SharingClinicalTrialData:AProposalFromtheInternational ...

1 Annals of Internal Medicine EDITORIAL. Sharing Clinical Trial Data: A Proposal From the international Committee of Medical journal Editors T he international Committee of Medical journal Editors (ICMJE) believes that there is an ethical ob- ligation to responsibly share data generated by inter- added an element to its registration platform to collect data-sharing plans. We encourage other trial registries to similarly incorporate mechanisms for the registration ventional clinical trials because participants have put of data-sharing plans. Trialists who want to publish in themselves at risk. In a growing consensus, many ICMJE member journals (or nonmember journals that funders around the world foundations, government choose to follow these recommendations) should agencies, and industry now mandate data sharing.

2 Choose a registry that includes a data-sharing plan ele- Here we outline ICMJE's proposed requirements to ment as a speci ed registry item or allows for its entry help meet this obligation. We encourage feedback on as a free-text statement in a miscellaneous registry the proposed requirements. Anyone can provide feed- eld. As a condition of consideration for publication in back at by 18 April 2016. our member journals, authors will be required to in- The ICMJE de nes a clinical trial as any research clude a description of the data-sharing plan in the sub- project that prospectively assigns people or a group of mitted manuscript.

3 Authors may choose to share the people to an intervention, with or without concurrent deidenti ed IPD underlying the results presented in the comparison or control groups, to study the cause-and- article under less restrictive, but not more restrictive, effect relationship between a health-related interven- conditions than were indicated in the registered data- tion and a health outcome. Further details may be sharing plan. found in the Recommendations for the Conduct, Re- ICMJE already requires the prospective registra- porting, Editing and Publication of Scholarly Work in tion of all clinical trials prior to enrollment of the rst Medical Journals at participant.

4 This requirement aims, in part, to prevent As a condition of consideration for publication of a selective publication and selective reporting of re- clinical trial report in our member journals, the ICMJE search outcomes, and to prevent unnecessary duplica- proposes to require authors to share with others the tion of research effort. Including a commitment to a deidenti ed individual-patient data (IPD) underlying data-sharing plan is a logical addition to trial registra- the results presented in the article (including tables, g- tion that will further each of these goals. Prospective ures, and appendices or supplementary material) no trial registration currently includes documenting the later than 6 months after publication.

5 The data under- planned primary and major secondary end points to lying the results are de ned as the IPD required to re- be assessed, which enables identi cation of incom- produce the article's ndings, including necessary plete reporting as well as post hoc analyses. Declaring metadata. This requirement will go into effect for the plan for sharing data prior to their collection will clinical trials that begin to enroll participants beginning further enhance transparency in the conduct and re- 1 year after the ICMJE adopts its data-sharing porting of clinical trials by exposing when data avail- requirements.* ability following trial completion differs from prior Enabling responsible data sharing is a major en- commitments.

6 Deavor that will affect the fabric of how clinical trials are Sharing clinical trial data, including deidenti ed planned and conducted and how their data are used. IPD, requires planning to ensure appropriate ethics By changing the requirements of the manuscripts we committee or institutional review board approval and will consider for publication in our journals, editors can the informed consent of study participants. Accord- help foster this endeavor. As editors, our direct in u- ingly, we will defer these requirements for 1 year to ence is logically, and practically, limited to those data allow investigators, trial sponsors, and regulatory bod- underpinning the results and analyses we publish in ies time to plan for their implementation.

7 Our journals. Just as the con dentiality of trial participants must The ICMJE also proposes to require that authors be protected (through the deidenti cation of IPD), and include a plan for data sharing as a component of clin- the needs of those reasonably requesting data met ical trial registration. This plan must include where the (through the provision of useable data), the reasonable researchers will house the data and, if not in a public rights of investigators and trial sponsors must also be repository, the mechanism by which they will provide protected. ICMJE proposes the following to safeguard others access to the data, as well as other data-sharing these rights.

8 First, ICMJE editors will not consider the plan elements outlined in the 2015 Institute of Medi- deposition of data in a registry to constitute prior pub- cine Report ( , whether data will be freely available lication. Second, authors of secondary analyses using to anyone upon request or only after application to and these shared data must attest that their use was in ac- approval by a learned intermediary, whether a data use cordance with the terms (if any) agreed to upon their agreement will be required) (1). has receipt. Third, they must reference the source of the This article was published at on 26 January 2016. * The ICMJE plans to adopt data-sharing requirements after considering feedback received to the proposals made here.

9 Annals of Internal Medicine 1. EDITORIAL Sharing Clinical Trial Data data using a unique identi er of a clinical trial's data set Jeffrey M. Drazen, MD, Editor-in-Chief, New England journal to provide appropriate credit to those who generated it of Medicine and allow searching for the studies it has supported. John Fletcher, MB, BChir, MPH, Editor-in-Chief, Canadian Fourth, authors of secondary analyses must explain Medical Association journal completely how theirs differ from previous analyses. In Frank A. Frizelle, MBChB, FRACS, Editor-in-Chief, addition, those who generate and then share clinical New Zealand Medical journal trial data sets deserve substantial credit for their efforts.

10 Trish Groves, MBBS, MRCP sych, Head of Research, British Those using data collected by others should seek col- Medical journal laboration with those who collected the data. However, Abraham Haileamlak, MD, Editor-in-Chief, Ethiopian journal because collaboration will not always be possible, prac- of Health Sciences tical, or desired, an alternative means of providing ap- Astrid James, MBBS, Deputy Editor, The Lancet propriate credit needs to be developed and recog- Christine Laine, MD, MPH, Editor-in-Chief, Annals of Internal nized in the academic community. We welcome ideas Medicine about how to provide such credit. Larry Peiperl, MD, Chief Editor, PLOS Medicine Data sharing is a shared responsibility.