Data management in diabetes clinical trials: a qualitative study

Abstract

Abstract Background Clinical trials play an important role in expanding the knowledge of diabetes prevention, diagnosis, and treatment, and data management is one of the main issues in clinical trials. Lack of appropriate planning for data management in clinical trials may negatively influence achieving the desired results. The aim of this study was to explore data management processes in diabetes clinical trials in three research institutes in Iran. Method This was a qualitative study conducted in 2019. In this study, data were collected through in-depth semi-structured interviews with 16 researchers in three endocrinology and metabolism research institutes. To analyze data, the method of thematic analysis was used. Results The five themes that emerged from data analysis included (1) clinical trial data collection, (2) technologies used in data management, (3) data security and confidentiality management, (4) data quality management, and (5) data management standards. In general, the findings indicated that no clear and standard process was used for data management in diabetes clinical trials, and each research center executed its own methods and processes. Conclusion According to the results, the common methods of data management in diabetes clinical trials included a set of paper-based processes. It seems that using information technology can help facilitate data management processes in a variety of clinical trials, including diabetes clinical trials.

Keywords

• Clinical trial
• Diabetes
• Data management
• Clinical data management
• Medical informatics