YODA data release policy: data from Medtronic studies - message from Harlan Krumholz
Richard Lehman
I am writing you because you have expressed interest in the Yale University Open Data Access (YODA) Project and I want to alert you that we have posted a draft of a data release policy for public comment. The final policy will be used to guide our efforts to make Medtronic’s clinical trial data related to recombinant bone morphogenetic protein 2 (rhBMP-2) publicly available.
We have found that developing a policy that serves the public good and is attentive to possible unintended adverse consequences is not easy. Our goal is to promote use for scientific purposes – we do not want to be a gatekeeper – but we want policies that encourage constructive use recognizing that this move by Medtronic is unprecedented – and we would like it to spread – so we are trying to develop a model that will be used by others (and not necessarily with our involvement).
This draft policy is the result of work by our team and our Steering Committee. We also shared it with Medtronic and received comments from them. It is a work in progress, but we believe it is ready to share. To remind you, in our agreement with Medtronic, the Yale team has full authority to decide how the data will be made available – we consulted Medtronic because we wanted to hear their thoughts and we respect their opinions – but the decision is ours – and our Steering Committee have contributed comments – but they have not endorsed any policy yet and there are a variety of opinions that have been expressed.
To view this policy, please visit http://medicine.yale.edu/core/projects/yodap/medtronic_data/medtronic_data.aspx. We will be accepting comments until December 15, 2012, and anticipate announcing the final policy in January and will be putting the policies into practice soon after we release them. Please feel free to share this with colleagues. And again, this is a draft – we hope to take advantage of the wisdom of crowds and improve it before the final version. And even then, we believe it can continue to improve over time as we see how it is working.
Thank you for your consideration.
Best regards,
Harlan
Douglas Badenoch
Would you like me to publicise this on the IDEAL Collaboration website?
cheers
Douglas
-- Mr Douglas Badenoch Director, Minervation Ltd ------------------------- 23 Bonaly Grove Edinburgh EH13 0QB ------------------------- Tel: +44 131 441 4699 Web: www.minervation.com ------------------------- Minervation is a limited company registered in England and Wales Registered number: 4135916 VAT number: 792674384 Registered Office: Salter's Boat Yard, Folly Bridge, Abingdon Road, Oxford, OX1 4LB United Kingdom
Richard Lehman
Richard
Trish Groves
I'm sure the BMJ will respond, and we've noted the 15 December deadline. We're a bit preoccupied right now with writing a follow up editorial to flesh out the BMJ's new data sharing policy for clinical trials (requiring a commitment from BMJ authors to make patient level data available on reasonable request), and with preparing for 22 November's EMA meeting.
Meanwhile, have you seen this?
http://del-fi.org/post/35828082548/yoda-yada-yada
Best wishes
Trish
Dr Trish Groves
Deputy editor, BMJ
and Editor-in-chief, BMJ Open
+44 207 383 6018
bmj.com - the open access journal
bmjopen.bmj.com
BMJ Group: http://group.bmj.com
twitter @trished
Best regards,
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"Peter C. Gøtzsche"
thanks for alerting us to this website.
Harlan, I gave up responding to the proposal very quickly, as it is just way too far from anything I would be ready to accept, or even just to work on. My advice is: drop the idea and look to how the EMA in Europe currently thinks: no approvals, no committees, no constraints, access for everyone, please. This is what we mean by open society and this is also why the Glaxo inititative is not OK.
If companies don't want to share the data the patients have altruistically shared with the companies by running personal risks then boycott them, don't use their products. According to the European ombudsman, the companies don't own the data, society does!
bw
Peter
At 17:20 16-11-2012, Trish Groves wrote:
Thanks for sharing the draft policy.
I'm sure the BMJ will respond, and we've noted the 15 December deadline. We're a bit preoccupied right now with writing a follow up editorial to flesh out the BMJ's new data sharing policy for clinical trials (requiring a commitment from BMJ authors to make patient level data available on reasonable request), and with preparing for 22 November's EMA meeting.
Meanwhile, have you seen this?
http://del-fi.org/post/35828082548/yoda-yada-yada
Best wishes
Trish
Dr Trish Groves
Deputy editor, BMJ
and Editor-in-chief, BMJ Open
+44 207 383 6018
bmj.com - the open access journal
bmjopen.bmj.com
BMJ Group: http://group.bmj.com
twitter @trished
From: Richard Lehman <drricha...@gmail.com>
To: pathtodata...@googlegroups.com
Date: 08/11/2012 16:17
Subject: Re: YODA data release policy: data from Medtronic studies - message from Harlan Krumholz
Sent by: pathtodata...@googlegroups.com
Thanks Douglas - that would be great.
