临床研究数据二次利用的调查：一项混合方法研究的方案

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

作者信息

Waithira Naomi, Kestelyn Evelyne, Chotthanawathit Keitcheya, Osterrieder Anne, Mukaka Mavuto, Lang Trudie, Cheah Phaik Yeong

机构信息

Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.

Mahidol-Oxford Tropical Medicine Research Unit, Bangkok, Thailand.

出版信息

JMIR Res Protoc. 2023 Mar 6;12:e44875. doi: 10.2196/44875.

DOI:10.2196/44875

PMID:36877564

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10028503/

Abstract

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.

摘要

背景

日益强调共享临床研究中的患者数据，这促使人们对数据存储库和基础设施进行了大量投资。然而，尚不清楚共享数据是如何被使用的，以及预期的效益是否正在实现。

目的

我们研究的目的是考察共享临床研究数据集的当前利用情况，并评估其对科学研究和公共卫生成果的影响。此外，该研究旨在从数据使用者的角度确定阻碍或促进对现有数据进行道德和有效利用的因素。

方法

该研究将采用混合方法设计，包括横断面调查和深入访谈。调查将涉及至少400名临床研究人员，而深入访谈将包括20至40名使用过存储库数据或机构数据访问委员会数据的参与者。调查将针对全球样本，而深入访谈将聚焦于使用过从中低收入国家收集的数据的个人。定量数据将通过描述性统计进行汇总，而多变量分析将用于评估变量之间的关系。定性数据将通过主题分析进行分析，研究结果将按照COREQ（定性研究报告统一标准）指南进行报告。该研究于2020年获得牛津热带研究伦理委员会的伦理批准（参考编号：568 - 20）。