GSMS Course Registration

All GSMS courses

Only GSMS PhD students (including BCN PhD students) can participate in these courses. Use your P-number to register (ask your Personnel Office).

For registration please go to Upcoming courses.

Course: Phase II/III Clinical Trials

Clinical trials are conducted to demonstrate the efficacy and safety of new interventions (e.g. drugs, medical devices, surgical procedures, or public health changes) in a predefined target population. The efficacy is the therapeutic effect measured by a relevant clinical outcome (e.g. improve life expectancy, cure the disease, increase quality of life) and safety is possibly measured by side effects and evaluated in relation to the therapeutic effect. Introducing new interventions requires in principle three phases of clinical trials before it can be approved by the appropriate authorities. This course focuses mainly on the methodology for the second and third phase of clinical trials.

At the end of the course, the participants:

  • Have general knowledge on clinical trials
  • Have detailed knowledge on methodological issues in phase II/III trials

At the end of the course, the participants should be able to:

  • Describe the different phases in the clinical development program of a medicine
  • Explain the difference between  uncontrolled and comparative designs for phase II clinical trials
  • Describe Simon’s optimal two-stage designs for phase II clinical trials
  • Perform sample-size calculations for phase II clinical trials
  • Describe different designs for phase III clinical trials, including parallel-group design, cluster randomized designs, and stepped wedge designs
  • Describe different randomization strategies for parallel-group designs, including complete randomization, random allocation rule, permuted-block randomization, and group randomization
  • Explain the difference between superiority, equivalence, and non-inferiority testing
  • Describe how regulators use the data collected in phase II/III clinical trials to reach an opinion regarding the marketing authorization of a new medicine

Literature
The course literature consists of a series of articles that are made available on Nestor.

EC (without exam)

1.5

Course coordinator

  • Douwe Postmus, PhD

Language

English

Contact person

Renate Kroese, r.c.kroese@umcg.nl

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