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

Abstract

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 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. † 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.

Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors´ Network

“…Razmjena podataka iz kliničkih ispitivanja: novi prijedlog Međunarodnog odbora urednika medicinskih časopisa ICMJE smatra da je moralna obvezna odgovorno dijeliti podatke dobivene u kliničkim ispitivanjima 14 . Ideja na kojoj se temelji ovaj globalni pothvat jest da pacijenti preuzimaju rizik time što prihvaćaju sudjelovanje u kliničkom ispitivanju.…”

“…Stoga je javno objavljivanje prikupljenih podataka odgovorna inicijativa za olakšanje napretka znanosti. Razmjena bi podataka povećala povjerenje u rezultate neovisnih istraživanja 14 . Usto, različite skupine istraživača mogu istraživati nove hipoteze.…”

“…Ako znanost postane "otvoreni" proces, mnogi će istraživači imati koristi od uporabe pouzdanih podataka prikupljenih negdje drugdje. Stoga se razmjena podataka pokazala kao najbolji način osiguranja da sve informacije prikupljene u kliničkim ispitivanjima budu slobodno i široko raspoložive kako bi se mogle lako iskoristiti za unaprjeđivanje istraživačkog znanja 14 . Uporaba prethodno prikupljenih podataka kako bi se postigao daljnji razvoj znanosti koncept je koji nije lako kritizirati.…”

“…However, transparency also represents a major tenet in the scientific process 5-8 . This review will discuss the new editorial recommendations on data sharing issued by the IC-MJE 14 . Novel ICMJE recommendations always appear as provocative, and often as too ambitious, when initially presented.…”

“…Međutim, transparentnost je također jedno od vodećih načela znanstvenoga procesa 5-8 . Ovaj će pregledni rad raspravljati o novim uredničkim preporukama o razmjeni podataka, koje je izdao ICMJE 14 . Kada ih se prvi put iznese, nove preporuke ICMJE-a uvijek izgledaju provokativno te često pretjerano ambiciozno.…”