Clinical Development

Abstract

The course provides an introduction into the clinical development process of drug products. Underlying principles of evidence-based medical science and the ethical/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, evidence-based 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 • Data management and analysis. Use of AI tools • Study Documentation: overview and explanation of relevant documents including Trial Master File with contents, Standard Operating Procedures. • Quality Aspects: monitoring, audits, issue management

Resources