Clinical Development

Abstract

The course provides an introduction into the clinical development process of drug products. Underlying principles of medical science, ethics and the legal framework are covered. Next to the theoretical background there is a strong focus on applying the gained knowledge through interactively designing a clinical study, analyzing study data and dealing with operational issues.

Objective

• Students can explain the basic the principles of clinical trials in modern medicine. • Students can summarise the ethical- and legal framework around clinical studies. In particular, they understand how the rights of patients participating in clinical studies are protected. • Students can explain the clinical development process, the different phases thereof and the role of clinical development in overall product development. • Students can summarise the operational aspects of executing a clinical study. • Students can explain statistical principles of clinical trials and the role of data management. • The students can apply their gained knowledge in clinical development in simulated exercises around clinical trial design and execution

Content

• Relevant principles of modern medicine • Overview of Clinical Development: basic scientific principles, translation from pre-clinical data, study phases I-IV, study operations, logistics • Regulatory/Ethical Framework • Patient safety: control procedures, reporting of side effects • Clinical trial design and reporting/publishing of results • Study Documentation: overview and explanation of relevant documents including Trial Master File with contents, Standard Operating Procedures. • Quality Aspects: monitoring, audits, issue management

Resources