MAS3329/8329 Course outline

Below is an outline of the topics covered in the course, together with references to the course text. The references are generally the same in both editions: where they differ the principal reference is to the second edition, with the reference to the first edition in []. Clicking on the links in each topic will provide a brief summary of each of the items in that topic.

No.	Topic	Contents	References to course text
1	Introduction to Clinical Trials	i) Definition of a trial ii) Historical background iii) Empirical approach and importance of statistics iv) Ethical issues	i) 1.1. ii) 1.2.1 iii) 1.2.2 iv) 1.2.3
2	Structure of a Trial	i) General structure ii) Eligible patients iii) Control groups iv) Allocation at random	i) 1.3 ii) 1.3.1 iii) 1.3.2 iv) 1.3.3
3	Bias	i) What is bias ii) Selection bias iii) Allocation bias iv) Assessment bias v) Publication bias and stopping rules	i) 2.1 ii) 2.2.1 iii) 2.2.2 iv) 2.2.3 v) 2.2.4 & 2.2.5
4	Sample size estimation	i) Why do it? ii) Role of hypothesis tests iii) Normal variables iv) Binary variables	i) 3.1 ii) 3.2 iii) 3.3 iv) 3.4
5	Allocation	i) Simple randomization ii) Random permuted blocks iii) Unequal randomization iv) Stratification v) Minimization	i) 4.1 ii) 4.2 iii) 4.4 [4.3] iv) 4.5 [4.4] v) 4.6 [4.5]
6	Assessment	i) Double and single blindness ii) Placebos	i) 5.1 ii) 5.2
7	Analysis	i) Use of confidence intervals ii) Uses and abuse of baselines iii) Analysis of covariance	i) 6.2 ii) 6.3 iii) 6.4
8	Crossover trials	i) The crossover design ii) The model including period effect iii) Carryover effect	i) 11.1 [10.1/10.2] ii) 11.3 [10.3] iii) 11.4 [10.4]
9	Subgroups and multiple outcomes	i) Subgroup analyses ii) Methods for comparing and selecting subgroups iii) Multiple outcomes and correction of P-values	i) 9.1 [8.1] ii) 9.2/9.3 [8.2/8.3] iii) 9.5/9.6 [8.5/8.6]
10	Protocols and protocol deviations	i) The trial protocol ii) Protocol deviations iii) Intention to treat analysis	i) 10.1 [9.1] ii) 10.2 [9.2] iii) 10.3 [9.3]