Richard
On Thu, Nov 8, 2012 at 11:16 AM, Douglas Badenoch < douglas....@minervation.com > wrote:
Thanks Richard
Would you like me to publicise this on the IDEAL Collaboration website?
cheers
Douglas
On 08/11/2012 16:11, Richard Lehman wrote:
I am writing you because you have expressed interest in the Yale University Open Data Access (YODA) Project and I want to alert you that we have posted a draft of a data release policy for public comment. The final policy will be used to guide our efforts to make Medtronic’s clinical trial data related to recombinant bone morphogenetic protein 2 (rhBMP-2) publicly available.
We have found that developing a policy that serves the public good and is attentive to possible unintended adverse consequences is not easy. Our goal is to promote use for scientific purposes – we do not want to be a gatekeeper – but we want policies that encourage constructive use recognizing that this move by Medtronic is unprecedented – and we would like it to spread – so we are trying to develop a model that will be used by others (and not necessarily with our involvement).
This draft policy is the result of work by our team and our Steering Committee. We also shared it with Medtronic and received comments from them. It is a work in progress, but we believe it is ready to share. To remind you, in our agreement with Medtronic, the Yale team has full authority to decide how the data will be made available – we consulted Medtronic because we wanted to hear their thoughts and we respect their opinions – but the decision is ours – and our Steering Committee have contributed comments – but they have not endorsed any policy yet and there are a variety of opinions that have been expressed.
To view this policy, please visit http://medicine.yale.edu/core/projects/yodap/medtronic_data/medtronic_data.aspx . We will be accepting comments until December 15, 2012, and anticipate announcing the final policy in January and will be putting the policies into practice soon after we release them. Please feel free to share this with colleagues. And again, this is a draft – we hope to take advantage of the wisdom of crowds and improve it before the final version. And even then, we believe it can continue to improve over time as we see how it is working.
Peter C. Gøtzsche, Professor, Director, MD, DrMedSci, MSc
Nordic Cochrane Centre, Rigshospitalet, Dept. 7811
e-mail: p...@cochrane.dk, Tel: +45 35 45 71 12, Fax: +45 35 45 70 07
____________________________
NEW BOOK:
Mammography screening: truth, lies and
controversy.
London: Radcliffe Publishing; 2012.
See
www.cochrane.dk
Featured, for example, in
The
Guardian
JAMA (16 May 2012) and BMJ (17 May 2012)
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Visiting address: Tagensvej 22, 1st floor
Vanamee, Eva
"Peter C. Gøtzsche"
What's wrong with the proposed new Regulation of the EU Clinical Trials Directive?
Informed consent
The Regulation requires that all information to the trial participants shall be submitted together with the form for written informed consent. This is important since, by making such information publicly available, it will be possible to judge whether companies live up to their obligations towards the trial participants. The consent form must state that the trial will be registered before recruitment of the first participant and that all results and anonymised trial data will be made publicly available within a year after the end of the trial at the EU portal.
bw
Peter
Bero, Lisa
Please see below comments that colleagues and I have posted regarding the YODA data access policy. According to the YODA website, although public comments are sought, these comments will not be posted .. which seems to defeat the purpose of public comment. Since we know this list is very open, I have posted here for those who are interested.
Lisa
START OF POSTED COMMENT
Thank you for the opportunity to review the policy and post comments. Our comments are posted from the perspective of academic researchers with a strong interest in data access. We believe access to data is important in order to have complete and accurate data on the benefits and harms of devices, drugs and other interventions, to detect selective outcome reporting and other biases, and to conduct accurate meta-analyses. None of the authors of this comment have any financial ties with any drug or device companies.
Purpose of the data access policy
1. The title of the policy is misleading as it does not describe “open data access” according to definitions used by Creative Commons or the Open Service Software Definition: “A piece of content or data is open if anyone is free to use, reuse, and redistribute it — subject only, at most, to the requirement to attribute and/or share-alike.”
In order to be truly open access, the full data should be available to the public.
2. The policy states that registration is required "to be able track the use of the data and measure the success of the program." However, this could easily be accomplished through a public website. It seems the real purpose is to ensure that the company has some control over making data available to law firms or competitors. While this is a business concern, it does not facilitate research by independent investigators.
Requirement for submission of a protocol in order to request data
3. Even with a defined protocol, it may be difficult to know what data to request if you don’t know the data exists. This seems similar to requesting data through a FOIA to a regulatory agency. The request has to be very specific and sometimes the investigator may not be able to anticipate every data point to be requested.
There will be less possibility to explore methodological issues with the data unless the entire data set for each study can be requested.
Publication / dissemination restrictions
4. The policy states that “The findings derived from analysis of the data will only be publicly disseminated through the peer-reviewed biomedical literature or a scientific meeting.”
