Clinical Development and Clinical Trials

2018-2019

Course Objective

- To gain knowledge and insight into the function clinical trials in
today's healthcare system
- To gain knowledge and insight into the design of clinical trials
- To gain knowledge and insight into the conduct of clinical trials,
including the applying rules and regulations (including ICH-GCP)
- To gain knowledge and insight into and critically reflect on the
roles, tasks and responsibilities of the stakeholders involved in
clinical trials
- To gain insight into challenges in clinical development as well as in
strategies to deal with these challenges
- To learn where and how to look up rules and regulations

Course Content

In today’s healthcare system, clinical trials have gained the status of
golden standard to test the safety and efficacy of newly developed
drugs. For new drugs to enter the market, clinical trials must be passed
and as a consequence, clinical trial outcomes have major effects on our
healthcare system. While our healthcare system currently is under
pressure to remain affordable and available to all, at the same time,
clinical trial regulations are increasingly tightened and the prominence
of clinical trials in our healthcare system is being criticized. For
that matter, it is of great importance to learn about and reflect on the
role of clinical trials in today’s healthcare system.

The Clinical Development & Clinical Trials course will elaborate on the
function, design and conduct of clinical trials, as well as the relevant
stakeholders involved. The course consists of a theoretical part and an
important practical part (e.g. gaining knowledge on clinical trial
regulations). Classes include for example: ‘Life Cycle of a Clinical
Trial’, ‘Clinical Trial Methodology’, ‘ICH-GCP Principles’, ‘The Ethics
Committee’, ‘Safety Considerations in Clinical Trials’, ‘Quality Control
& Quality Assurance’, ‘Compliance, Misconduct & Fraud’.

The gained knowledge and skills will be evaluated by means of a written
exam at the end of the course.

Teaching Methods

Lectures: +-35 h
Self study: +- 40 h

Method of Assessment

Written exam: 100%

Literature

Ray, S., Fitzpatrick, S., Golubic, R. & Fisher, S. (2016). Oxford
Handbook of Clinical and Healthcare Research. Oxford University
Press,Oxford, UK.
(Additional reading will be provided via Canvas and will serve as
background reading for the lectures).

Target Audience

Optional course for Master students Management, Policy Analysis and
Entrepreneurship in Health and Life Sciences (MPA), Societal
differentiation of the Health, Life & Natural Sciences.

Additional Information

Guest lecturers, organisations/companies:
• Eric Klaver, FourPlus Clinical

General Information

Course Code AM_1180
Credits 3 EC
Period P3
Course Level 500
Language of Tuition English
Faculty Faculty of Science
Course Coordinator drs. ing. E.M. Janse
Examiner prof. dr. H.J.H.M. Claassen
Teaching Staff prof. dr. H.J.H.M. Claassen

Practical Information

You need to register for this course yourself

Last-minute registration is available for this course.

Teaching Methods Study Group, Lecture
Target audiences

This course is also available as: