We offer support and offer expertise on:
- Trial design, including appropriate sample size
- Protocol development and case report form design
- Research costs and funding applications
- Establishing collaborative networks of investigators
- Gaining research ethics and regulatory approval
- Randomisation procedures
- Strategies for patient recruitment
- Trial co-ordination and data management
- Research governance and quality assurance procedures
- Database design and computerised trial management software
- Incorporation of health economics and quality of life measures
- Independent data monitoring
- Statistical analysis and reporting
- Training courses, workshops and seminars
We advise on:
BCTU’s focus is large scale late phase randomised controlled trials (RCTs), and test evaluation studies.
We are unable to provide advice on cohort or case-controlled studies, surveys, physiological or epidemiological studies, unless they are related to an RCT, diagnostic or test evaluation study. We also have limited experience of early phase (I) clinical trials. Please contact your local Research Design Service, who will be able to signpost you to appropriate support.
The BCTU will not become involved in studies once recruitment has started, nor will the Unit undertake statistical analysis of studies where it has had no involvement in the design or management of the study.
The BCTU will only advise on and support studies that are to be funded by non-commercial sources or where industry support will be “without strings”. It is beyond the remit of the Unit to act as the statistical centre for commercially sponsored studies.