Open access Original research BMJ Open: first published as 10.1136/bmjopen-2021-049228 on 18 August 2021. Downloaded from Status, use and impact of sharing individual participant data from clinical trials: a scoping review Christian Ohmann ,1 David Moher ,2 Maximilian Siebert ,3 Edith Motschall ,4 Florian Naudet 5 To cite: Ohmann C, Moher D, ABSTRACT Strengths and limitations of this study Siebert M, et al. Status, Objectives To explore the impact of data- sharing use and impact of sharing initiatives on the intent to share data, on actual data ► Exhaustive review of both the literature and the main individual participant sharing, on the use of shared data and on research output data from clinical trials: a initiatives in data sharing. and impact of shared data. scoping review. BMJ Open ► Analysis of the full data- sharing process covering in- Eligibility criteria All studies investigating data- sharing 2021;11:e049228. doi:10.1136/ tention to share, actual sharing, use of shared data, practices for individual participant data (IPD) from clinical bmjopen-2021-049228 research output and impact. trials. ► Retrieval and synthesis of information proved to be ► Prepublication history and Sources of evidence We searched the Medline database, difficult because of a very siloed landscape where additional supplemental material the Cochrane Library, the Science Citation Index Expanded for this paper are available each initiative/platform operates with its own and the Social Sciences Citation Index via Web of Science, online. To view these files, metrics. and preprints and proceedings of the International please visit the journal online. ► Data sharing is a moving target in a rapidly changing Congress on Peer Review and Scientific Publication. In (http:// dx. doi. org/ 10. 1136/ environment with more and more new initiatives. bmjopen- 2021- 049228). addition, we inspected major clinical trial data- sharing ► Only a limited research output from data sharing is platforms, contacted major journals/publishers, editorial available so far. Received 20 January 2021 groups and some funders. ► The time from submitting a data- sharing request to Accepted 20 July 2021 Charting methods Two reviewers independently receiving the requested data was not systematically extracted information on methods and results from investigated in the review. resources identified using a standardised questionnaire. A map of the extracted data was constructed and accompanied by a narrative summary for each outcome discussion about clinical trial data sharing, http://bmjopen.bmj.com/ domain. the emphasis is naturally on the data sets Results 93 studies identified in the literature search © Author(s) (or their themselves, but data sharing is much broader. employer(s)) 2021. Re- use (published between 2001 and 2020, median: 2018) and 5 permitted under CC BY- NC. No from additional information sources were included in the Besides the individual participant data (IPD) commercial re- use. See rights scoping review. Most studies were descriptive and focused sets, other clinical trial data sources should and permissions. Published by on early phases of the data- sharing process. While the be made available for sharing (eg, proto- BMJ. willingness to share IPD from clinical trials is extremely cols, clinical study reports, statistical analysis 1 European Clinical Research high, actual data- sharing rates are suboptimal. A survey plans, blank consent forms) to enable a full Infrastructure Network, Paris, on September 27, 2021 by guest. Protected copyright. of journal data suggests poor to moderate enforcement of understanding of any data set. In this scoping France the policies by publishers. Metrics provided by platforms 2Ottawa Methods Centre, Ottawa review, there is a focus on the sharing of IPD suggest that a large majority of data remains unrequested. Hospital Research Institute, from clinical trials. Ottawa, Ontario, Canada When requested, the purpose of the reuse is more often Within clinical research, data sharing can 3 secondary analyses and meta-analyses, rarely re-analyses. CHU Rennes, CIC 1414 (Centre enhance reproducibility and the generation d'Investigation Clinique de Finally, studies focused on the real impact of data- sharing of new knowledge, but it also has an ethical Rennes), University Rennes, were rare and used surrogates such as citation metrics. 2 Rennes, France Conclusions There is currently a gap in the evidence and economic dimension. Scientifically, 4Institute of Medical Biometry base for the impact of IPD sharing, which entails sharing makes it possible to compare or and Statistics, Faculty of uncertainties in the implementation of current data- combine the data from different studies, and Medicine and Medical Center – sharing policies. High level evidence is needed to assess to more easily aggregate it for meta- analysis. University of Freiburg, Freiburg, whether the value of medical research increases with Baden- Württemberg, Germany It enables conclusions to be re- examined data- sharing practices. 