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 generalisabi

SUBMITTER: Lai J 

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

REPOSITORIES: biostudies-literature