Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 8, 2022
Date Accepted: Feb 14, 2023
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Understanding the extent and impact of secondary use of clinical research data with a focus on Low and Middle Income Countries: a cross sectional mixed methods study (REUSE)
ABSTRACT
Background:
Significant investment has been made in establishment of data repositories and the underlying infrastructure in order to facilitate sharing of individual-level clinical research datasets. However, there is limited empirical evidence on how shared datasets are used, who uses the data and whether the expected gains of data sharing and reuse are being realised.
Objective:
We aim to bridge the evidence gap first, by documenting if and how clinical research datasets are accessed and reused; secondly, we will explore what impact data reuse has had on scientific research and general public health; and finally we will describe barriers and opportunities to promote data reuse from the perspective of secondary data users.
Methods:
This mixed method study will combine quantitative data from a cross-sectional survey and qualitative data from semi-structured in-depth interviews. The self-administered online survey will include at least 400 individuals who are either clinical researchers who collect primary data or secondary users of clinical research data. Semi-structured interviews will be conducted with 20-40 individuals who have requested and used clinical research data from data repositories or institutional Data Access Committees. Quantitative data will be analysed using descriptive statistics and relationships between variables will be explored using multi variable analyses. Qualitative data will be analysed using thematic content analysis. The findings will be reported following the Consolidated criteria for Reporting Qualitative research (COREQ) guidelines.
Results:
The project was started in 2021, the survey will close in December 2022 whilst in-depth interviews will be concluded in March 2022. The first results are expected to be submitted for publication in August 2022.
Conclusions:
Results from this work will be useful in identifying which interventions should be prioritized to increase equitable, ethical and efficient use of existing clinical research datasets. We anticipate that increased reuse of data will result in improved quality and transparency in science, improved public health and patient outcomes, and a better return on investment in research. Clinical Trial: TCTR20210301006
Citation
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