POPLHLTH 712 - Clinical Trial Design, Analysis and Management

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

Prerequisite: POPLHLTH 708 or POPLHLTH 709 or equivalent epidemiology experience/knowledge of clinical epidemiology.

An understanding of basic statistics is required.

This course is one of a number of courses offered in the School of Population Health that have an evidence based focus. It is a required course for the Postgraduate Certificate in Public Health in Effective Practice.

Content Outline

The course will cover the following topics:

• The rationale for clinical trials.
• An overview of elements essential to building a research question and choosing an appropriate trial design.
• Outcome selection, sample size calculation and randomisation.
• Planning and conducting a clinical trial, including budgeting, obtaining funding, strategies to address likely difficulties with conduct, data management, and managing missing data.
• Ethics and data analysis, including an overview of Good Clinical Research Practice, ethics in New Zealand, data monitoring, and appropriate statistical analyses.

Each day will focus on a specific type of trial design:

Day 1: Multi-arm trials
Day 2: Cluster and stepped wedge
Day 3: Factorial, cross-over and n-1 trials
Day 4: Complex trials

Goals of the Course

• To provide an overview of the practical aspects of phase III and pragmatic clinical trial design, analysis and management
• To equip the course participant with some of the essential skills required to design and conduct a research project, and to evaluate research findings
• To equip the course participant with some of the essential skills required to write grant applications for research funding

Learning Outcomes

Following the course students should be able to:

• Formulate a research question that includes key patient and health care setting specific components
• Make suitable choices on design elements that impact on internal & external validity
• Understand the statistical issues underpinning good quality analyses
• Develop a study protocol for a randomised controlled trial

This course is 100% internally assessed on the basis of two assignments to be completed by the due dates in the second semester. The assignments are sequential, with each building on the issues addressed and skills acquired in the previous assignment.

Assignment 1 (40%) – Background to a study protocol. This will be an individual assignment providing the background and rationale for a research question of the student’s choosing.

Assignment 2 (60%) – Study protocol for a RCT. This will be an individual assignment involving the completion of a study protocol (including the background and research question from assignment 1).

The course will be held at the School of Population Health in the University of Auckland's Grafton Campus. Sessions will generally adopt an interactive lecture format with opportunity for informal discussion and questions, practical exercises, and group work. Experts in the design, analysis and/or conduct of clinical trials will present at all sessions.

Please see your timetable on SSO for the room details.

Learning Resources 

• 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 online, downloaded or requrested in physical form via the University Library.
  
• Additional reading recommendations and resources available on CANVAS