• Acquire insight into the process and wider context of clinical trials.
• Obtain knowledge and insight into the juridical and financial factors
concerning clinical trials and innovation processes.
• Gain insight into societal and political responses to scientific
uncertainties surrounding clinical trials, safety and innovative health
• Gain insight in the need for and practice of a systemic perspective on
• Be able to form lines of argumentation and participate in debate in
the context of specific cases and team assignments.
• Be able to apply practical and theoretical skills, such as conducting
a literature study, critically analysing various scientific
publications, hypotheses and arguments, and justifying and presenting
findings both orally and in writing.
• Get acquainted with interdisciplinary (gamma-beta) research.
Clinical trials are a crucial step in the development process of many
health interventions (e.g. new drugs, diagnostics, medical devices and
therapy protocols). By setting up carefully designed quantitative
experiments, new interventions are tested for safety, efficacy and
cost-effectiveness on human beings (initially healthy volunteers, later
patients). In many countries clinical trials are required before the
national regulatory authority allows the drug, device or therapy to be
marketed and used on patients. Clinical trials are, however, not
unproblematic. There are various accounts of prematurely terminated
trials because of serious side effects or high death rates in the
interventional arm of the study. Furthermore, some of the tested
interventions have raised ethical concerns, because they involved the
use of a controversial technology like stem cell therapy, or were
conducted in a developing country without appropriate safety measures.
There are also difficulties encountered in recruiting sufficient numbers
of volunteers in experiments. Frustrated by being only treated as
‘subjects’, patients increasingly demand a ‘say’ in the design and
implementation of clinical trials. From a governmental perspective, the
former innovative power that improved health care is now more and more
seen as a financial burden. And last, there are severe problems for the
industry that is behind these clinical innovations. The pharmaceutical
industry is facing tremendous pressure, not only from payers, but as a
result of public perception, regulatory hurdles, and the intricacies of
research and development (R&D). Overall, medical (and especially drug)
development has been stagnant in terms of innovation, and failure to
innovate the developmental process itself will render the “Big Pharma”
model unsustainable. How to deal with this?
Central in this course is the idea that a systemic perspective, i.e. the
involvement of relevant stakeholders in the innovation process, can
benefit both quality and successful implementation of new products. In
the course, the ins and outs of the process of clinical trials are
discussed. How do you do a trial; what actors and factors are involved?
Based on that, recent debates around clinical trials are highlighted.
How can we assess and manage risks if there is uncertainty about how the
risks look like? What precautions should we take from a medical and
societal perspective before we decide to (not) start a clinical trial?
Can, and should, patients be involved in the decision process around
In teams of four to six students, you search and collect research data
from the lectures and from scientific papers and build a portfolio.
Every workgroup meeting, debates will be held based on the gathered
information, thus sharpening your discussion skills and deepening your
knowledge about the latest scientific developments and the role of
clinical trials to protect patients, consumers and societies.
Form of tuition
Tuition methods include lectures, work groups, a group project and
The different elements have the following study time:
- lectures 24 hours
- work groups 16 hours
- group project 32 hours
- self study (including portfolio assignment and exam) 98 hours
Type of assessment
The final grade is the sum of the exam (60%) and the group-project
portfolio and research assignment (40%). Both need to be passed, because
both test different competences.
On Canvas you will find literature for every lecture. This
literature will become part of your portfolio. For your research
assignment you need to find literature yourself.