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Clinical Trial Registries, Results Databases, and Research Data Repositories

  • Karmela Krleža-JerićEmail author
Chapter
Part of the Health Informatics book series (HI)

Abstract

Trial registration, results disclosure, and sharing of analyzable data are considered powerful tools for achieving higher levels of transparency and accountability for clinical trials. The emphasis on disseminating knowledge and growing demands for transparency in clinical research are contributing to a major paradigm shift in health research. In this new paradigm, knowledge will be generated from the culmination of all existing knowledge – not just from bits and parts of previous knowledge, as is largely the case now. The full transparency of clinical research is a powerful strategy to diminish publication bias, increase accountability, avoid unnecessary duplication of research (and thus avoid research waste), efficiently advance research, provide more reliable evidence for diagnostic and therapeutic interventions, and regain public trust. Transparency of clinical trials, at a minimum, means sharing information about the design, conduct, results, and analyzable data. Not only must the information itself be explicitly documented, but an access location or medium for distribution must be provided. In the case of clinical trials, the public disclosure of data is realized by posting cleaned and anonymized data in well-defined, freely accessible clinical trial registries and results databases. Making cleaned, anonymized individual participant data sets analyzable is still a challenge.

Basic electronic tools that enable sharing clinical trial information include registries hosting protocol data, results databases hosting aggregate data, and research data repositories hosting reusable/analyzable data sets and other research-related information. These tools are at different levels of development and plagued with heterogeneity as international standards exist only for trial registration. The lack of standards related to publishing data in repositories makes it difficult for researchers to decide where to publish and search for data from completed studies.

Keywords

Transparency in clinical research Trial registries International standards Results databases Protocol-Results-Data Cleaned Anonymized individual participant data (IPD) Analyzable data Research data repositories Reuse of data-Open data User perspectives 

Notes

Acknowledgments

The author would like to thank Nevena Jeric at Apropo Media for graphic design.

Disclaimer

The views expressed here are the author’s and do not represent the views of the MedILS or any other organization.

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Copyright information

© Springer International Publishing 2019

Authors and Affiliations

  1. 1.IMPACT Observatory, Mediterranean Institute for Life Sciences- MedILS, Split & Cochrane Croatia, University of Split School of MedicineSplitCroatia
  2. 2.Electronic Health Information Laboratory -EHIL, CHEOOttawaCanada

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