This is an excellent goal, but in an open society, there should be no restrictions as to how the results will be disseminated, just as the EMA does not require this when allowing access to unpublished trial data. As just one example, the data would not be available to technology assessment agencies for their reports. See also what international organisations think about this, in: Gøtzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011;12(1):249.
5. The policy states, "In addition, any abstracts resulting from the proposed research will be required to be submitted to Yale" and "The investigator will provide the Yale team a copy of any manuscript generated from the data request, at the time of submission for publication. The Yale team will share this copy with Medtronic upon receipt."
This allows Medtronic and Yale to review publications at the time of submission. Pre-publication review of manuscripts is a tactic that has been used for decades by a variety of industries to influence scientific publication (eg, White, J, Bero, LA. Corporate manipulation of research: Strategies are similar across five industries, Stanford Law & Policy Review. 2010; 21(1):105-134). Even if the reviewers are not able to directly edit the manuscript, they could influence its review and / or the scientific discourse about the paper. There are also numerous examples of threats to researchers of litigation if the company doesn't like what it sees.
Data ownership
6. The policy states, “Medtronic is the rightful owner of the clinical trial data and makes it available for external use. The decision to provide access to the data will be made by the Yale team alone, without external input from Medtronic. Medtronic will honor the decision of the Yale team to provide data access and will enter into the data use agreement without further review of the data request application.” “The exact language of the DUA is yet to be drafted and will need to be negotiated between Yale University and Medtronic, but the following are expected to be included ….”
First, it is a terrible misconception that a company owns clinical trial data. According to the European ombudsman, data and results belong to society, for obvious reasons. Patients don't volunteer for trials and run a personal risk by so doing in order to benefit the shareholders of a particularly company. They do so in order to contribute to science and to help improve treatments for future patients. When companies claim ownership to trial data, they therefore say that it is legitimate to exploit patients for commercial benefit. It is not. Second, these requirements reiterate that this is not an open access policy. Furthermore, there is no time limit specified for the review of the protocols or finalizing the contracts. Negotiations of these contracts could be a very protracted process. Would it be possible for Medtronic and / or Yale to ask for repeated extensions of the negotiation? In effect, the delays could be so great that the data might be impossible to access. Again, there are numerous published examples of industry delaying tactics.
7. The policy states, "A certificate of data destruction within 30 days of the expiration date that is signed by the principal investigator will be required." As researchers, we must be accountable for the data in any studies we publish even after the study is published. We will be expected to answer queries concerning our studies at a later stage. This would not be possible if the researchers no longer have access to the data. At many institutions, there is a requirement that the data cannot be destroyed for at least 15 years, and nowadays, data should be kept indefinitely, which is easy on electronic media.
Lisa Bero, Ph.D.
Professor of Clinical Pharmacy and Health Policy
Vice Chair, Research
University of California, San Francisco
Director, San Francisco Branch, United States Cochrane Center
California, US
Peter C Gøtzsche
Professor, Director, MD, DrMedSci, MSc
Nordic Cochrane Centre
Rigshospitalet, Copenhagen
Denmark
Andreas Lundh
Researcher, MD, MSc
Nordic Cochrane Centre
Rigshospitalet, Copenhagen
Denmark
Jeppe Schroll
Phd student, MD
The Nordic Cochrane Centre
Copenhagen, Denmark
Joel Lexchin MD
Professor
School of Health Policy and Management
Faculty of Health
York University
Toronto, Canada
Nicole Wolfe PhD
Assistant Adjunct Professor
Dept of Social and Behavioral Sciences
University of California, San Francisco
California, US
Lisa A. Bero, Ph.D.
Professor
University of California, San Francisco
Suite 420, Box 0613
3333 California Street
San Francisco, CA 94118 USA
Phone: 415-476-1067
Fax: 415-502-0792
Ross, Joseph
Lisa, thanks to you and the other named individuals for submitting these comments.
In fact, many thanks to many from the PATH group – a number of you have submitted comments which we believe can be used to strengthen our policy.
I just wanted to clarify, we do intend to post summary comments and our response as we finalize our policy for data access and release, although we will not name individuals who submitted each comment. By public comment, we meant comment from the wider public. We did not secure permission for public posting of submitted comments.
Joe Ross
Bero, Lisa
Great.. thanks for that clarification.. It will be interesting to see the variety of comments I am sure you are receiving.
Lisa
Lisa A. Bero, Ph.D.
Professor
University of California, San Francisco
Suite 420, Box 0613
3333 California Street
San Francisco, CA 94118 USA
Phone: 415-476-1067
Fax: 415-502-0792