EPI 205: Clinical Trials (Winter 2014)
Section outline
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Clinical Trials
EPI 205 Fall 2014 (1.5 units)
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Course Director: Dennis Black, MA, PhD
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Professor, Department of Epidemiology & Biostatistics
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Lecture: Design, Subjects and Randomization
Definition and importance of randomized controlled trials (RCT); examples of RCTs; disadvantages; alternatives; reasons for doing RCTs; randomization; inclusion/exclusion criteria; study designs including classical RCT, factorial designs, cross-over designs, matched pairs, cluster or grouped randomization.
Faculty: Dennis Black
Location: China Basin 6702 -
Lecture: Blinding, Intervention and Controls
Definition and importance of blinding; strategies if the study can’t be blinded; strategies to evaluate blinding; considerations when choosing the intervention; multiple interventions; importance of the control or placebo; advantages and disadvantages of equivalence trials.
Faculty: Deborah Grady
Location: China Basin 6702
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Small Group Discussion Section
Faculty: Mary Beattie, Yoshimi Fukuoka, Trisha Hue, Anne Schafer, John Shepherd, Jeff Tice
Location: Beattie CB 5740, Fukuoka CB 5759, Hue CB 6601, Schafer CB 5721, Shepherd CB 6702, Tice CB 5759 (2:00 - 3:30 pm)
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Lecture: Statistical Issues in Randomized Trials
Pervasiveness of multiple comparisons in randomized trials; the general problem of multiple comparisons and statistical adjustments; multiple endpoints; statistical concerns about subgroup analyses; what to do with an unexpected subgroup finding; adverse experience categorization; multivariate adjustment.
Faculty: Dennis Black
Location: China Basin 6702
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Lecture: Measuring Outcomes and Adverse Effects
Defining adverse events; elicited vs. volunteered; nuisance adverse events; pitfalls of attribution of cause; FDA adverse events classifications.
Faculty: Steve Cummings
Location: China Basin 6702
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Small Group Discussion Section
Faculty: Mary Beattie, Yoshimi Fukuoka, Trisha Hue, Anne Schafer, John Shepherd, Jeff Tice
Location: Beattie CB 5740 Fukuoka CB 5759, Hue CB 6601, Schafer CB 5721, Shepherd CB 6702, Tice CB 5759 (2:00 - 3:30 pm)
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Lecture: Follow-up, Adherence to the Protocol, and Post-Randomization and Introduction to Sample Size Planning
Follow-up in RCTs; what happens after randomization; patient compliance or adherence; effect of incomplete follow-up; strategies to enhance compliance; intention-to- treat and per-protocol analyses; analysis based on post-randomization; subgroup analysis.
Faculty: Dennis Black
Location: China Basin 6702 -
Lecture: Ethics in Clinical Trials and Interim Monitoring
Ethical issues in clinical trials, including choice of interventions in control and intervention groups, randomization, selection of subjects, and interim analysesWhy alter/stop a clinical trial early; who should decide to stop the trial; what parameters should be monitored and how often; what statistical methods should be used; statistical approaches
Faculty: Deborah Grady
Location: China Basin 6702 -
Small Group Discussion Section
Faculty: Mary Beattie, Yoshimi Fukuoka, Trisha Hue, Anne Schafer, John Shepherd, Jeff Tice
Location: Beattie CB 5740, Fukuoka CB 5759, Hue CB 6601, Schafer CB 5721, Shepherd CB 6702, Tice CB 5759 (2:00 - 3:30 pm)
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Lecture: Nuts and Bolts - Conducting a Trial
Should one do a trial; pilot studies; funding sources; contracts; budgets; the study team; team management; space; recruitment of study subjects; starting the protocol; forms; compliance and follow-up; final visit and post-trial.
Faculty: Deborah Grady
Location: China Basin 6702 -
Lecture: Multicenter Studies and Industry-sponsored trials
The anatomy and physiology of multicenter trials. How to work effectively and make use of data from such trials. How industry trials operate. Pros and cons of participation in industry sponsored trials and principles that may minimize bias.Faculty: Steve Cummings
Location: China Basin 6702