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  2. CI 726A

Advanced Clinical Trials, A
CI 726A

Course Information

Description

This course delves into greater detail on advanced study designs and statistical issues in clinical trials. The format will be interactive with student led journal club. The course objectives include the following:

  1. Summarize principles of clinical trial design including bias control, random error control, randomization, blocking, and masking;
  2. Describe the role of Phase I and Phase II trials in drug development;
  3. Compare and contrast traditional and non-traditional clinical trial design, including various adaptive trial designs;
  4. Understand Bayesian and frequentist considerations in trial design;
  5. Compare and contrast non-inferiority, cluster, cross-over, factorial, and pragmatic trials; and
  6. Describe the role of biomarkers and surrogate outcomes in trial design.

School Harvard Medical School
Credits 2
Cross Reg

Not Available for Cross Registration

Course Component Lecture/Workshop
Instruction Mode In Person
Grading Basis HMS Satisfactory/Unsatisfactory
Course Requirements CI-726: 702 & 710 required
Curriculum Phase N/A
Visiting Clerks N/A
Course Type N/A