make an enquiry about the availability of data. Might it be worth the trouble?
 
https://www.clinicalstudydatarequest.com/Help/Help-Review-of-Requests.aspx

Here's a link to how requests are reviewed. Stage 1 is conducted by Wellcome Trust.

2. Stage 2 - The Study Sponsors/Funders check the following:
Sponsors/Funders generally review for the criteria below. Note that some Sponsors/Funders may opt out of a particular check. See individual Sponsor/Funder pages for details of each Sponsors/Funders' policies.

2.1 The Research Proposal is compatible with study informed consent
2.2 The data and studies are available to perform the analysis
2.3 The planned analysis can be conducted in the data access system
2.4 The Research Proposal does not compete with Sponsor/Funder's publication plan
2.5 Additional information that may be relevant to complete the review
This is generally to provide information to the researcher or for the researcher to provide additional information to the Sponsor/Funders, if clarification is needed
2.6 Under exceptional circumstance, for some Sponsors/Funders only - check for a potential conflict of interest or an actual or potential competitive risk
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Stage 3 is conducted by the Independent Review Panel, which is administered by Wellcome Trust.

Lots of room in Stage 2 for study sponsors/funders to deny requests for frivolous reasons.

E.T.A.-just to be clear, the denial is what I'm calling frivolous
 
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The data have now gone up on the site.
https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20098


I'm not sure what 'analysis ready dataset' means. 'Raw data' are not available.



MRC-G0200434


Study Funder: Medical Research Council

Study Title
PACE Trial - Pacing, Activity, and Cognitive behaviour therapy: a randomised clinical trial. A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy.

Medicine or Vaccine (generic name)
Adaptive pacing therapy (APT), cognitive behaviour therapy (CBT), graded exercise therapy (GET)

Funder Identification Number
G0200434

Trial Registry Identification Number(#'s)
ISRCTN54285094

Medical Condition
Chronic Fatigue Syndrome (CFS/ME)

Phase
N/A

Link to study details on the Medical Research Council Clinical Study Register
https://gtr.ukri.org/projects?ref=G0200434

Link to study details on ClinicalTrials.gov (if available)
https://doi.org/10.1186/ISRCTN54285094


Datasets and Documents Available for this Study
Protocol with any amendments
Analysis-ready dataset

Additional information about the data and documents available for this study
Once approved by the IRP, data will be provided on a remotely accessible secure data platform (UK SeRP, Swansea) including access to software for statistical analysis.

Date Added to this Site
November 2019
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JohnTheJack said:
I haven't communicated with him yet. I'm going to wait on the clarifications from the MRC that I have requested this afternoon.
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How many aeons will that take? Christmas is coming, then New Year, I bet they're all on holiday already. I imagine you won't get a sensible response before Mid January at the very earliest. Though obviously I hope I'm proved wrong.
 
ladycatlover said:
How many aeons will that take? Christmas is coming, then New Year, I bet they're all on holiday already. I imagine you won't get a sensible response before Mid January at the very earliest. Though obviously I hope I'm proved wrong.
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Yes, it's likely to be about then, especially as I have asked for some information that they may refuse to release and that could take some time to gather.
 
Lucibee said:
There doesn't seem to be any information about what variables are included in their "analysis ready" dataset.

The conditions for use are also quite stringent: https://www.clinicalstudydatarequest.com/Help/Help-Data-Sharing-Agreement.aspx
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Also the data release is very controlled in that if I understand correctly if you get the data you get access to it via an SAS cloud where you can do stats:
Provision of Data
Following receipt of a signed Data Sharing Agreement (DSA), Researchers are provided access to anonymized patient-level data and supporting documentation in a secure data access system, known as the SAS Clinical Trial Data Transparency (CTDT) system. Providing data through this system further safeguards the privacy of patients and helps to ensure that a Researcher’s use of the data adheres to the provisions contained within the signed Data Sharing Agreement (DSA). Some Sponsors (e.g. GSK) may provide data directly to Researchers where they are assured that the data will be secure – see the Sponsor specific pages for more information.

Access to data is provided for a 12-month period. Sponsors may extend access when justified for up to 24 months.

About the Clinical Trial Data Transparency (CTDT) System
The CTDT system is hosted by SAS and provides a secure research environment for Researchers to conduct their research.

Research teams are provided with a private research project area containing the anonymised patient level data and supporting documentation where they can create and run programs and store their outputs. This research project area is not accessed by Sponsors or other third parties unless Researchers request support. There are controls in place to prevent Researchers exporting the data and supporting documentation provided by a Sponsor. Researcher’s use of the data must adhere to the access and usage conditions required by SAS – SAS Terms of Use.
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I don't believe this is down to privacy of patients because if the data included any personal information then I would have thought they would be risking breaking DPA/GDPR by allowing such management and access. I.e. the data is being shared with third parties not specified and not within the bounds of any privacy agreement. I think the PACE information tribunal were clear on this when they shared patient level data with other groups.

So this is really about control over the data and results. It stops anyone with access doing speculative analysis.
 
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