Tentative Schedule of Topics Date Topics Reading Material and Assignments September 2 Course Objectives Tsiatis and Zheng Ch 1 Review of Epidemiology principles FCT chapters 1-2 History and Introduction to Clinical Trials September 9 Phase I Tsiatis and Zheng Ch 2 pharmacology, toxicity, safety, FCT Ch 1-2 Piantatosi Ch 4,12 MTD; early phase Phase II Clinical Trials common designs, Gehan, Simon September 16 Phase III Tsiatis and Ch 3 Rationale Piantatosi Ch 6 FCT Ch 1,5 Issues to consider before designing trial Ethical consideratons The RCT Common designs Review of conditional Expectation and variance September 23 Fixed Allocation Randomization Tsiatis and Chapter 4,5,6 Simple Randomization FCT Ch6,7,8 Permuted block randomization Piantadosi Ch. 5, 7,9 Stratified Randomization Additional Issues in Phase III HW set 1 due. Blinding and Placebo Ethics Protocol document Sample size considerations Hypothesis testing Deriving sample size to achieve desired power Comparing two response rates Comparing More Than Two Treatments Tsiatis and Zheng Ch 7 September 30 Testing equality using FCT Ch 5,8 independent normally distributed estimators Testing equality of dichotomous response rates Multiple comparisons K-sample tests for continuous Equivalency Trials October 7 No Class (Fall Break) October 14 Survival analysis in Clinical trials FCT Ch 15 Describing the Distribution of Tsiatis and Zheng Ch 9 Time to Event Piantadosi Ch. 12 Censoring and Life-Table Mid-term exam distributed Methods (Due October 28) Kaplan-Meier or Product-Limit Estimator Note: you will get a homework set Two-sample Log-rank and your exam after this class. Power and Sample Size Based on the Log-rank Test K-Sample tests
Tentative Schedule of Topics Date Topics Reading Material and Assignments September 2 Course Objectives Review of Epidemiology principles History and Introduction to Clinical Trials Tsiatis and Zheng Ch 1 FCT chapters 1-2 September 9 Phase I pharmacology, toxicity, safety, MTD; early phase Phase II Clinical Trials common designs, Gehan, Simon Tsiatis and Zheng Ch 2 FCT Ch 1-2 Piantatosi Ch 4,12 September 16 Phase III Rationale Issues to consider before designing trial Ethical consideratons The RCT Common designs Review of conditional Expectation and variance Tsiatis and Ch 3 Piantatosi Ch 6 FCT Ch 1,5 September 23 Fixed Allocation Randomization Simple Randomization Permuted block randomization Stratified Randomization Additional Issues in Phase III Blinding and Placebo Ethics Protocol document Sample size considerations Hypothesis testing Deriving sample size to achieve desired power Comparing two response rates Tsiatis and Chapter 4,5,6 FCT Ch6,7,8 Piantadosi Ch. 5, 7,9 HW set 1 due. September 30 Comparing More Than Two Treatments Testing equality using independent normally distributed estimators Testing equality of dichotomous response rates Multiple comparisons K-sample tests for continuous Equivalency Trials Tsiatis and Zheng Ch 7 FCT Ch 5,8 October 7 No Class (Fall Break) October 14 Survival analysis in Clinical trials Describing the Distribution of Time to Event Censoring and Life-Table Methods Kaplan-Meier or Product-Limit Estimator Two-sample Log-rank Power and Sample Size Based on the Log-rank Test K-Sample tests FCT Ch 15 Tsiatis and Zheng Ch 9 Piantadosi Ch. 12 Mid-term exam distributed (Due October 28) Note: you will get a homework set and your exam after this class.
BST665.docx