Performing Clinical Trials for ATMPS
Like other drugs, you need to prove that the administration of your ATMP is safe and effective for the patient, and so you need to conduct clinical trials specific to your ATMP. To do this, you follow the same processes, procedures, regulations and so on as clinical trials with other drugs, but on top of that you will encounter additional challenges and have to follow additional regulations. This module will discuss some basic principles of clinical trials, the regulatory framework, the different phases of a clinical trial and the roles and responsibilities of different stakeholders and, where appropriate, focus on the specificities of ATMP clinical trials.
Learning Objectives
In this course, you will learn
- where the ethical guidelines for clinical trials originated and what is the current (and future) regulatory framework within which you must conduct clinical trials for ATMPs
- about the flow of a clinical trial and what you need to achieve at each of the different stages of a clinical trial
- who the different stakeholders in a clinical trial are and what their roles and responsibilities are
- how to ensure quality of clinical research, including GDPR and risk management
- how to design a clinical trial protocol and how to take into account the specific challenges for ATMPs
- the most important key factors that will make your clinical trial successful