STATS 773 : Design and Analysis of Clinical Trials


2022 Semester Two (1225) (15 POINTS)

Course Prescription

The theory and practice of clinical trials, including: design issues, data management, common analysis methodologies, intention to treat, compliance, interim analyses and ethical considerations.

Course Overview

This is a course on how to design and analyse clinical trials -- randomised experiments comparing medical interventions when we don't know which one is best. While there is some statistical theory involved, a lot of what is known about clinical trials comes from practical experience that the field has accumulated over the past few decades. 

Course Requirements

Prerequisite: 15 points from BIOSCI 209, STATS 201, 207, 208, 707

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 Science

Learning Outcomes

By the end of this course, students will be able to:
  1. Present and discuss bioethics principles relevant to clinical trials and their application in practical examples (Capability 1, 2, 5 and 6)
  2. Explain why randomised trials can compare interventions reliably (Capability 1, 2 and 4)
  3. Critically evaluate alternatives for outcome, comparator, and summary statistic (Capability 1, 2, 3 and 4)
  4. Explain why interim analyses are used and how they work (Capability 1, 4 and 6)
  5. Calculate sample size or power for common trial configurations (Capability 1 and 3)
  6. Distinguish data incompleteness due to censoring, missing data, dropout, and death (Capability 1 and 2)
  7. Summarise and communicate an area of clinical trial methodology (Capability 2, 3 and 4)


Assessment Type Percentage Classification
Assignments 20% Individual Coursework
Project 40% Group & Individual Coursework
Final Exam 40% Individual Coursework
Assessment Type Learning Outcome Addressed
1 2 3 4 5 6 7
Final Exam

Key Topics

Introduction to randomised trials and their history
Scientific issues in design: choice of outcome, control, comparison
Power and sample size
Statistical issues in analysis
Non-inferiority studies
The drug development process and its regulation
Approaches to randomisation: stratification, clusters, factorial designs
Governance and documentation: trial protocols, analysis plans, data handling, record keeping
Ethics: randomisation, vulnerable populations, scientific misconduct
Survival analysis
Monitoring and interim analysis
Pharmacogenetics and other individualized treatment problems
Missing data 
Meta-analyses and systematic reviews.

Special Requirements


Workload Expectations

This course is a standard 15 point course and students are expected to spend 150 hours per semester involved in each 15 point course that they are enrolled in.

For this course, you can expect about 3 hours of lectures, 3 hours of reading and thinking about the content and 6 hours of work on assignments and/or test preparation per week.

Delivery Mode

Campus Experience or Online

This course is offered in two delivery modes:

Campus Experience

Lectures will be available as recordings. 
The course will not include live online events including group discussions/tutorials.
Attendance on campus is required for the exam and the final project presentation
The activities for the course are scheduled as a standard weekly timetable.


Attendance is [required/expected] at scheduled online activities including [labs/tutorials/studios/clinics] to [complete/receive credit for] components of the course.
The course will include live online  lectures and these will be recorded.

Attendance online is required for the final project presentation

Attendance on campus is not required for the exam.

Where possible, study material will be released progressively throughout the course.

This course runs to the University semester/quarter timetable and all the associated completion dates and deadlines will apply.

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.

Student Feedback

During the course Class Representatives in each class can take feedback to the staff responsible for the course and staff-student consultative committees.

At the end of the course 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.

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

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.


The content and delivery of content in this course are protected by copyright. Material belonging to others may have been used in this course and copied by and solely for the educational purposes of the University under license.

You may copy the course content for the purposes of private study or research, but you may not upload onto any third party site, make a further copy or sell, alter or further reproduce or distribute any part of the course content to another person.

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

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

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


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.

Published on 11/11/2021 09:33 a.m.