Designing and Running Streamlined Randomized Trials

 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