Kings College Gives PACE Data To.....Someone

Cort

Founder of Health Rising and Phoenix Rising
Staff member
The Plot thickens. The PACE authors have sent the raw data to someone but to who? Apparently not the advocates requesting the data- we have not heard from them..and they stated that they declined the request from them - citing patient privacy. (Are the data really not anonymised?)

Posted on 18/12/2015

By investigators of the PACE trial:

"We have received many requests for access to individual patient data collected in the PACE trial.

We have supplied requested, anonymised data to independent scientists, as part of normal research collaboration. Among others, these include a Cochrane review group who have independently validated the trial findings on the primary outcomes, and who are now undertaking an individual patient data meta-analysis using these data.

We are however also concerned for the rights and welfare of trial participants. Participants did not give consent to the public release of their data when they entered the trial. In particular we are concerned to ensure that there is no risk of misuse of the data such as through inadvertent personal identification. The scientists who have already received data have all signed a formal confidentiality agreement, approved by the independent PACE Trial Steering Committee, which required that they respect the confidential nature of the data, and keep them secure, as agreed with trial participants when they consented to take part.

We stand by our decisions to decline two recent applications for trial data as we believe that they did not meet these requirements.

We are currently seeking further ethical and scientific advice, as well as the advice of patients, on how best to provide independent decisions about appropriate access to relevant data in a way that balances the rights of trial participants, and future progress of the trial analysis and follow up, with the public interest in releasing trial data."
 

Merry

Well-Known Member
Sasha points out in a comment on a James C. Coyne blog post http://linkis.com/wordpress.com/dbSUK that some patient data was in 2006 stolen. Those patients were not informed of the theft. The source she gives is page 256 of http://www.meactionuk.org.uk/magical-medicine.pdf .

That's rich that the PACE authors excuse for not handing over data is that they want to protect the rights of patients.

I can't remember -- if I ever knew -- what the Cochrane review group is. This group already "validated" the data, so how does giving it to them again answer those scientists, including Dr. Coyne, who have recently asked for the data? I guess the PACE researchers are saying that scientists outside the group of authors have already seen the data, so the latest requests are unreasonable.

Edit: Here's information at Wikipedia on the Cochrane organization:
Cochrane was founded in 1993 under the leadership of Iain Chalmers. It was developed in response to Archie Cochrane's call for up-to-date, systematic reviews of all relevant randomized controlled trials of health care.[9][10][11]

Cochrane's suggestion that the methods used to prepare and maintain reviews of controlled trials in pregnancy and childbirth should be applied more widely was taken up by the Research and Development Programme, initiated to support the United Kingdom's National Health Service. Through the NHS R&D programme, led by the first Director of Research and Development Professor Michael Peckham,[12] funds were provided to establish a "Cochrane Centre", to collaborate with others, in the UK and elsewhere, to facilitate systematic reviews of randomized controlled trials across all areas of health care.
 
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