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

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.

journal_name

Biochem Med (Zagreb)

journal_title

Biochemia medica

authors

Krleža-Jerić K,Gabelica M,Banzi R,Martinić MK,Pulido B,Mahmić-Kaknjo M,Reveiz L,Šimić J,Utrobičić A,Hrgović I

doi

10.11613/BM.2016.035

subject

Has Abstract

pub_date

2016-10-15 00:00:00

pages

308-307

issue

3

eissn

1330-0962

issn

1846-7482

pii

bm-26-308

journal_volume

26

pub_type

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