Period: 05 September 2022 - 23 September 2022
Clinical pharmacology is the study of drugs in humans. It is underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world (from R&D to patient care). The discipline is heavily involved during the research, development an application of (new) medicines. Over the last two decades the discipline has evolved considerably due to a couple of simultaneously occurring developments that will be addressed in the course.
1) We will review why there has been a tremendous increase in scientific knowledge over the past decades, but why clinical trials in humans are (largely) performed in a rather orthodox manner, comparable to clinical trials 40 years ago.
2) Another interesting development is the greater emphasis on biomarkers to assess drug action in humans. The development of biomarkers, their advantages and their problems will be discussed.
3) The role of pharmacogenetics and pharmacogenomics in current drug development as well as the efforts that are performed to link drug concentrations to drug effects will be addressed. Inspired by these developments, the hope is that in the near future we enter the era of ‘personalized medicine’. This term has been coined to indicate that it should be possible to treat each individual patient with a personally tailored treatment.
Finally, the course aims to show how to design a clinical trial and execute it. A substantial part of the course is dedicated to a class-room experiment where both pharmacodynamics, pharmacokinetics, and pharmacogenomics of a model drug are investigated.
The main objective of the course is to gain more insight in the application of novel techniques that are applied in pre-clinical and clinical drug research. At the end of this module you:
understand basic pharmacological principles from pharmacodynamics and pharmacokinetics
are aware of exponential increase in the identification of possible ‘drugable’ targets and why this has not necessarily translated into drug targets.
know the process of drug development and can distinguish the different phases understand the basic concept of pharmacogenomics and know its implications for pharmacotherapy .
have obtained knowledge and experience in the application of novel techniques that are applied in pre-clinical and clinical drug research .
are able to discuss advantages and problems following the growing emphasis on biomarkers to assess drug action in humans .
are able to set-up a simple clinical trial, where you can:
o write a research synopsis
o conduct relevant research activities related to a self-made research plan, thus executing basic protocol related activities adequately as well as analyzing the gathered data
o analyze and present gathered relevant data and thereby applying scientific sound research techniques
understand basic clinical pharmacological principles and communicate this knowledge to laymen in a state-of-the art way.
All course and group schedules are published on our LUMC scheduling website or on the LUMC scheduling app.
Mode of instruction
In this course various teaching methods are applied. As the cohort is small, the basic lectures are set-up as interactive tutorials. There are various group assignments, case studies and one project work followed by peer-discussions.
During the course, multiple assignments will be made by the student, partially graded 1-10, the remaining assignments are graded for participation (insufficient/sufficient mark). Each assignment will be discussed during at the beginning of the course, and depending on the number of participants, the final expectations for the group assignments will be presented.
Assignments 1-3 (Graded 1-10)
The final grade is composed of 3 parts:
Assignment 1: Individual mark for the quiz/test 30%
Assignment 2: Individual mark for the Design a Clinical Trial 30%
Assignment 3: Clinical trial results:
a) Group mark for final presentation 10%
b) Group mark for the final report (with individual components) 30%
In addition, 4 assignments need to be successfully completed in order to pass the course (pass/no pass).
Assignment 4: Creation of a personalized CYP2D6 drug passport
Assignment 5: The Clinical Pharmacology Movie
Assignment 6: PK exercises (Individual)
Assignment 7: IB derisk assessment
Will be distributed during the course.
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