DataSharingStatementsforClinicalTrials:ARequirementofthe ...

1 Annals of Internal Medicine EDITORIAL. Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors T he International Committee of Medical Journal Edi- tors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional ples of data sharing statements that would meet these requirements are in the Table. These initial requirements do not yet mandate data clinical trials because trial participants have put them- sharing, but investigators should be aware that editors selves at risk. In January 2016 we published a proposal may take into consideration data sharing statements aimed at helping to create an environment in which the when making editorial decisions. These minimum re- sharing of deidenti ed individual participant data be- quirements are intended to move the research enter- comes the norm. In response to our request for feed- prise closer to ful lling our ethical obligation to partic- back we received many comments from individuals ipants.

2 Some ICMJE member journals already maintain, and groups (1). Some applauded the proposals while or may choose to adopt, more stringent requirements others expressed disappointment they did not more for data sharing. quickly create a commitment to data sharing. Many Sharing clinical trial data is one step in the process raised valid concerns regarding the feasibility of the articulated by the World Health Organization (WHO). proposed requirements, the necessary resources, the and other professional organizations as best practice real or perceived risks to trial participants, and for clinical trials: universal prospective registration;. the need to protect the interests of patients and public disclosure of results from all clinical trials (includ- researchers. ing through journal publication); and data sharing. Al- It is encouraging that data sharing is already occur- though universal compliance with the requirement to ring in some settings.

3 Over the past year, however, we prospectively register clinical trials has not yet been have learned that the challenges are substantial and achieved and requires continued emphasis, we must the requisite mechanisms are not in place to mandate work toward ful lling the other steps of best practice as well including data sharing. universal data sharing at this time. Although many is- As we move forward into this new norm where data sues must be addressed for data sharing to become are shared, greater understanding and collaboration the norm, we remain committed to this goal. among funders, ethics committees, journals, trialists, Therefore, ICMJE will require the following as con- data analysts, participants, and others will be required. ditions of consideration for publication of a clinical trial We are currently working with members of the research report in our member journals: community to facilitate practical solutions to enable 1. As of 1 July 2018 manuscripts submitted to data sharing.

4 The United States Of ce for Human Re- ICMJE journals that report the results of clinical trials search Protections has indicated that provided the ap- must contain a data sharing statement as described propriate conditions are met by those receiving them, below. the sharing of deidenti ed individual participant data 2. Clinical trials that begin enrolling participants on from clinical trials does not require separate consent or after 1 January 2019 must include a data sharing from trial participants (2). Speci c elements to enable plan in the trial's registration. The ICMJE's policy re- data sharing statements that meet these requirements garding trial registration is explained at have been adopted at (https://prsinfo .org/recommendations/browse/publishing-a nd-editorial . #shareData). The WHO. - If the data sharing also supports the addition of such elements at the pri- plan changes after registration this should be re ected mary registries of the International Clinical Trials Regis- in the statement submitted and published with the try Platform.

5 Unresolved issues remain, including ap- manuscript, and updated in the registry record. propriate scholarly credit to those who share data, and Data sharing statements must indicate the follow- the resources needed for data access, the transparent ing: whether individual deidenti ed participant data processing of data requests, and data archiving. We (including data dictionaries) will be shared; what data welcome creative solutions to these problems at www in particular will be shared; whether additional, related . documents will be available ( , study protocol, statis- We envision a global research community in which tical analysis plan, etc.); when the data will become sharing deidenti ed data becomes the norm. Working available and for how long; by what access criteria data toward this vision will help maximize the knowledge will be shared (including with whom, for what types of gained from the efforts and sacri ces of clinical trial analyses, and by what mechanism).

6 Illustrative exam- participants. This article was published at on 6 June 2017. Annals of Internal Medicine 1. EDITORIAL Data Sharing Statements for Clinical Trials: A Requirement of the ICMJE. Table. Examples of Data Sharing Statements That Ful ll These ICMJE Requirements*. Example 1 Example 2 Example 3 Example 4. Will individual participant Yes Yes Yes No data be available (including data dictionaries)? What data in particular All of the individual Individual participant data Individual participant data that Not available will be shared? participant data collected that underlie the results underlie the results during the trial, after reported in this article, reported in this article, after deidenti cation. after deidenti cation deidenti cation (text, tables, (text, tables, gures, gures, and appendices). and appendices). What other documents Study Protocol, Statistical Study Protocol, Statistical Study Protocol Not available will be available?