5CHU Rennes, INSERM CIC 1414 and verified or, occasionally, corrected, and (Centre d'Investigation Clinique it can enable new hypotheses to be tested. de Rennes), University Rennes, Sharing can, therefore, increase data validity, Rennes, Bretagne, France INTRODUCTION but it also draws more value from the orig- Correspondence to Rationale inal research investment, as well as helping Professor Christian Ohmann; Data sharing is increasingly recognised as a to avoid unnecessary repetition of studies. christianohmann@ outlook. de key requirement in clinical research.1 In any Agencies and funders are referring more and Ohmann C, et al. BMJ Open 2021;11:e049228. doi:10.1136/bmjopen-2021-049228 1 Open access BMJ Open: first published as 10.1136/bmjopen-2021-049228 on 18 August 2021. Downloaded from more to the economic advantages of data reuse. Ethically, Data Access (YODA) (launched in 2011), Clin ical Stud data sharing provides a better way to honour the gener- yDat aRequest. com (CSDR) (launched in 2013), Vivli osity of clinical trial participants, because it increases the (launched in 2018). A considerable number of individual utility of the data they provide. Despite the high potential studies have been performed to access and explore the for sharing clinical trial data, the launch and implemen- sharing of data from clinical trials under different circum- tation of several data- sharing initiatives and platforms, stances and within different frameworks. What is strongly and outstanding examples related to the value of data needed is a scoping review providing an overview of the sharing,3 to date data sharing is not the norm in clinical status of implementation of data sharing as a whole and research, unlike many other scientific disciplines.4 One the implications originating from the available evidence. major hurdle is that clinical trial data concerns individ- uals and their health status, and as such requires specific Objectives measures to protect privacy. In this scoping review, we explored the impact of data- To support sharing of IPD in clinical trials, several sharing initiatives on the willingness to share data, the organisations have developed generic principles, guid- status of data sharing, the use of shared data and the ance and practical recommendations for implementa- impact of research outputs from shared data. tion. In 2016, the International Committee of Medical Journal Editors (ICMJE), a small group of medical journal editors, published an editorial stating that ‘it is METHODS an ethical obligation to responsibly share data gener- Protocol and registration ated by interventional clinical trials because participants The study protocol was registered on the Open Science have put themselves at risk’.5 The ICMJE considers that Framework on 12 September 2018 (registration number: there is an implicit social contract imposing an ethical osf.io/ pb8cj). The protocol followed the methodology obligation for the results to lead to the greatest possible manual published by the Joanna Briggs Institute for benefit to society. The ICMJE proposed to require that scoping reviews.12 Methods and results are reported using deidentified IPD is made publicly available no later than the Preferred Reporting Items for Systematic Reviews and 6 months after publication of the main trial results. This Meta Analyses extension for Scoping Reviews.13 time lapse would be useless for public health emergencies like COVID-19. However, the ICMJE proposal triggered Eligibility criteria debate, and a large number of trialists were reluctant to The following eligibility criteria for studies were used: adopt this new norm6 on account of the feasibility of the All study designs were eligible, including case studies, proposed requirements, the resources required, the real surveys, metrics and experimental studies, using qualita- or perceived risks to trial participants, and the need to tive or quantitative methods. Only published or unpub- protect the interests of patients and researchers.7 lished reports (eg, preprints, congress presentations, http://bmjopen.bmj.com/ Despite the cultural shift towards sharing clinical trial non- indexed information such as websites) in English, data and the major commitment of scientific organisa- German, French or Spanish were considered. tions, funders and initiatives, overall there is still a lack We included all studies and reports 1/providing infor- of effective policies in the biomedical literature to ensure mation on current IPD