Whether planning a large multicenter trial, or seeking to maximize the effectiveness of a smaller project, delegates on this course will learn how to design and run successful trials to produce reliable answers.
CTSU has extensive experience in conducting large clinical trials, which typically randomize thousands of participants, producing reliable results which change practice worldwide.
This intensive course will be delivered by a faculty of highly experienced clinical trialists, senior trial administrators and statisticians from CTSU.
This course is designed primarily for senior investigators from any discipline and experienced trial managers who want to conduct successful randomized trials.
The draft programme is available to view and download now.
Download the course flyer here.
Key topics covered:
- Choosing the research question: Identifying plausible treatment effects
- Trial design: Sample size, choice of outcomes, blinding, run-in, involving patients and the public
- Streamlined recruitment methods: Multi-site set up, pre-screening, consent and ethics, cost effective methods including mail-based studies
- Randomization methods: Pros and cons of stratification and minimization
- Efficient data collection: Electronic data capture, pre-coded outcomes, using routine data sources
- Adherence to study treatment: Impact of loss of adherence on study results, strategies to maintain adherence and obtain complete follow-up
- Effective monitoring: Efficient monitoring using statistical systems, effective mentoring of sites
- Event processing including regulatory requirements: Event processing and adjudication, pharmacovigilance and regulatory requirements
- The data monitoring committee, trial governance and the role of the steering committee
- Analysis and dissemination of results: Writing a data analysis plan, intention to treat analysis, how to handle missing data, appropriate interpretation of relative and absolute risks, avoiding misleading interpretation of subgroups, dissemination of results
- Workshops: Formulate an appropriate research question, estimate the required sample size and develop a trial protocol
Monday 11 April 2016 (half day) - lunch, evening meal and self study in Jesus College
Tuesday 12 April 2016 - lunch, dinner with faculty in Jesus College
Wednesday 13 April (half day) - lunch
(meals are included in the course fee)
Course £700 including ensuite accommodation with breakfast in Jesus College
£550 without accommodation
Book here now.