Various decisions related to the design of the trial will flow from the intention and research question put forward by the researcher. This section will overview topics focused on the architecture of the trial, including but not limited to, randomization schemes (e.g., individual vs. cluster-level randomization; parallel vs. stepped-wedge cluster trials), choice of a comparator group(s) (e.g., new intervention vs. unconstrained care), and choice of outcome(s) (e.g., clinical, patient reported, composite, surrogate). Related statistical considerations can be found in the Statistics section.
Modules from this section, featured in previous weeks, will be posted here over time.
November 25, 2024: Trial designs and randomization schemes: Part 1
January 13, 2025: Trial designs and randomization schemes: Part 2
January 20, 2025: Trial designs and randomization schemes: Part 3
February 3, 2025: Endpoints and outcomes in pragmatic trials
March 31, 2025: Trial designs and randomization schemes: Part 4
May 26, 2025: Sample size and power calculations: an introduction
June 9, 2025: Biases in clinical trials: an introduction