7 Analysis Plan, Informed Analysis Plan, Analytic Consent Form, Clinical Code Study Report, Analytic Code When will data be Immediately following Beginning 3 months and Beginning 9 months and Not applicable available (start and end publication. No end date. ending 5 years ending 36 months following dates)? following article article publication. publication. With whom? Anyone who wishes to access Researchers who provide Investigators whose proposed Not applicable the data. a methodologically use of the data has been sound proposal. approved by an independent review committee ( learned intermediary ) identi ed for this purpose. For what types of Any purpose. To achieve aims in the For individual participant data Not applicable analyses? approved proposal. meta-analysis. By what mechanism will Data are available inde nitely Proposals should be Proposals may be submitted Not applicable data be made at (Link to be included). directed to To up to 36 months following available?

8 Gain access, data article publication. After 36. requestors will need to months the data will be sign a data access available in our University's agreement. Data are data warehouse but without available for 5 years at a investigator support other third party website (Link than deposited metadata. to be included). Information regarding submitting proposals and accessing data may be found at (Link to be provided). * These examples are meant to illustrate a range of, but not all, data sharing options. Darren B. Taichman, MD, PhD, Secretary, ICMJE, Executive Jeffrey M. Drazen, MD, Editor-in-Chief, New England Journal Deputy Editor, Annals of Internal Medicine of Medicine Peush Sahni, MBBS, MS, PhD, Representative and Past Howard Bauchner, MD, Editor-in-Chief, JAMA (Journal of the President, World Association of Medical Editors American Medical Association) and the JAMA Network Anja Pinborg, MD, Scienti c Editor-in-Chief, Ugeskrift for Christopher Baethge, MD, Chief Scienti c Editor, Deutsches Laeger (Danish Medical Journal) A rzteblatt (German Medical Journal) & Deutsches Larry Peiperl, MD, Chief Editor, PLOS Medicine A rzteblatt International Christine Laine, MD, MPH, Editor-in-Chief, Annals of Internal Joyce Backus, MSLS, Representative and Associate Director Medicine for Library Operations, National Library of Medicine Astrid James, MBBS, Deputy Editor, The Lancet Note.

9 This article is being published simultaneously in Annals Sung-Tae Hong, MD, PhD, Editor-in-Chief, Journal of Korean of Internal Medicine, BMJ (British Medical Journal), Bulletin of Medical Science the World Health Organization, Deutsches A rzteblatt (German Abraham Haileamlak, MD, Editor-in-Chief, Ethiopian Journal Medical Journal), Ethiopian Journal of Health Sciences, JAMA. of Health Sciences (Journal of the American Medical Association), Journal of Ko- Laragh Gollogly, MD, MPH, Editor, Bulletin of the World rean Medical Science, New England Journal of Medicine, New Health Organization, Coordinator, WHO Press Zealand Medical Journal, PLOS Medicine, The Lancet, Revista Fiona Godlee, FRCP, Editor-in-Chief, The BMJ Me dica de Chile (Medical Journal of Chile), and Ugeskrift for (British Medical Journal) Laeger (Danish Medical Journal). Frank A. Frizelle, MBChB, FRACS, Editor-in-Chief, Disclaimer: Dr. Sahni's af liation as representative and past New Zealand Medical Journal president of the World Association of Medical Editors (WAME).

10 Fernando Florenzano, MD, Editor, Revista Me dica de Chile does not imply endorsement by WAME member journals that (Medical Journal of Chile) are not part of the ICMJE. 2 Annals of Internal Medicine Data Sharing Statements for Clinical Trials: A Requirement of the ICMJE EDITORIAL. Disclosures: Disclosures can be viewed at References /authors/icmje/Con 1. Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing clinical trial data: a proposal from the In- ternational Committee of Medical Journal Editors [Editorial]. Ann In- Corresponding Author: Darren B. Taichman, MD, PhD, Amer- tern Med. 2016;164:505-6. [PMID: 26792258] ican College of Physicians, 190 N. Independence Mall West, -2928. Philadelphia, PA 19106; e-mail, 2. Menikoff J. Letter from Jerry Menikoff, MD, JD, Director, Of ce for Human Research Protections, to ICMJE Secretariat. 7 March 2017. Accessed at Ann Intern Med. Annals of Internal Medicine 3.