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


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.
Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.
Karmela
K
Krleža-Jerić
Clinical Department of ENT, Head and Neck Surgery, Split University Hospital Center, Split, Croatia.
Mirko
M
Gabelica
IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Rita
R
Banzi
Clinical Department of ENT, Head and Neck Surgery, Split University Hospital Center, Split, Croatia.
Marina Krnić
MK
Martinić
Centre de recherche interuniversitaire sur la mondialisation et le travail (CRIMT), Université de Montréal, Montreal, Canada.
Bibiana
B
Pulido
Department of Clinical Pharmacology, Zenica Cantonal Hospital, Zenica, Bosnia and Herzegovina.
Mersiha
M
Mahmić-Kaknjo
Knowledge Management, Bioethics and Research Office, Pan American Health Organization, Washington DC, United States of America.
Ludovic
L
Reveiz
Health Sciences Library, Faculty of Health Studies, University of Mostar, Mostar, Bosnia and Hercegovina.
Josip
J
Šimić
Central Medical Library, University of Split School of Medicine, Split, Croatia.
Ana
A
Utrobičić
School of Pharmacy, University of Split, Split, Croatia.
Irena
I
Hrgović
D002986:Clinical Trials as Topic; D019317:Evidence-Based Medicine; D006801:Humans; D033181:Information Dissemination; D007255:Information Services
IMPACT Observatory; clinical trial data sharing; research integrity