Clinical trial data reuse – overcoming complexities in trial design and data sharing

Trials

Toby Wilkinson¹  Siddharth Sinha¹  Niels Peek¹  Nophar Geifman¹ 

[1] Centre for Health Informatics, Division of Informatics, Imaging, and Data Sciences, Faculty of Biology, Medicine and Health, University of Manchester;

关键词: Data sharing;    Clinical trials;    Pooled analysis;   

DOI  :  10.1186/s13063-019-3627-6

来源: DOAJ

【 摘 要 】

Abstract There are many acknowledged benefits for the reuse of clinical trial data; from independent verification of published results to the evaluation of new hypotheses. However, the reuse of shared clinical trial data is not without obstacles. Here we present some of the issues and lessons learned from our own experiences in accessing and analyzing trial data; specifically, where we aim to combine and pool data from multiple different trials. In addition to issues around missing annotation and incomplete datasets, we identify trial-design complexity as a potential hurdle that may complicate downstream analyses. We address potential solutions and emphasize the need for benefits of transparent sharing and analysis of participant-level clinical trial data with appropriate risk mitigation, a matter important to efficient clinical research.

【 授权许可】

Unknown