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CO5220 

DESIGN, CONDUCT AND ANALYSIS OF CLINICAL TRIALS
   2016/2017, Semester 2
   Saw Swee Hock School of Public Health (Saw Swee Hock School of Public Health)
Modular Credits: 4
  Tags: --

Schedule

TopThis 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 IVLE Files. Any changes to the schedule will be reflected in the module schedule.

Brief Module Description

TopIn 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.

Learning Outcomes

TopUpon completion of the module, the student will be able to:
  1. Describe basic principles in the design, conduct and evaluation of clinical trials
  2. Appreciate ethical and statistical issues involved in the conduct of clinical trials
  3. Critically appraise and discuss published findings from clinical trials      

Prerequisites

TopPre-requisite(s): CO5102 and CO5103

Preclusion(s): Nil

Teaching Modes

Top
  • Lecture
  • Workshops
  • Readings
  • Assignments
  • Class/Small Group Discussion
 

Syllabus

Top
  1. An overview of clinical trials, protocol development
  2. Drug development and regulatory, good clinical practice
  3. Early phase clinical trials
  4. Phase III study design: Blinding and randomisation
  5. Sample size and power estimation
  6. Special considerations in trials of surgical therapy
  7. Issues involving multiple treatment groups and endpoints
  8. Stratification and subgroup analyses
  9. Interim and sequential analysis
  10. Quality of life evaluation in clinical trials
  11. Meta-analysis of RCTs
  12. Reporting and critical evaluation of clinical trials

Assessment

Top
Class participation        10%
Quiz 20%
Written assignment* 20%
Final exam 50%
   
Total 100%


*Written assignment is due on 3 Feb 2017
 

Disclamier

TopWhen 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.

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