TICR Biostatistical Methods for Clinical Research V

Biostatistical Methods for Clinical Research V
Biostat 226 Winter 2008 (2 units)
Course Director: Joan Hilton, ScD, MPH
Associate Professor, Division of Biostatistics, Department of Epidemiology & Biostatistics

This course is part of the UCSF 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 from Biostatistical Methods II (Biostat 208) and III (Biostat 209). The course format is divided into two subject areas: 1) current issues in the design and analysis of randomized clinical trials (RCTs) and 2) statistical methods in bioinformatics.

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

Recently, high-throughput molecular technology - genomics and proteomics, for example - have revolutionized the way biology and diseases are studied, and begin to pave the way towards personalized medicine. RCTs that use molecular data as predictors, outcomes, or patient inclusion criteria also face special challenges in study design and data analysis. Statistical and bioinformatics methods are essential to reduce the sea of data to manageable components with biological interpretation. In this course, we will discuss methods for analyzing omics data using examples from published clinical research literatures.

The goals of this course are:
1. To understand the importance and pitfalls of bioinformatics in clinical research and the methods commonly used for the design and analysis of omics studies (Topic I: Bioinformatics; weeks 1-5).
2. To understand methods that ensure the validity of RCTs (Topic II: Current Issues in RCTs; weeks 6-11).

To achieve these goals:
1. Within each Course Topic, professors will present three methodological lectures.
2. Students will
o Within each Course Topic, select for written review one or more publications that extend the material presented in the lectures.
o Present one of the two reviews to the class.

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

Papers for review will be chosen with input from the instructors from among (i) methodological publications, (ii) applied publications, and (iii) student projects that substantially address course topics. Proposals for the student projects (selection of paper/topic) must be submitted to the instructor via e-mail by 5 P.M. as follows: Monday, Jan 21 for Bioinformatics presentations; Monday, Feb 25 for RCT presentations.

Students will submit two written reviews (each 2 pages minimum), one per Course Topic. Written reviews are due via e-mail by 5 P.M. as follows: Friday, Feb 8 for Bioinformatics reports; Friday, Mar 21 for RCT reports.

Students will present one oral review (10 minutes). Half the students will present an oral review of the first Course Topic and the other half will present that of the second Course Topic. The quality and length of oral reports should typify those made to professional societies. Each presentation will be followed by a 5-10 minute discussion period.

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.