Evidence map›Paper›PMID 27812300›Full record

ReviewBiochemia medica2016

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

Karmela Krleža-Jerić, Mirko Gabelica, Rita Banzi, Marina Krnić Martinić, Bibiana Pulido, Mersiha Mahmić-Kaknjo, Ludovic Reveiz, Josip Šimić, Ana Utrobičić, Irena Hrgović

Open access · diamondAbstract readReview
In one paragraph

Review in Biochemia medica, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 5 countries.

Karmela Krleža-JerićDepartment of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.
Mirko GabelicaClinical Department of ENT, Head and Neck Surgery, Split University Hospital Center, Split, Croatia.
Rita BanziIRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
Marina Krnić MartinićClinical Department of ENT, Head and Neck Surgery, Split University Hospital Center, Split, Croatia.
Bibiana PulidoCentre de recherche interuniversitaire sur la mondialisation et le travail (CRIMT), Université de Montréal, Montreal, Canada.
Mersiha Mahmić-KaknjoDepartment of Clinical Pharmacology, Zenica Cantonal Hospital, Zenica, Bosnia and Herzegovina.
Ludovic ReveizKnowledge Management, Bioethics and Research Office, Pan American Health Organization, Washington DC, United States of America.
Josip ŠimićHealth Sciences Library, Faculty of Health Studies, University of Mostar, Mostar, Bosnia and Hercegovina.
Ana UtrobičićCentral Medical Library, University of Split School of Medicine, Split, Croatia.
Irena HrgovićSchool of Pharmacy, University of Split, Split, Croatia.
University of Split · HRMario Negri Institute for Pharmacological Research · ITUniversité de Montréal · CAUniversity of Mostar · BAUniversity of Zenica · BAWorld Health Organization Regional Office for the Americas · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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

methodsMethods include a scoping study of research, surveys, interviews, and an environmental scan of research data repositories.

resultsOur 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.

conclusionsThe 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.

Indexed as

Clinical Trials as TopicInformation DisseminationInformation ServicesEvidence-Based MedicineHumansclinical trial data sharingIMPACT Observatoryresearch integrity

Identifiers

PMID27812300
PMCPMC5082220
OpenAlexW2530827738

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.