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Design and Analysis of Biomedical Studies


Admission requirements


This four-week course is about research methods for biomedical (pre-clinical and clinical) studies. The course aims at providing basic knowledge of frequently used study designs and methods for the analysis of data resulting from biomedical studies. Students actively work with these designs and methods, and learn to discuss strengths and weaknesses. Three themes will be central in this course:

Design Choices between different study designs in animals or in humans, such as case-control, follow-up, randomized controlled trials will be discussed, as well as aspects specific to each of the study designs, for instance the choice of controls, cross-over vs. parallel, randomisation, and blinding.

Analysis Statistical methods to analyze data from these studies will be taught and actively used. Methods include univariate and multivariate linear regression, logistic regression, survival analysis (Kaplan Meier survival curves and Cox regression), and linear mixed models.

Interpretation and validation Interpretation of the results involves the interpretation of relative risks, odds ratios and hazard ratios in univariate and multivariate analyses. Validation of the methods involves model checks, the reliability of measurements (inter- and intraobserver variation, kappa), the evaluation of diagnostic systems (ROC curves), and recognition of the principles of bias and confounding. Other aspects discussed are literature search, database use and ethical aspects.

Course objectives

The student is able to:

  • Perform database searches for literature (PubMed and Web of Science) and biological items and concepts (such as OMIM, LOVD, Anni) and account for the method of literature searching by following reproducible methodology

  • Perform a comprehensive literature search for the design of a biomedical study by following reproducible methodology

  • Translate a clinical problem into a research question

  • Explain methods of study design used in a clinical or population setting, and knows how these studies are performed

  • Design a biomedical study in an efficient way

  • Choose, apply and interpret the most appropriate statistical analyses

  • Evaluate the reliability and reproducibility of measurement systems

  • Recognize and discuss the possibility of bias and confounding in a study

  • Discuss ethical and legal aspects of clinical studies with human subjects


All course and group schedules are published on MyTimeTable.

The exam dates have been determined by the Education Board and are published in MyTimeTable.
It will be announced in MyTimeTable and/or Brightspace when and how the post-exam feedback will be organized.

Mode of instruction

This course consists of a number of lectures, 4 working groups, 9 self-study assignments, and 6 computer practicals. During working groups and practicals, students will work together om pairs, or in small groups.

Assessment method

Students will be evaluated by preparing a protocol and presentation for an animal experiment (pass), a written report on a clinical trial (pass), a written report of each of the computer practicals (pass), and an examination (tentamen, 100% of final grade).

The exam contains both multiple choice and “open questions”. The final grade is published in uSis as soon as requirements have been met. There is a re-examination during spring.

Reading list

You can find the complete reading list for Biomedical Sciences here.


Registration must be done via MyStudyMap. Registration in MyStudyMap gives you automatic access to the course in Brightspace. For more information, please visit the Leiden University website for students.



Information for exchange students
This module is part of an English taught third semester of the bachelor’s programme in Biomedical Sciences at Leiden University Medical Center. HOWEVER, PLEASE NOTE THAT INSTEAD OF THE REGULAR MODULE, EXCHANGE STUDENTS WILL FOLLOW TWO MASSIVE OPEN ONLINE COURSES ON STATISTICS AND EPIDEMIOLOGY. Combining biomedical modules with modules from other programmes in Leiden is difficult or impossible due to different scheduling schemes. Exchange students with sufficient relevant background knowledge in biology/biomedicine are therefore encouraged and advised to choose the entire module package indicated (by an *) below.

Immunology (BW), 9 EC*
Infectious Agents And Immunity, 6 EC*
Introduction to the Neurosciences 6, EC*
Design and analysis of Biomedical Studies, 6 EC*