Joyce Backus

Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world — foundations, government agencies, and industry — now mandate data sharing. Here we outline the ICMJE’s proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by 18 April 2016. The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome. Further details may be found in the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals at www.icmje.org. As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individualpatient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. The data underlying the results are defined as the IPD required to reproduce the article’s findings, including necessary metadata. This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements. (The ICMJE plans to adopt data-sharing requirements after considering feedback received to the proposals made here.) Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used. By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor. As editors, our direct influence is logically, and practically, limited to those data underpinning the results and analyses we publish in our journals. The ICMJE also proposes to require that authors include a plan for data sharing as a component of clinical trial registration. This plan must include where the researchers will house the data and, if not in a public repository, the mechanism by which they will provide others access to the data, as well as other data-sharing plan elements outlined in the 2015 Institute of Medicine Report (e.g., whether data will be freely available to anyone upon request or only after application to and approval by a learned intermediary, whether a data use agreement will be required).1 ClinicalTrials.gov has added an element to its registration platform to collect datasharing plans. We encourage other trial registries to similarly incorporate mechanisms for the registration of data-sharing plans. Trialists who want to publish in ICMJE member journals (or nonmember journals that choose to follow these recommendations) should choose a registry that includes a data-sharing plan element as a specified registry item or allows for its entry as a free-text statement in a miscellaneous registry field. As a condition of consideration for publication in our member journals, authors will be

Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors

In a joint publication across 14 member journals, the International Committee of Medical Journal Editors (ICMJE) proposes to require sharing of deidentified individual patient data underlying published clinical trials.

Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world—foundations, government agencies, and industry—now mandate data sharing. Here we outline ICMJE’s proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by April 18, 2016.

Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors

Committee of Medical Journal Editors T International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world—foundations, government agencies, and industry—now mandate data sharing. Here we outline ICMJEs proposed requirements to help meet this obligation. We encourage feedback on the proposed requirements. Anyone can provide feedback at www.icmje.org by 18 April 2016. The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-andeffect relationship between a health-related intervention and a health outcome. Further details may be found in the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals at www.icmje.org. As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. The data underlying the results are defined as the IPD required to reproduce the articles findings, including necessary metadata. This requirement will go into effect for clinical trials that begin to enroll participants beginning 1 year after the ICMJE adopts its data-sharing requirements.* Enabling responsible data sharing is a major endeavor that will affect the fabric of how clinical trials are planned and conducted and how their data are used. By changing the requirements of the manuscripts we will consider for publication in our journals, editors can help foster this endeavor. As editors, our direct influence is logically, and practically, limited to those data underpinning the results and analyses we publish in our journals. The ICMJE also proposes to require that authors include a plan for data sharing as a component of clinical trial registration. This plan must include where the researchers will house the data and, if not in a public repository, the mechanism by which they will provide others access to the data, as well as other data-sharing plan elements outlined in the 2015 Institute of Medicine Report (e.g., whether data will be freely available to anyone upon request or only after application to and approval by a learned intermediary, whether a data use agreement will be required) (1). ClinicalTrials.gov has added an element to its registration platform to collect data-sharing plans. We encourage other trial registries to similarly incorporate mechanisms for the registration of data-sharing plans. Trialists who want to publish in ICMJE member journals (or nonmember journals that choose to follow these recommendations) should choose a registry that includes a data-sharing plan element as a specified registry item or allows for its entry as a free-text statement in a miscellaneous registry field. As a condition of consideration for publication in our member journals, authors will be required to include a description of the data-sharing plan in the submitted manuscript. Authors may choose to share the deidentified IPD underlying the results presented in the article under less restrictive, but not more restrictive, conditions than were indicated in the registered datasharing plan. ICMJE already requires the prospective registration of all clinical trials prior to enrollment of the first participant. This requirement aims, in part, to prevent selective publication and selective reporting of research outcomes, and to prevent unnecessary duplication of research effort. Including a commitment to a data-sharing plan is a logical addition to trial registration that will further each of these goals. Prospective trial registration currently includes documenting the planned primary and major secondary end points to be assessed, which enables identification of incomplete reporting as well as post hoc analyses. Declaring the plan for sharing data prior to their collection will further enhance transparency in the conduct and reporting of clinical trials by exposing when data availability following trial completion differs from prior commitments. Sharing clinical trial data, including deidentified IPD, requires planning to ensure appropriate ethics committee or institutional review board approval and the informed consent of study participants. Accordingly, we will defer these requirements for 1 year to allow investigators, trial sponsors, and regulatory bodies time to plan for their implementation. Just as the confidentiality of trial participants must be protected (through the deidentification of IPD), and the needs of those reasonably requesting data met (through the provision of useable data), the reasonable rights of investigators and trial sponsors must also be protected. ICMJE proposes the following to safeguard these rights. First, ICMJE editors will not consider the deposition of data in a registry to constitute prior publication. Second, authors of secondary analyses using these shared data must attest that their use was in accordance with the terms (if any) agreed to upon their receipt. Third, they must reference the source of the

