PHPS40970 Clinical Trials

Academic Year 2021/2022

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.

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Curricular information is subject to change

Learning Outcomes:

On completion of this module students will be able to:
• Explain the advantages of well-designed interventional trials
• Propose optimal trial design for a range of research questions and scenarios
• Show awareness of the range of difficulties and limitations which interventional trials encounter
• Show an appreciation for the role of competent authority regulation and good clinical practice in trial conduct
• Devise and implement a best-practice Statistical Analysis Plan for simple clinical trials

Student Effort Hours: 
Student Effort Type Hours
Specified Learning Activities

20

Autonomous Student Learning

70

Lectures

24

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 Open Book Exam Component Scale Must Pass Component % of Final Grade
Group Project: Capstone group project on clinical trial design Throughout the Trimester n/a Standard conversion grade scale 40% No

40

Examination: End of trimester exam - short and long questions 2 hour End of Trimester Exam No Standard conversion grade scale 40% No

60


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
• Peer review activities

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.

Timetabling information is displayed only for guidance purposes, relates to the current Academic Year only and is subject to change.
 

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