Clinical trial data sharing statement

Research data
To ensure that no researcher or research sponsor is left without a solution to help draft a clinical trial data sharing statement (DSS). To promote responsible sharing of data from clinical trials.
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Responsible sharing of individual data from therapeutic trials can be a source of many opportunities for the scientific community as it enables re-analyses, secondary analyses, meta-analyses and other methodological developments. This requirement is even more important and urgent in the context of COVID-19 ((Ewers M, Ioannidis JPA, Plesnila N. Access to data from clinical trials in the COVID-19 crisis: open, flexible, and time-sensitive. Journal of clinical epidemiology. 2021;130:143-6. Epub 2020/10/18. doi: 10.1016/j.jclinepi.2020.10.008. PubMed PMID: 33068714; PubMed Central PMCID: PMCPMC7554475.)).

In 2016, the International Committee of Medical Journal Editors (ICMJE) ((The current members are Annals of Internal Medicine, British Medical Journal, Bulletin of the World Health Organization, German Medical Journal, Ethiopian Journal of Health Sciences, JAMA, Journal of Korean Medical Science, New England Journal of Medicine, New Zealand Medical Journal, The Lancet, Medical Journal of Chile, Danish Medical Journal, the U. S. National Library of Medicine, and the World Medical Writers Association.)) stated that responsible sharing of clinical trial data is an ethical obligation ((Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing Clinical Trial Data–A Proposal from the International Committee of Medical Journal Editors. N Engl J Med. 2016;374(4):384-6. Epub 2016/01/21. doi: 10.1056/NEJMe1515172 [doi]. PubMed PMID: 26786954.)). Those who take part in research accept to take risks for uncertain benefits and therefore it is only right that the value of the data collected should be maximised. Patients are also generally willing for their data to be shared ((Mello MM, Lieou V, Goodman SN. Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing. The New England journal of medicine. 2018;378(23):2202-11. Epub 2018/06/07. doi: 10.1056/NEJMsa1713258. PubMed PMID: 29874542; PubMed Central PMCID: PMCPMC6057615.)). Although the definitive ICMJE requirements do not make data sharing mandatory, they stipulate that a DSS must be included in every publication as of July 1st 2018 and that this should be specified in advance when registering the clinical trial as of January 1st 2019 ((Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors. PLoS Med. 2017;14(6):e1002315. Epub 2017/06/06. doi: 10.1371/journal.pmed.1002315 [doi]PMEDICINE-D-17-01550 [pii]. PubMed PMID: 28582414; PubMed Central PMCID: PMC5459581.)). The ICMJE is a large consortium, with over 5000 affiliated medical journals, which means these standards have a definite impact on the way research is published. Some journals, such as the BMJ and the PLOS group journals, have taken this further and require authors of therapeutic trials to share their data. These policies undoubtedly foreshadow the policies which will be adopted by all publishers in the future. Several research funders are planning to make data openness an eligibility criterion for projects in the years to come.

Currently however the implementation of this new standard has been somewhat disappointing ((Gaba JF, Siebert M, Dupuy A, Moher D, Naudet F. Funders’ data-sharing policies in therapeutic research: A survey of commercial and non-commercial funders. PloS one. 2020;15(8):e0237464. Epub 2020/08/21. doi: 10.1371/journal.pone.0237464. PubMed PMID: 32817724; PubMed Central PMCID: PMCPMC7446799)), ((Siebert M, Gaba JF, Caquelin L, Gouraud H, Dupuy A, Moher D, et al. Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations. BMJ open. 2020;10(5):e038887. Epub 2020/06/01. doi: 10.1136/bmjopen-2020-038887. PubMed PMID: 32474433; PubMed Central PMCID: PMCPMC7264700.)). Researchers are often difficult to contact, may lack the time and/or knowledge and/or technical infrastructure and/or financial resources to prepare and share their datasets ((Naudet F, Sakarovitch C, Janiaud P, Cristea I, Fanelli D, Moher D, et al. Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: survey of studies published in The BMJ and PLOS Medicine. Bmj. 2018;360:k400. Epub 2018/02/15. doi: 10.1136/bmj.k400. PubMed PMID: 29440066; PubMed Central PMCID: PMCPMC5809812.)). They may also face regulatory difficulties in sharing their data, as the definition of anonymisation is not universal, can be ambiguous and there is still a risk of loss of information involved ((Demotes-Mainard J, Cornu C, Guérin A. How the new European data protection regulation affects clinical research and recommendations? Therapie. 2019;74(1):31-42. Epub 2019/01/16. doi: 10.1016/j.therap.2018.12.004. PubMed PMID: 30642661.)).

The aim is to ensure that no researcher or research sponsor is left without a solution to help draft a clinical trial data sharing statement (DSS). The idea is to support researchers and sponsors at an early stage (before the research is submitted to the competent authorities) by providing them with various DSSs which are compatible with the RGPD, including both protocol elements and elements related to informing people who take part in the research.

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