Taken from ICH Topic E 9 Statistical Principles for Clinical Trials "The role of statistics in clinical trial design and analysis is acknowledged as essential…”
“…it is assumed that the actual responsibility for all statistical work associated with clinical trials will lie with an appropriately qualified and experienced statistician…”
The CRCTU have a dedicated and experienced Biostatistics Team who play a fundamental role in the design and analysis of clinical trials in addition to contributing to methodological and clinical research at a national and international level.
Cindy Billingham & Keith Wheatley
The team consists of a large number of Biostatisticians specialising in specific disease, phase and methodological areas in adult and paediatric research.
Role of the Team
- Trial design
- Development of novel trial methodology
- Data analysis
- Report preparation
- Presentation of results at (inter)national meetings
- Publication of results in high impact journals
The team have experience in:
- Randomised controlled and single arm trials
- Early phase trials
- Analysis of survival data
- Biomarker trial design
- Prognostic and predictive modelling
- Analysis of trials with translational endpoints
- Analysis of quality of life data
- Meta-analysis and systematic reviews
Members of the team contribute to Clinical Study Groups, Data Monitoring Committees, and editorial boards. Committee membership also includes statistical societies (Royal Statistical Society and International Society for Clinical Biostatistics) and international disease site specific groups.