DESIGN, CONDUCT AND ANALYSIS OF CLINICAL TRIALS
2015/2016, Semester 2
Saw Swee Hock School of Public Health (Saw Swee Hock School of Public Health)
Modular Credits: 4
This module will be conducted from 18 to 23 Jan 2016, 9am to 6pm.
For more information on topics and venues, please check the module schedule under
. Any changes to the schedule will be reflected in the module schedule.
Brief Module Description
In this module, issues in clinical trials, including blinding, randomisation, sample size, power, ethical, regulatory and quality-of-life issues will be addressed. Interim and sequential analyses, analysis of multiple treatments and endpoints, stratification and subgroup analyses, as well as meta-analysis of randomised controlled trials will also be discussed. Although particular emphasis is given to the evaluation of treatment in Phase III clinical trials, early phase trials studies will also be covered.
Upon completion of the module, the student will be able to:
Describe basic principles in the design, conduct and evaluation of clinical trials
Appreciate ethical and statistical issues involved in the conduct of clinical trials
Critically appraise and discuss published findings from clinical trials
Pre-requisite(s): CO5102 and CO5103
Class/Small Group Discussion
An overview of clinical trials, protocol development
Drug development and regulatory, good clinical practice
Early phase clinical trials
Phase III study design: Blinding and randomisation
Sample size and power estimation
Special considerations in trials of surgical therapy
Issues involving multiple treatment groups and endpoints
Stratification and subgroup analyses
Interim and sequential analysis
Quality of life evaluation in clinical trials
Meta-analysis of RCTs
Reporting and critical evaluation of clinical trials
When a student is unable to attend the required sessions, an excuse may be granted for limited time periods upon the production of evidence of illness, misadventure or leave of absence having been granted.
Students must inform the MPH Office if any of the above has taken place.
Failure to meet attendance requirements will affect module grading.