POPLHLTH 712 : Clinical Trial Design, Analysis and Management

Medical and Health Sciences

2022 Semester Two (1225) (15 POINTS)

Course Prescription

An exploration of methodological and practical aspects of clinical trial design, analysis and management. Participants will develop skills in designing and conducting randomised controlled trials.

Course Overview

Clinical trials are widely acknowledged as the most reliable means of determining causal relationships. Thus the role of trials is in evaluating the efficacy and effectiveness of interventions in healthcare. Clinical trials are not the “gold standard” design for all research questions. However, properly designed and well-managed clinical trials that are appropriately analysed will deliver accurate evidence about whether a treatment works and/or is safe.  

Clinical trials come in various forms and phases. POPLHLTH 712 focuses on the design of Phase 3 trials, and will cover the following trial designs:   two-arm and multi-arm trials; cluster and stepped-wedge trials; factorial, cross-over and n-1 trial trials; equivalence and non-inferiority trials; and zelen design trials.

This course aims to: 1) introduce students to the necessary skills to design the correct type of trial to answer a specific research question; 2) understand the key concepts of managing a trial’s conduct; and 3) understand the key statistical analyses used in trials and how to interpret them.  An understanding of basic statistics is beneficial.

Course Requirements

Prerequisite: POPLHLTH 708 or 709 or equivalent experience

Course Contacts

Course Co-ordinator: 
Dr Natalie Walker
Associate Professor in Population Health
Email: n.walker@auckland.ac.nz
Phone: +64 (0) 923 9884

Course administrator:
Mrs Upendra Wickramarachchi
Email: u.wicks@auckland.ac.nz

Capabilities Developed in this Course

Capability 1: Disciplinary Knowledge and Practice
Capability 2: Critical Thinking
Capability 3: Solution Seeking
Capability 4: Communication and Engagement
Capability 5: Independence and Integrity
Capability 6: Social and Environmental Responsibilities
Graduate Profile: Master of Public Health

Learning Outcomes

By the end of this course, students will be able to:
  1. Develop a study protocol for a randomised controlled trial (Capability 1.1, 1.2, 1.3, 2.1, 3.1, 4.1, 4.2, 5.2 and 6.1)
  2. Create a research question that includes key patient and health-care setting specific components (Capability 1.3, 3.1 and 4.1)
  3. Identify suitable study designs (and design elements) that maximise the internal and external validity of the research (Capability 1.2, 1.3, 2.1, 3.1, 3.2, 4.1, 4.2, 5.1, 5.2 and 6.1)
  4. Understand how to undertake a sample size calculation for a clinical trial, and chose the appropriate statistical tests for analyzing clinical trial data. (Capability 1.3, 2.1, 3.1, 4.1 and 5.2)
  5. Demonstrate an understanding of the key concepts of good clinical practice, including key documentation and filing requirements, trial monitoring, data safety monitoring committees, and appropriate ethical and regulatory requirements. (Capability 1.3, 2.1, 3.1, 4.1, 4.2, 5.1, 5.2 and 6.1)

Assessments

Assessment Type Percentage Classification
Assignments 40% Individual Coursework
Assignments 60% Individual Coursework
Assessment Type Learning Outcome Addressed
1 2 3 4 5
Assignments
Assignments

Workload Expectations

This course is a standard 15 point course and students are expected to spend 10 hours per week involved in each 15 point course that they are enrolled in.

The course requires you to attend one full day of teaching (8.30am - 4.30pm, including breaks) each month, over a period of four months. For this course, you can expect 6 hours of lectures on each block day,  46 hours of reading and thinking about the content and 70 hours of work on assignments.

Delivery Mode

Campus Experience

Attendance is expected at scheduled lectures to receive credit for all components of the course.
Lectures will be available as recordings. 
The activities for the course are scheduled as block delivery.

Learning Resources

Course materials are made available in a learning and collaboration tool called Canvas which also includes reading lists and lecture recordings (where available).

Please remember that the recording of any class on a personal device requires the permission of the instructor.

Required reading will consist of relevant  journal articles and reports made available on CANVAS. The text for this course is "Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 5th edition. Springer: New York. 2015". The book can be ordered from the University Bookshop (UBS) and Amazon. The e-book can be viewed on-line or downloaded via the University Library.  

Student Feedback

At the end of every semester students will be invited to give feedback on the course and teaching through a tool called SET or Qualtrics. The lecturers and course co-ordinators will consider all feedback and respond with summaries and actions.

Your feedback helps teachers to improve the course and its delivery for future students.

Class Representatives in each class can take feedback to the department and faculty staff-student consultative committees.

Other Information

Sessions will generally adopt an interactive lecture format ,with opportunity for informal discussion and questions, practical exercises, group work, and class presentations. Experts in the design, analysis and conduct of clinical trials will present at all sessions. 

Academic Integrity

The University of Auckland will not tolerate cheating, or assisting others to cheat, and views cheating in coursework as a serious academic offence. The work that a student submits for grading must be the student's own work, reflecting their learning. Where work from other sources is used, it must be properly acknowledged and referenced. This requirement also applies to sources on the internet. A student's assessed work may be reviewed against online source material using computerised detection mechanisms.

Class Representatives

Class representatives are students tasked with representing student issues to departments, faculties, and the wider university. If you have a complaint about this course, please contact your class rep who will know how to raise it in the right channels. See your departmental noticeboard for contact details for your class reps.

Inclusive Learning

All students are asked to discuss any impairment related requirements privately, face to face and/or in written form with the course coordinator, lecturer or tutor.

Student Disability Services also provides support for students with a wide range of impairments, both visible and invisible, to succeed and excel at the University. For more information and contact details, please visit the Student Disability Services’ website http://disability.auckland.ac.nz

Special Circumstances

If your ability to complete assessed coursework is affected by illness or other personal circumstances outside of your control, contact a member of teaching staff as soon as possible before the assessment is due.

If your personal circumstances significantly affect your performance, or preparation, for an exam or eligible written test, refer to the University’s aegrotat or compassionate consideration page https://www.auckland.ac.nz/en/students/academic-information/exams-and-final-results/during-exams/aegrotat-and-compassionate-consideration.html.

This should be done as soon as possible and no later than seven days after the affected test or exam date.

Learning Continuity

In the event of an unexpected disruption, we undertake to maintain the continuity and standard of teaching and learning in all your courses throughout the year. If there are unexpected disruptions the University has contingency plans to ensure that access to your course continues and course assessment continues to meet the principles of the University’s assessment policy. Some adjustments may need to be made in emergencies. You will be kept fully informed by your course co-ordinator/director, and if disruption occurs you should refer to the university website for information about how to proceed.

The delivery mode may change depending on COVID restrictions. Any changes will be communicated through Canvas.

Student Charter and Responsibilities

The Student Charter assumes and acknowledges that students are active participants in the learning process and that they have responsibilities to the institution and the international community of scholars. The University expects that students will act at all times in a way that demonstrates respect for the rights of other students and staff so that the learning environment is both safe and productive. For further information visit Student Charter https://www.auckland.ac.nz/en/students/forms-policies-and-guidelines/student-policies-and-guidelines/student-charter.html.

Disclaimer

Elements of this outline may be subject to change. The latest information about the course will be available for enrolled students in Canvas.

In this course students may be asked to submit coursework assessments digitally. The University reserves the right to conduct scheduled tests and examinations for this course online or through the use of computers or other electronic devices. Where tests or examinations are conducted online remote invigilation arrangements may be used. In exceptional circumstances changes to elements of this course may be necessary at short notice. Students enrolled in this course will be informed of any such changes and the reasons for them, as soon as possible, through Canvas.