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Workshop - Introduction to Clinical Trial Design - May 22-23

  • 10 Mar 2023 11:47 AM
    Message # 13126217
    Deleted user

    Cost $550AUD
    For more information see

    Clinical trials are used within a range of health fields as we seek to understand the level of benefit (and harm) from different interventions (such as pharmaceuticals, patient therapies, and health promotion campaigns). A well-designed clinical trial has a clear strategy for aspects such as patient recruitment, the timing and dose of interventions, and the scheduling of data collection.

    Session 1 - Introduction to Clinical Trials
    * Types of Clinical Trials - Drugs, Devices, Health Prevention, Complementary or Alternative Medicine, Surgery and Skill-Dependent Therapies
    * Objectives and Outcomes - determining what to measure

    Session 2 - Validity and Reliability
    * Validity - the relationship between the measured variable and the underlying construct
    * Reliability - if we measure the same thing (maybe under different conditions) will we obtain the same measurements
    * Methods for assessing validity and reliability

    Session 3 - Introduction to Study Design
    * Experimental versus observational studies
    * Ethics
    * Choice of study cohort
    * Clinical trial design
    * Superiority versus non-inferiority

    Session 4 - Treatment Allocation
    * Placebos
    * Replication
    * Randomization
    * Blocking
    * Stratification
    * Adaptive allocation
    * Minimization
    * Groups of unequal sizes

    Session 5 - Factiorial and Cross-over Designs
    * Treatment interactions
    * Factorial designs
    * Cross-over designs
    * Analysis of data from different designs
    * Sample size calculations

    Session 6 - Diagnostic Tests
    * Choosing the threshold for a diagnostic measure
    * Classification tables
    * Odds and Relative Risk
    * Receiver Operating Characteristic (ROC) curves
    * Factoring in the cost of making different kinds of mistakes
    * Generalizability

    Session 7 - Missing Values
    * Response rates
    * Missing Completely At Random, Missing At Random, Missing Not At Random
    * Understanding and addressing the reasons for missing data
    * Multiple imputation

    Session 8 - Computer Exercise Session (Basic exercises in Excel)
    * Treatment allocation (randomization, minimization)
    * Study design (factorial designs, cross-over designs, sample size calculations)
    * Diagnostic tests

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