Explore UCD

UCD Home >

PHPS40970

Academic Year 2024/2025

Design and Analysis of Clinical Trials (PHPS40970)

Subject:
Public Health & Population Sci
College:
Health & Agricultural Sciences
School:
Public Hlth, Phys & Sports Sci
Level:
4 (Masters)
Credits:
5
Module Coordinator:
Professor Akke Vellinga
Trimester:
Spring
Mode of Delivery:
Blended
Internship Module:
No
How will I be graded?
Letter grades

Curricular information is subject to change.

This module will instruct the students on the principles of clinical research with particular emphasis on interventional trials. The advantages and difficulties of this research will be explained, with extensive examples. Aspects of trial design, with respect to randomisation, blinding, clustering, stratification, and longitudinal follow-up will be explored, and a group project will allow students to apply some of these principles.
Aspects relating to the statistical analysis of clinical trials will be explored, with particular reference to the International Conference on Harmonisation (ICH) guidelines (E9). Ethical, regulatory and governance aspects of clinical trials will be covered with particular reference to European (EMA) and United States (FDA) standards.
Assessment will be conducted through a group project, and an end of year exam.

About this Module

Learning Outcomes:

On completion of this module students will be able to:
• Explain the advantages of well-designed interventional trials
• Devise an optimal trial design for a given research question and scenario
• Acknowledge and propose solutions to the range of difficulties and limitations which interventional trials encounter
• Demonstrate understanding of the role of competent authority regulation and good clinical practice in trial conduct
• Devise and implement a best-practice Protocol for a simple clinical trial
• Carry out sample size estimation for selected RCTs
• Interpret results of RCTs terms of risks and benefits

Student Effort Hours:
Student Effort Type Hours
Lectures

24
Specified Learning Activities

20
Autonomous Student Learning

70
Total

114

Approaches to Teaching and Learning:
Lectures, online materials, assigned readings, formative quizzes and exercises.

Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Not applicable to this module.
 

Assessment Strategy
Description Timing Component Scale Must Pass Component % of Final Grade In Module Component Repeat Offered
Individual Project: A trial protocol will be developed with the students over the various weeks. They will have to submit a part for each topic to proceed to the next topic. This will form the final portfolio/protocol Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10 Graded Yes
60
 Yes
Individual Project: Visual presentation of the protocol Week 10 Graded No
10
 No
Exam (Online): online timed MCQ Week 12 Graded No
30
 No

Carry forward of passed components
No
 

Resit In Terminal Exam
Summer Yes - 2 Hour
Please see Student Jargon Buster for more information about remediation types and timing. 

Feedback Strategy/Strategies

• Feedback individually to students, on an activity or draft prior to summative assessment
• Online automated feedback

How will my Feedback be Delivered?

Staged presentations and review of drafts for the group project are conducted throughout the trimester, including lecturer and peer feedback, and self-reflection.

Name Role
Dr Ricardo Piper Segurado Lecturer / Co-Lecturer
Print this page
Fill in the following details:
Enter the body of your query here.

From time to time UCD would like to send you further information that we feel, based on your enquiry, would be of interest to you.