Review article

https://doi.org/10.11613/BM.2016.035

IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity

Karmela Krleža-Jerić ; Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia
Mirko Gabelica ; Clinical Department of ENT, Head and Neck Surgery, Split University Hospital Center, Split, Croatia
Rita Banzi ; IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
Marina Krnić-Martinić ; Clinical Department of ENT, Head and Neck Surgery, Split University Hospital Center, Split, Croatia
Bibiana Pulido ; Centre de recherche interuniversitaire sur la mondialisation et le travail (CRIMT), Université de Montréal, Montreal, Canada
Mersiha Mahmić-Kaknjo ; Department of Clinical Pharmacology, Zenica Cantonal Hospital, Zenica, Bosnia and Herzegovina
Ludovic Reveiz ; Knowledge Management, Bioethics and Research Office, Pan American Health Organization, Washington DC, United States of America
Josip Šimić ; Central Medical Library, University of Split School of Medicine, Split, Croatia
Ana Utrobičić ; Central Medical Library, University of Split School of Medicine, Split, Croatia
Irena Hrgović ; School of Pharmacy, University of Split, Split, Croatia

Abstract

Introduction: The opening of research data is emerging thanks to the increasing possibilities of digital technology. The opening of clinical trial (CT) data is a part of this process, expected to have positive scientific, ethical, health, and economic impacts thus contributing to research integrity. The January 2016 proposal by the International Council of Medical Journal Editors triggered ample discussion about CT data sharing and reconfirmed the need for an ongoing assessment of its dynamics. The IMProving Access to Clinical Trials data (IMPACT) Observatory aims to play such a role, and assess the data sharing culture, policies, and practices of key players, the impact of their interventions on CTs, and contribute to a transformation of research. The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings.
Materials and methods: Methods include a scoping study of research, surveys, interviews, and an environmental scan of research data repositories.
Results: Our preliminary findings indicate that although opening of CT data has not yet been achieved, its evolution is encouraging. Initiatives by key players contribute to increasing of CT data sharing, and many barriers are shrinking or disappearing.
Conclusions: The major barrier is the lack of data sharing standards, from preparing data for public sharing to its curatorship, findability and access. However, experiences accumulated by sharing CT data according to “upon request” or “open” mechanisms could inform the development of such standards. The Vivli, CORBEL-ECRIN and Open Trials projects are currently working in this direction.

Keywords

clinical trial data sharing; research integrity; IMPACT Observatory

Hrčak ID:

167705

URI

https://hrcak.srce.hr/167705

Publication date:

15.10.2016.

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