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An ethnographic study of collaborative clinical trial protocol writing
John H Gennari1, Chunhua Weng, David W McDonald
1Biomedical and Health Informatics, University of Washington, Seattle, USA.
Studies in Health Technology and Informatics
|September 14, 2004
Summary
This study examined clinical trial protocol writing, revealing challenges in team collaboration. Findings offer insights for developing better tools to streamline the complex clinical research protocol development process.
Area of Science:
- Clinical Research
- Health Informatics
- Scientific Writing
Background:
- Clinical trial protocols are crucial for research integrity.
- Protocol writing is a complex, under-researched collaborative process.
- Existing research lacks analysis of protocol writer collaboration needs.
Purpose of the Study:
- To investigate the collaborative nature of clinical trial protocol writing.
- To identify common problems faced by protocol writing teams.
- To determine information and communication support needs for protocol writers.
Main Methods:
- Conducted an ethnographic study of a National Cancer Institute (NCI)-funded cooperative clinical trial group.
- Analyzed the team-based protocol writing process.
- Identified challenges and support requirements.
Main Results:
- The study revealed significant collaboration challenges in protocol development.
- Common problems and specific information/communication needs were identified.
- Recommendations were formulated to improve the writing process.
Conclusions:
- Understanding collaborative dynamics is key to improving protocol writing.
- The findings have implications for designing effective collaborative tools for clinical trial protocols.
- Streamlining protocol development can accelerate clinical research.