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OBJECTIVES

This course covers current issues in the design and analysis of randomized clinical trials (RCTs). It is part of the Biostatistical Methods in Clinical Research series, continuing on from Biostatistical Methods IV (Biostat 210), covering additional biostatistical methods and allowing more in-depth exploration of the topics of Biostatistical Methods II (Biostat 208) and III (Biostat 209).

In the health-care setting, randomized controlled trials (RCTs) are experiments in which investigators randomly assign eligible patients into intervention groups, and then compare the outcomes of the groups to determine the relative effect of the intervention. The primary outcome variable in such trials is typically a measure of ultimate clinical status, such as disease progression. In this course, we will examine study design and analysis methods that have been developed to ensure the validity of the results of RCTs.

PREREQUISITES

Designing Clinical Research (Epi 202), Biostatistical Methods I (Biostat 200) or Intro to Statistical Analysis (Biostat 183), Biostatistical Methods II (Biostat 208) and III (Biostat 209). Exceptions to these prerequisites may be made with the consent of the Course Director, space permitting.

FACULTY

FORMAT

Course Outline:
1. Course Director will present three methodological lectures. Specific topics include:

• Superiority and noninferiority study designs
• Group sequential monitoring of trials with continuous, binary, or time-to-event outcomes
• Adaptive monitoring of trials with rapidly observed outcomes relative to accrual time

2. Students will:

• select for review one or more publications that extend the material presented in the lectures
• present an oral review of the publication(s) to the class
• submit a written review of the publication(s)

Monday, Jan 18, 2010: Proposals for student projects (selection of paper/topic) must be submitted to the Course Director via e-mail by 5 P.M. Papers for review will be chosen with input from the Course Director from among (i) methodological publications, (ii) applied publications, and (iii) student projects that substantially address course topics.
Tuesdays, Jan 26, Feb 2, & Feb 9, 2010: Student oral presentations. The quality and length of oral reports should typify those made to professional societies (10 minutes). Each presentation will be followed by a 5-10 minute discussion period.
Friday, Feb 12, 2010: Students will submit a written review (2 pages minimum). Written reviews are due via e-mail by 5 P.M. The written report will be typical of an "extended abstract.

GRADING

Grading: 30% classroom participation; 30% oral presentation; 40% written reports.

ENROLLMENT

This course is open to a limited number of individuals outside of the ATCR and Master's programs. Preference is given to UCSF-affiliated personnel. We regret that auditing is not permitted. To apply for this course please fill out and submit the application below. Cost and submission information are in the application.

Application (Word doc, 20KB)