Dataset Information

Existing barriers and recommendations of real-world data standardisation for clinical research in China: a qualitative study.

ABSTRACT:

Objective

To investigate the existing barriers and recommendations of real-world data (RWD) standardisation for clinical research through a qualitative study on different stakeholders.

Design

This qualitative study involved five types of stakeholders based on five interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.

Setting

Eight hospitals, four hospital system vendors, three big data companies, six medical products companies and four regulatory institutions were included.

Participants

In total, 62 participants from 25 institutions were interviewed through purposive sampling.

Results

The findings showed that the lack of clinical applicability in existing terminology standards, lack of generalisability in existing research databases, and lack of transparency in existing data standardisation process were the barriers of data standardisation of RWD for clinical research. Enhancing terminology standards by incorporating locally used clinical terminology, reducing burden in the usage of terminology standards, improving generalisability of RWD for research by using clinical data models, and improving traceability to source data for transparency might be feasible suggestions for solving the current problems.

Conclusions

Efficient and reliable data standardisation of RWD for clinical research can help generate better evidence used to support regulatory evaluation of medical products. This research suggested enhancing terminology standards by incorporating locally used clinical terminology, reducing burden in the usage of terminology standards, improving generalisability of RWD for research by using clinical data models, and improving traceability to source data for transparency to guide efforts in data standardisation in the future.

SUBMITTER: Lai J

PROVIDER: S-EPMC9353004 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

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Publications

Existing barriers and recommendations of real-world data standardisation for clinical research in China: a qualitative study.

Lai Junkai J Liao Xiwen X Yao Chen C Jin Feifei F Wang Bin B Li Chen C Zhang Jun J Liu Larry L

BMJ open 20220803 8

<h4>Objective</h4>To investigate the existing barriers and recommendations of real-world data (RWD) standardisation for clinical research through a qualitative study on different stakeholders.<h4>Design</h4>This qualitative study involved five types of stakeholders based on five interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.<h4>Setting</h4>Eight hospitals, four hospital system vendors, three big data companies, six medical products ...[more]

PMID: 35922113

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Project description:Different computational approaches are employed to efficiently identify novel repositioning possibilities utilizing different sources of information and algorithms. It is critical to propose high-valued candidate-repositioning possibilities before conducting lengthy in vivo validation studies that consume significant resources. Here we report a novel multi-methodological approach to identify opportunities for drug repositioning. We performed analyses of real-world data (RWD) acquired from the United States Food and Drug Administration's Adverse Event Reporting System (FAERS) and the claims database maintained by the Japan Medical Data Center (JMDC). These analyses were followed by cross-validation through bioinformatics analyses of gene expression data. Inverse associations revealed using disproportionality analysis (DPA) and sequence symmetry analysis (SSA) were used to detect potential drug-repositioning signals. To evaluate the validity of the approach, we conducted a feasibility study to identify marketed drugs with the potential for treating inflammatory bowel disease (IBD). Primary analyses of the FAERS and JMDC claims databases identified psycholeptics such as haloperidol, diazepam, and hydroxyzine as candidates that may improve the treatment of IBD. To further investigate the mechanistic relevance between hit compounds and disease pathology, we conducted bioinformatics analyses of the associations of the gene expression profiles of these compounds with disease. We identified common biological features among genes differentially expressed with or without compound treatment as well as disease-perturbation data available from open sources, which strengthened the mechanistic rationale of our initial findings. We further identified pathways such as cytokine signaling that are influenced by these drugs. These pathways are relevant to pathologies and can serve as alternative targets of therapy. Integrative analysis of RWD such as those available from adverse-event databases, claims databases, and transcriptome analyses represent an effective approach that adds value to efficiently identifying potential novel therapeutic opportunities.

Dataset Information

Existing barriers and recommendations of real-world data standardisation for clinical research in China: a qualitative study.

Objective

Design

Setting

Participants

Results

Conclusions

Publications

Existing barriers and recommendations of real-world data standardisation for clinical research in China: a qualitative study.

Similar Datasets

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