Abstract

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

Highlights

  • El Comité Internacional de Editores de Revistas Médicas (ICMJE) considera que es una obligación ética compartir responsablemente los datos generados por ensayos clínicos, porque los participantes se han sometido a un riesgo particular

  • 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

  • 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

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Summary

Introduction

El Comité Internacional de Editores de Revistas Médicas (ICMJE) considera que es una obligación ética compartir responsablemente los datos generados por ensayos clínicos, porque los participantes se han sometido a un riesgo particular. 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. 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.

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