Izvorni znanstveni članak

https://doi.org/10.11613/BM.2018.010201

Setting the IMPACT (IMProve Access to Clinical Trial data) Observatory baseline

Mersiha Mahmić-Kaknjo ; Department of Clinical Pharmacology, Zenica Cantonal Hospital, Zenica, Bosnia and Herzegovina; Faculty of Medicine, University of Zenica, Zenica, Bosnia and Herzegovina
Josip Šimić ; Health Sciences Library, Faculty of Health Studies, University of Mostar, Mostar, Bosnia and Herzegovina
Karmela Krleža-Jerić ; IMPACT Observatory, Montreal, Canada 5Mediterranean Institute for Life Sciences - MedILS, Split, Croatia 6Croatian Cochrane Centre, Split, Croatia

Sažetak

Introduction: The aim of the IMPACT (IMProving Access to Clinical Trial data) Observatory is to assess the transformation of clinical trials (CT) related to the evolution of sharing of CT data. The objective of this study is to establish a baseline for monitoring CT data sharing by the Observatory.
Materials and methods: In this scoping review we searched for publications that address sharing, dissemination, transparency or reuse of CT data published prior to December 31st 2000. Two authors screened titles and abstracts of 1204 records received by Medline searches and added 47 publications from direct discovery. Four researchers extracted, coded, and analyzed the predefined information from 102 selected papers.
Results: We found a growing recognition of the importance of data sharing prior to 2001. However, there were numerous obstacles including the ambiguity of the concept of data sharing, the absence of specific terminology and the lack of an “open” culture. By the end of 2000, data, metadata, and evidence based medicine were defined. Data sharing, registries, databases and re-analyses of individual patient data (IPD) emerged. The use of systematic reviews and IPD meta-analysis in decision making was promoted. Most arguments for broader data sharing came from oncology, paediatrics, rare diseases, AIDS, pregnancy, perinatal medicine, and media reporting related scandals.
Conclusions: Our findings indicate that the year 2000 could be used as a baseline for monitoring the evolution of CT data sharing as basic prerequisites were set in place, including greater understanding that CT data sharing is essential for decision making and the advancements of the Internet.

Ključne riječi

clinical trial data sharing; baseline; databases; registries; Cochrane; scandals

Hrčak ID:

193633

URI

https://hrcak.srce.hr/193633

Datum izdavanja:

15.2.2018.

Posjeta: 1.055 *