Image

Early Phase Trials

Early Phase Trials

Annamária Németh
University of Szeged, Hungary

Aim
The aim of the lesson is to provide comprehensive knowledge to students on the topic of early phase (0, I, and II) studies. We will discuss the difficulties of determining the first human dose, dose concepts, study design, risk minimization, the roles and tasks of study participants, and role and screening of the volunteers. By the end of the chapter, students can understand the differences between early and later phases of clinical studies, can have a knowledge of the differences between phase 0, I, and II, as well as other specific types of early trials and understand the characteristics of these phases. Throughout the practical examples they can discover the complex process of trial design.

Summary
In this chapter, we will study the types of early phase trials, and their role within drug development. We also take a look at the typical design features of early trials, as well as the methods to evaluate their results. By the end of this chapter, students will get a complete picture of early phase trials, since beyond the theoretical background, we concentrate also on practical examples and challenges.
Medicines typically pass through many different trial phases before they are adopted as part of standard of care. Early phase clinical trials, colloquially those at phases I and II, primarily investigate the safety profile, seek to identify promising doses and first assessments of effects in the target disease of a new medicine. They typically use methodological designs quite distinct from traditional phase III trials. Results of early phases of trials provide the basis for subsequent investigations and methodological errors at this stage can compromise the rest of the drug development pathway.

Outline

Chapter 7- Early Phase Trials (University of Szeged, Szeged, Hungary)

Final chapter

Chapter 7- Early Phase Trials (University of Szeged, Szeged, Hungary)