This course focuses on the theoretical underpinnings of clinical research and the practical aspects of conducting clinical trials: the rationale for design features of Phase I, II, and III trials, recruitment of participants, techniques for randomization, data collection and endpoints, interim monitoring, and results reporting. Experts will deliver lectures on such topics as pitfalls in design and interpretation, missing data, nonpharmacological trials, and clinical trials involving medical devices. Students will prepare a full proposal for an original clinical trial, using the NIH Research Project (R01) grant format, and will critique proposals of fellow students in a mock study section setting.

This class is credit/no credit. For it to count towards the certificate, you must earn credit.

Topics Include

  • Introduction to clinical trials
  • Overview of phase I and II trials
  • Interventions, participants, and outcomes
  • Basic trial designs
  • Sample size and power
  • Early phase trials
  • Adaptive trials
  • Handling missing data
  • Recruitment, retention, and adherence
  • Data analysis overview
  • Interim monitoring, statistical issues
  • Interim monitoring, data monitoring committees
  • Pragmatic trials; multicenter trials
  • Comparative effectiveness trials; point-of-care trials
  • Pitfalls in design and interpretation
  • Clinical trials involving medical devices
  • Mock study section overview and sessions