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• W4380608811 abstract "Trial registration, results disclosure, and sharing of analyzable individual participant data (IPD) 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 has been largely the case until now. Fully transparent clinical research diminishes publication bias, increases accountability, avoids unnecessary duplication of research (and thus avoid research waste), efficiently advances research, provides more reliable evidence for diagnostic and therapeutic interventions, regains public trust, and contributes to research integrity. Transparency of clinical trials, at a minimum, means sharing information about the trial design, conduct, and results, as well as the analyzable data. Not only must the information itself be explicitly documented, but an access location or medium for distribution also must be provided. Thus, transparency is realized by making research protocols, results, and cleaned and anonymized IPDs publicly available using well-defined, freely accessible electronic tools. Many electronic tools enabling sharing clinical trial information have emerged. These tools include registries hosting protocol data, results databases hosting aggregate data, and research data repositories hosting reusable and analyzable data sets and other research-related information. These tools are at different levels of development and are plagued with heterogeneity as international standards for trial registration do not yet address the sharing of individual patient data. Additionally, the need to measure and improve clinical trial transparency has led to development of specific electronic tools. This chapter is relevant for any professional involved in clinical trials and the use of the knowledge generated from them, including clinical and biomedical researchers, clinical trialists, systematic reviewers, information technology and informatics specialists, patients, journal editors, and public and private research funders and sponsors. Suggested competencies and learning activities for specific roles are presented at the end of the chapter." @default.
• W4380608811 created "2023-06-15" @default.
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• W4380608811 date "2023-01-01" @default.
• W4380608811 modified "2023-10-03" @default.
• W4380608811 title "Clinical Trial Registries, Results Databases, and Research Data Repositories" @default.
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• W4380608811 doi "https://doi.org/10.1007/978-3-031-27173-1_17" @default.
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