Seminar Series : Seminars Series II

Issues to Consider in the Design of Randomized Controlled Trials

Issues to Consider in the Design of Randomized Controlled Trials

This seminar will discuss the approach to the design of randomized controlled trials. Potential topics will include: observational vs. experimental studies, the rationale for randomization, simple vs. adaptive randomization, explanatory vs. intention to treat analysis, hypothesis classification (superiority vs. non-inferiority vs. equivalence trials), allocation concealment, blinding, the definitions and purposes of blocking, bias and confounding, attention controls, stopping rules, CONSORT, and the importance of statistical expertise in designing, monitoring, and interpreting the study.