Data sharing statements for clinical trials

A requirement of the International Committee of Medical Journal Editors

Characteristics of project management at institutions sponsoring National Library of Medicine MedlinePlus Go Local

OBJECTIVES Through interviews with the National Library of Medicines MedlinePlus Go Local collaborators, an evaluation team sought to identify process characteristics that are critical for long-term sustainability of Go Local projects and to describe the impact that Go Local projects have on sponsoring institutions. METHODS Go Local project coordinators (n = 44) at 31 sponsor institutions participated in semi-structured interviews about their experiences developing and maintaining Go Local sites. Interviews were summarized, checked for accuracy by the participating librarians, and analyzed using a general inductive methodology. RESULTS Institutional factors that support Go Local projects were identified through the interviews, as well as strategies for staffing and partnerships with external organizations. Positive outcomes for sponsoring institutions also were identified. CONCLUSIONS The findings may influence the National Library of Medicine teams decisions about improvements to its Go Local system and the support it provides to sponsoring institutions. The findings may benefit current sponsoring institutions as well as those considering or planning a Go Local project.

Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors

The International Committee of Medical Journal Editors announces requirements that a data sharing plan be prospectively registered, and a data sharing statement be included in submitted manuscripts, for clinical trials to be published in ICMJE journals.

Organizing Electronic Information to Serve the Needs of Health Practitioners and Customers

From its beginnings as the Library of the Army Surgeon General to todays Internet-driven information environment, the U.S. National Library of Medicine (NLM) has served a variety of audiences. As NLM strives to provide the best possible service to health scientists and consumers, the form of that service has changed depending on resources available and the state of technology. Throughout its history, NLM has adopted innovative programs and technology at the earliest sensible moment that would serve its patron needs. Today, NLM is a leader in providing electronic biomedical information to health professionals, researchers, the public, and anyone else with access to the Internet. These services have evolved in response to available technology and the demands of the various audiences, from clinicians to consumers. To serve the needs of this variety of patrons, NLM connects health information resources in ways that enable each audience to find the information appropriate to its need. NLM continues to improve this organization as the demand and technology and resources allow.

Examining the role of MEDLINE as a patient care information resource: an analysis of data from the Value of Libraries study

Objective: This study analyzed data from a study on the value of libraries to understand the specific role that the MEDLINE database plays in relation to other information resources that are available to health care providers and its role in positively impacting patient care. Methods: A previous study on the use of health information resources for patient care obtained 16,122 responses from health care providers in 56 hospitals about how providers make decisions affecting patient care and the role of information resources in that process. Respondents indicated resources used in answering a specific clinical question from a list of 19 possible resources, including MEDLINE. Study data were examined using descriptive statistics and regression analysis to determine the number of information resources used and how they were used in combination with one another. Results: Health care professionals used 3.5 resources, on average, to aid in patient care. The 2 most frequently used resources were journals (print and online) and the MEDLINE database. Using a higher number of information resources was significantly associated with a higher probability of making changes to patient care and avoiding adverse events. MEDLINE was the most likely to be among consulted resources compared to any other information resource other than journals. Conclusions: MEDLINE is a critical clinical care tool that health care professionals use to avoid adverse events, make changes to patient care, and answer clinical questions.

Compartir los datos de los ensayos clínicos: una propuesta del Comité Internacional de Editores de Revistas Médicas

El Comite Internacional de Editores de Revistas Me-dicas (ICMJE, por sus siglas en ingles) considera que es una obligacion etica compartir, de forma respon- sable, los datos generados por los ensayos clinicos, porque los participantes se han puesto en riesgo para ello.El Comite Internacional de Editores de Revistas Medicas (ICMJE) considera que es una obligacion etica compartir responsablemente los datos generados por ensayos clinicos, porque los participantes se han sometido a un riesgo particular. En un consenso creciente, muchos patrocinadores en el mundo -Fundaciones, Agencias Gubernamentales y la industria proveedora en salud- ya exigen compartir los datos. Por este motivo, en esta Editorial, que sera publicada simultaneamente en enero de 2016 por las revistas que a la fecha integran el ICMJE, dicho Comite propone requerir a los autores de ensayos clinicos que compartan con otros los datos individuales, anonimos, que generaron los resultados que se presentan en el manuscrito enviado a publicacion (incluyendo Tablas, Figuras y anexos o material suplementario) en un plazo menor a seis meses despues de su publicacion. Se define como “datos que generaron los resultados” a los datos individuales de cada paciente (anonimos) que se requieren para reproducir los hallazgos que muestra el manuscrito, incluyendo sus metadatos. Este requisito sera aplicado a los ensayos clinicos que comiencen a reclutar pacientes desde un ano despues que el ICMJE adopte como requisito compartir los datos, lo que ocurrira despues de considerar el “feedback” que se reciba al difundir esta Editorial. El documento original, que se reproduce a continuacion, reitera la definicion de “ensayo clinico” y explicita la forma y condiciones que propone para cumplir con este requisito.