General principles and methods applied to clinical drug development will be covered in this teaching.
The expected learning outcomes are as follows:
- Knowledge and understanding skills: to know, interpret and understand the general principles, methods and tools adopted in the clinical drug development process; the different types of clinical trial design, the roles of the ethics committee and CROs. In addition, the student will acquire the ability to critically analyze the design of a clinical trial and thus be able to evaluate and interpret the data reported in the scientific literature. - Ability to apply knowledge and understanding: the knowledge acquired will enable the student to understand the various phases of clinical drug development; distinguish and discriminate the different purposes of different types of study design. - Know how to evaluate the importance of regulation and ethics in clinical research. - Soft skill: Communicate concepts related to clinical trials with clarity and good command of language; critically analyze scientific literature; understand the importance of ethics in trials.
Teaching Methods
Lectures will be face-to-face according to the predetermined timetable. Interventions from students are encouraged in order to identify any critical issues in learning.
Assessment Methods
The final examination will consist of an oral interview, with an exposition of a topic of your choice pertaining to the course and questions on the entire program. The vote will be expressed with concise judgements.
Texts
-Shamley D. Ed C., Wright B. A Comprehensive and practical guide to clinical trials. Academic Press; 1 edizione (11 giugno 2017). ISBN-10: 0128047291; ISBN-13: 978-0128047293 -https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice-scientific-guideline -REGOLAMENTO (UE) N. 536/2014 DEL PARLAMENTO EUROPEO E DEL CONSIGLIO del 16 aprile 2014
Contents
- Introduction to Clinical Trials - Stages of Clinical Development - Regulation and Ethics - The protocol and informed consent - Methodology of Clinical Research - The actors in clinical trials
