Working Paper Concept Paper Version 1 This version is not peer-reviewed

Sharing of Data from Clinical Research Projects – Guidance from the Swiss CTU Network

Version 1 : Received: 27 June 2020 / Approved: 28 June 2020 / Online: 28 June 2020 (19:46:40 CEST)

How to cite: Gahl, B.; Haynes, A.; Sluka, C.; Dupuis-Lozeron, E.; Jörger, F.; Schur, R.; Christen, A.; Trelle, S. Sharing of Data from Clinical Research Projects – Guidance from the Swiss CTU Network. Preprints 2020, 2020060344 Gahl, B.; Haynes, A.; Sluka, C.; Dupuis-Lozeron, E.; Jörger, F.; Schur, R.; Christen, A.; Trelle, S. Sharing of Data from Clinical Research Projects – Guidance from the Swiss CTU Network. Preprints 2020, 2020060344


Objectives: Data sharing has become a requirement of many funding bodies and is becoming a scientific standard in many disciplines. In medical research, however, data sharing can conflict with clinicians’ obligation to protect patients’ privacy. General recommendations on data sharing exist also for clinical research, but so far lack practical and Swiss-specific aspects. The objective of this document is to provide practical recommendations for all relevant aspects of data sharing in agreement with legislation in Switzerland. Methods: This document was written by members of the Swiss CTU Network, a network of academic clinical trial units. The process did not follow a formalized Delphi process. After an internal consensus round, this report is now published as pre-print for external review. A second version will incorporate external comments. We plan to publish this document as a text in progress, as we expect relevant changes in related fields such as the development of further dedicated medical repositories or methodological advances in anonymization techniques. Results: We developed principles and practical recommendations with respect to informed consent, data management plan, anonymization, data structure and format, coding of variables, metadata and documentation, version control, selection of repository, requesting and use of data. We also provide a summary of legal aspects relevant for the Swiss context. Conclusions: The intension to share data has an impact not only after a clinical trial or an observational study is completed, but also during the planning period, the conduct and the analysis phase. Clinical researchers need to be aware at the beginning of a study on how to inform patients and at least the amount of work related to preparing data for sharing, metadata, and any further documentation. This report provides details of aspects to be considered, suggests decision criteria, and provides examples and checklists, in order to support data sharing in practice.

Subject Areas

clinical research; data sharing

Comments (1)

Comment 1
Received: 22 July 2020
Commenter: Christian Gluud
The commenter has declared there is no conflict of interests.
Comment: Gahl and colleagues have written a detailed guidance about sharing of data from clinical research projects on behalf of the Swiss CTU network. The manual gives detailed instructions and is separated into 14 chapters, a glossary, and appendices. The text is clear and informative and the recommendations rests on sound, pragmatic thinking. The text is written primarily to guide Swiss academic investigators but can be read by clinical investigators across the globe interested in the topic. I fully concur with the that detailed data sharing ought to be planned during the protocol writing of any piece of clinical research and be a prerequisite for ethical approval, data approval, and funding. I suggest the following amendments: 1. I think the whole background section in Abstract and Introduction needs some rewriting. The necessity of data sharing stems from the fact that a much too large proportion of clinical research is riddled by defects and shortcomings. Please read all the articles on waste in clinical research in The Lancet, then you will know why total data transparency is a must in clinical research. In a similar vein, I think that the correct reason for data sharing was not requests from funding bodies, but rather due to several individual researchers and The Cochrane Collaboration during the 1980 to 2000 period; the USA research infrastructure during the 2000 to 2007 period; the international medical journal editors 2005 onwards; and then some funding bodies. I think a clearer description of the historical development plus the difficulty of getting data sharing implemented as repeatedly reviled by the AllTrials campaign will make the necessity and importance of implementing the Swiss manual clearer. 2. Point 1 above also feeds into the fact, that the balance between data sharing on one hand and the risks following data sharing is a bit out of balance. Of course, data sharing of deidentified or anonymised data runs the risk of occasional reindentification of participants in clinical research. It is a feared harm of data sharing. However, compared to the benefits of being able to assess all data from clinical research then this harm should be considered minimal. Moreover, attempts to identify persons from deidentified or anonymised data ought to be a criminal offence in all countries. 3. I am not sure the argument in line 159 to 160 is fully correct. The vast majority of people entering randomised clinical trials do not benefit or get harmed from participation. A small group of trial participants will benefit and a small group will be harmed. Through proper and updated systematic reviews such harms shall of course be evaded as good as humanly possible. 4. I fully agree with the necessity to obtain data sharing both in all randomised and non-randomised clinical research. I think the authors should write a bit more on this in the background. 5. Line 221, please use participants in stead of subjects. The latter term is considered demeaning by many. 6. Line 319, reference 14 does not support the claim in the sentence. It shows that people disagree on definitions and this is causing contrasting views on legal and ethical aspects. Again, whenever risks of data sharing are mentioned, you need to stress the obvious advantages of data sharing. 7. All abbreviations should be written full out whenever used first time in each chapter. 8. Major part of the references need much more work.
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