This unit of study will focus on the strengths and weaknesses of different clinical study designs. Designs considered will include cohort (retrospective and prospective), cross-sectional, case-control and randomized controlled designs. The different phases of clinical trial designs in the development of therapies will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Extension and adaptation of randomized designs will also be covered including cluster and factorial designs and adaptive pilot studies. Students will gain the skills necessary to choose between these designs for best practice. Types of outcomes (continuous, categorical, time-to-event) will be discussed. Methods of allocating participants to interventions (randomization), as well blinding and allocation concealment will be covered together with aspects of protocol development. On completion of this unit, the student will be familiar with the differences between study types and study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop stratified randomisation schemes for their own studies.
discussion groups and problem based learning
1 x short answer quiz (5%), 1 x peer review of an anonymised student's submission (5%),1 x online multiple choice quiz (5%), 1 x short answer (including calculations) quiz (5%), 2 x assignments with both short and long answer questions with calculations and diagrams (2 x 40%)
Recommended reading: many available eg S Piantadosi, Clinical Trials A Methodological Perspective. KJ Rothman and S Greenland Modern Epidemiology. Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.