Data management in diabetes clinical trials: a qualitative study
Aynaz Nourani1, Haleh Ayatollahi2,3, Masoud Solaymani Dodaran4
1Department of Health Information Technology, Urmia University of Medical Sciences, Urmia, Iran.
Trials
|March 4, 2022
Summary
Diabetes clinical trials often lack standardized data management, relying on varied, paper-based methods. Implementing information technology could significantly improve data handling and trial outcomes.
Area of Science:
- Clinical Research
- Diabetes Mellitus
- Health Informatics
Background:
- Effective data management is crucial for successful clinical trials in diabetes prevention, diagnosis, and treatment.
- Inadequate data management planning can compromise the integrity and outcomes of clinical research.
- This study addresses data management practices within Iranian diabetes clinical trials.
Purpose of the Study:
- To explore and understand the current data management processes in diabetes clinical trials.
- To identify challenges and variations in data handling across different research institutions.
- To provide insights for improving data management in diabetes research.
Main Methods:
- A qualitative research approach was employed in 2019.
- Data collection involved in-depth, semi-structured interviews with 16 researchers.
- Thematic analysis was utilized to analyze the collected interview data.
Main Results:
- Five key themes emerged: data collection, technologies used, security/confidentiality, quality management, and standards.
- No uniform or standard data management process was identified across the studied diabetes clinical trials.
- Each research center utilized distinct, individualized methods and processes for data management.
Conclusions:
- Current data management in diabetes clinical trials predominantly relies on paper-based systems.
- The adoption of information technology presents a significant opportunity to streamline and enhance data management.
- Integrating technology can facilitate more efficient and robust data handling in various clinical trials, including those for diabetes.
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