These are the course materials from our modules (EH6124 and EH6126) on clinical trial design and analysis. For the official module descriptions, please see:
EH 6124 - Introduction to Clinical Trial Design and Analysis
EH 6126 - Advanced Clinical Trial Design and Analysis
These modules are offered as a part of our Postgraduate Programme in Clinical Trials (Certificate, Diploma, and MSc), and delivered by Darren Dahly (@statsepi) and Brendan Palmer (@b_a_palmer) of the HRB Clinical Research Facility Cork - Statistics and Data Analysis Unit.
We are posting these materials online for two reasons. The first is that we think properly designed and analysed randomized controlled trials are critical for evaluating the impact of clinical interventions, and so we hope these open materials are useful for anyone wanting to run effective clinical trials. The second is that we acknowledge that we don't (and can't) know everything there is to know about clinical trials, and so hope that the wider community of experienced medical statisticians and trialists might contribute their suggestions on how we might improve our modules.
Each of the two modules consists of eight units. The introductory module focuses on relatively simple two-arm parallel superiority trials with fixed designs, and frequentist statistical inference. The second, advanced module then introduces deviations from this, such as non-inferiority trials, cluster and cross-over designs, adaptive trials, and Bayesian statistical inference.
Generally the units include some required reading (papers, book chapters, blog-posts), usually some additional reading, and one or more video lectures covering the key points for that unit. To help learners understand key concepts, we also use R/RStudio to run simulations and analyse trial data, and provide data analysis exercises for the learners to do on their own. This is the material that will make up the bulk of the material on this course page.