EDITORIAL - Data Sharing Statements forClinical Trials: A Requirement of theInternational Committee of MedicalJournal Editors

Junio 2017

EDITORIAL 691 Rev Med Chile 2017; 145: 691-693 Data Sharing Statements for Clinical Trials: A Requirement of the International Committee of Medical Journal Editors Darren B. Taichman, MD, PhD1, Peush Sahni, MB, BS, MS, PhD2, Anja Pinborg, MD3, Larry Peiperl, MD4, Christine Laine, MD, MPH5, Astrid James, MB, BS6, Sung-Tae Hong, MD, PhD7, Abraham Haileamlak, MD8, Laragh Gollogly, MD, MPH9, Fiona Godlee, FRCP10, Frank A. Frizelle, MB, ChB, FRACS11, Fernando Florenzano, MD12, Jeffrey M. Drazen, MD13, Howard Bauchner, MD14, Christopher Baethge, MD15, Joyce Backus, MSLS16 Declaración sobre compartir datos: un requerimiento del Comité Internacional de Editores de Revistas Médicas El Comité Internacional de Editores de Revista Médicas (ICMJE) ha tomado la posición que el compartir los datos generados por los ensayos clínicos es una obligación ética, por cuanto los participantes en esos estudios se colocaron en riesgo al aceptar su inclusión. En esta editorial el ICMJE expresa que requerirá desde Julio 2018 que los manuscritos enviados a sus revistas deben incluir una declaración sobre compartir datos. A su vez, los ensayos clínicos que comiencen a enrolar pacientes a partir de Enero 2019, deben incluir un plan sobre compartir datos en el registro de tales ensayos. Se dan en esta declaración cuatro ejemplos de declaraciones sobre compartir datos, referidos a qué datos se compartirán, cuándo estarán disponibles y qué criterios de acceso se establecerán. El ICMJE visualiza un futuro cercano en el cual el compartir los datos será la norma, con el fin de maximizar el conocimiento ganado por los esfuerzos y sacrificios de los participantes. 1Secretary, ICMJE, Executive Deputy Editor, Annals of Internal Medicine. 2Representative and Past President, World Association of Medical Editors. 3Scientific Editor-in-Chief, Ugeskrift for Laeger (Danish Medical Journal). 4Chief Editor, PLOS Medicine. 5Editor-in-Chief, Annals of Internal Medicine. 6Deputy Editor, The Lancet. 7Editor-in-Chief, Journal of Korean Medical Science. 8Editor-in-Chief, Ethiopian Journal of Health Sciences. 9Editor, Bulletin of the World Health Organization, Coordinator, WHO Press. 10Editor-in-Chief, The BMJ (British Medical Journal). 11Editor-in-Chief, New Zealand Medical Journal. 12Editor, Revsita Médica de Chile (Medical Journal of Chile). 13Editor-in-Chief, New England Journal of Medicine. 14Editor-in-Chief, JAMA (Journal of the American Medical Association) and the JAMA Network. 15Chief Scientific Editor, Deutsches Ärzteblatt (German Medical Journal) & Deutsches Ärzteblatt International. 16Representative and Associate Director for Library Operations, National Library of Medicine. The International Committee of Medical Journal Editors (ICMJE) believes there is an ethical obligation to responsibly share data generated by interventional clinical trials because trial participants have put themselves at risk. In January 2016 we published a proposal aimed at helping to create an environment in which the sharing of deidentified individual participant data becomes the norm. In response to our request for feedback we received many comments from individuals and groups1. Some applauded the proposals while others expressed disappointment they did not more quickly create a commitment to data sharing. Many raised valid concerns regarding the feasibility of the proposed requirements, the necessary resources, the real or perceived risks to trial participants, and the need to protect the interests of patients and researchers. It is encouraging that data sharing is already occurring in some settings. Over the past year, however, we have learned that the challenges are substantial and the requisite mechanisms are not in place to mandate universal data sharing at this time. Although many issues must be addressed


Junio 2017
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