Clinical Trials and Health Care

COURSE OBJECTIVE

• 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 interventions.
• Gain insight in the need for and practice of a systemic perspective on innovation.
• 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.

COURSE CONTENT
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 clinical trials?

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.

TEACHING METHODS
 Lectures, work groups, a group project and self-study. 

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.