Investigating the Secondary Use of Clinical Research Data: Protocol for a Mixed Methods Study.

Background: The increasing emphasis to share patient data from clinical research has resulted in substantial investments in data repositories and infrastructure. However, it is unclear how shared data are used and whether anticipated benefits are being realized.

Objective: The purpose of our study is to examine the current utilization of shared clinical research data sets and assess the effects on both scientific research and public health outcomes. Additionally, the study seeks to identify the factors that hinder or facilitate the ethical and efficient use of existing data based on the perspectives of data users.

Methods: The study will utilize a mixed methods design, incorporating a cross-sectional survey and in-depth interviews. The survey will involve at least 400 clinical researchers, while the in-depth interviews will include 20 to 40 participants who have utilized data from repositories or institutional data access committees. The survey will target a global sample, while the in-depth interviews will focus on individuals who have used data collected from low- and middle-income countries. Quantitative data will be summarized by using descriptive statistics, while multivariable analyses will be used to assess the relationships between variables. Qualitative data will be analyzed through thematic analysis, and the findings will be reported in accordance with the COREQ (Consolidated Criteria for Reporting Qualitative Research) guidelines. The study received ethical approval from the Oxford Tropical Research Ethics Committee in 2020 (reference number: 568-20).

Results: The results of the analysis, including both quantitative data and qualitative data, will be available in 2023.

Conclusions: The outcomes of our study will offer crucial understanding into the current status of data reuse in clinical research, serving as a basis for guiding future endeavors to enhance the utilization of shared data for the betterment of public health outcomes and for scientific progress.

Trial Registration: Thai Clinical Trials Registry TCTR20210301006; https://tinyurl.com/2p9atzhr.

International Registered Report Identifier (irrid): DERR1-10.2196/44875.