Doel vak

- 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

Inhoud vak

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.

Onderwijsvorm

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

Toetsvorm

Written exam: 100%

Literatuur

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).

Doelgroep

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

Overige informatie

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