Course syllabus for Design and analysis of clinical trials

The course syllabus contains changes
See changes

Course syllabus adopted 2020-03-12 by Head of Programme (or corresponding).

Overview

  • Swedish nameDesign och analys av kliniska försök
  • CodeMVE200
  • Credits7.5 Credits
  • OwnerMPENM
  • Education cycleSecond-cycle
  • Main field of studyMathematics
  • DepartmentMATHEMATICAL SCIENCES
  • GradingTH - Pass with distinction (5), Pass with credit (4), Pass (3), Fail

Course round 1

The course round is cancelled. This course round is planned to be given every other year. For further questions, please contact the director of studies
  • Teaching language English
  • Application code 20147
  • Open for exchange studentsNo

Credit distribution

0108 Examination 7.5 c
Grading: TH		 7.5 c

In programmes

Examiner

  • Ziad Taib
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Eligibility

General entry requirements for Master's level (second cycle)
Applicants enrolled in a programme at Chalmers where the course is included in the study programme are exempted from fulfilling the requirements above.

Specific entry requirements

English 6 (or by other approved means with the equivalent proficiency level)
Applicants enrolled in a programme at Chalmers where the course is included in the study programme are exempted from fulfilling the requirements above.

Course specific prerequisites

Calculus-based probability and mathematical statistics will be used throughout. Many area of statistical inference can be useful in the context of clinical trials (categorical methods, linear models, mixed models, survival analysis etc). Because of that, the more knowledge the student have the better he or she will be able to assimilate the content of this course. Minimum requirement is a course in Statistical linear models.

Aim

The aim of the course is to give theoretical and practical knowledge about design and analysis of clinical trials.

Learning outcomes (after completion of the course the student should be able to)

After completing the course the student will be able
- to recognize common study designs in clinical trials and explain
their rational,
- to perform statistical analysis appropriate for various
designs covered in the course using software packages.

Content

The clinical trial protocol, sources of bias in clinical trials, blinding,
randomization,
sample size calculation; design and analysis of phase I, phase II, phase
III and
hybrid trials; interim analysis, non-inferiority studies; stochastic
curtailment, Bayes
designs, and administrative issues in study design.

Organisation

Lectures, computer exercise classes.

Literature

Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley
Series in Probability and Statistics) (Hardcover) by Shein-Chung Chow,
Jen-Pei Liu plus some handouts.

Examination including compulsory elements

Home assignments and written final examination.

The course syllabus contains changes

  • Changes to course rounds:
    • 2020-03-12: Cancelled Changed to cancelled by UOL
      [Course round 1] Cancelled