Spring 2027

Clinical Trial Design, Implementation, and Analysis

Covers fundamental elements of clinical trials, statistical design considerations like randomization, and designs for Phase I-III studies including adaptive and master protocols.

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Summary

What you’ll be able to do

  • Summarize the objectives of clinical trials and key statistical design components

  • Design the clinical trials and investigate the operating characteristics of the design to implement clinical trials

  • Write the protocol section of statistical considerations and communicate the design of clinical trials to both statisticians and clinicians

  • Build sequential and adaptive methods for clinical trials

Source: UW Guide 1 UW Guide 2

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Prerequisites

Course map

STAT 609, 610,B M I/​STAT 641, or graduate/professional standing

BMI/STAT 643

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Professors

Spring 2027

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Calendar & sections

Spring 2027

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Student experience

the class

Gain an understanding of fundamental elements of clinical trials (such as objectives, endpoints, surrogate endpoints, and statistical decisions) and statistical design considerations (such as randomization and blinding). Designs of clinical trials for Phase I, II, and III studies including single-arm, two-arm, and drug combination trials. Introduction to adaptive designs for precision medicine and master protocol designs such as umbrella trials and basket trials.

difficulty & workload

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Topics

  • Fundamental elements of clinical trials
  • Statistical design considerations
  • Adaptive and master protocol designs

Skills

  • Designing clinical trials and investigating operating characteristics
  • Writing protocol sections for statistical considerations
  • Building sequential and adaptive methods

Grades

Instructor

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Sources & history

UW–Madison

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Dataset & model

Recorded 2026-10-14

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Model outputs & technical records
Qwen/Qwen3.8-27B
LLM outputs across runs
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Full model traces

Recorded model configuration, reasoning, and tool conversations.

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Model & dataset provenance 
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  "model": "Qwen/Qwen3.8-27B",
  "model_revision": "1d4bf0f2ff6012fd82039f2fa52739d0dd7c60c0",
  "task_version": "17",
  "output_id": "44c59a2edd51be8b7164a24d39c89f386df1d89651dc068ddee2db8f0d3cc8bb",
  "requirements_status": "valid",
  "dataset_revision": "fc1811fa52e581ea57a35c0cf3343f8740a8ffbf",
  "observed_at": "2026-10-14 17:50:09.728220+00:00"
}