Epidemiology and Clinical Trials

Course Objective

• To gain knowledge and insight into the basic concepts of epidemiology, epidemiological study designs and clinical trials
• To be able to understand, calculate and apply epidemiological and screening measures
• To be able to understand and assess errors/bias, confounding and effect modification in epidemiological/clinical studies
• To gain knowledge and insight into the design of clinical trials
• To gain knowledge and insight into the conduct of clinical trials with application of rules and regulations (including ICH-GCP)
• To be able to understand and critically reflect on the roles, tasks and responsibilities of the stakeholders involved in clinical trials

Course Content

This course comprises of two components: (1) Epidemiology and (2) Clinical development and Clinical Trials. The course will begin with understanding and application of the basic principles, concepts and measures in Epidemiology, followed by a deeper exploration of design, conduct and critical reflection on Clinical development and Clinical trials.

Component 1: Epidemiology

Epidemiology is the study of the distribution and determinants of health-related states or events in populations, and the application of this study to the prevention, control and treatment of health problems. It is a crucial field of study for all health professionals (healthcare workers, public health practitioners, researchers, managers, administrators, policy makers, etc.) .

The  basic Epidemiology component in this course consists of a theoretical, contextual, and practical elements. The theoretical component will focus on concepts and methodology used in epidemiological studies (e.g. study-designs, measures of occurrence and association, screening, bias, etc.). The contextual component will focus on past and current epidemiological developments, for instance, the start of the HIV/AIDS pandemic. Lastly, the practical component will focus on application of all your new skills through workgroups.

Component 2: Clinical Development and Clinical Trials

In today’s healthcare system, of the many different types of epidemiological studies - 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 component in this 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’.

Additional Information Teaching Methods

• Lectures
• Work groups
• Assignment(s)
• Self-study

Please note that guest lectures are mandatory. Students will be notified in advance of the guest lectures in the course where students are expected to be present mandatorily.

Workgroups are mandatory for all students. There is mandatory attendance for the workgroups. If you somehow will not be able to attend one of the workgroup sessions, you are required to inform your workgroup tutor. You will receive an alternative assignment. Students cannot miss more than two workgroups, which will lead to insufficiency in passing and completing the course.

Method of Assessment

• Exam (65%)
• Individual assignments (15%)
• Group assignment (20%)

Literature

Available on Canvas

Additional Information

For more information contact course coordinators: Dr. Sarju Sing Rai (s.s.rai@vu.nl) & Dr. Anne van der Geest (a.m.vander.geest@vu.nl)

Use of Generative AI (GenAI)

This course follows the BETA Faculty policy on GenAI use. Use

GenAI responsibly and in line with the VU academic integrity policy and the VU recommendations on responsible use of GenAI.