ID:
SCV0730
Duration (hours):
32
CFU:
4
SSD:
FARMACOLOGIA
Year:
2025
Overview
Date/time interval
Primo Semestre (25/09/2025 - 16/01/2026)
Syllabus
Course Objectives
The aim of the course “Clinical trials in Pharmacology” is to provide a basic knowledge on the clinical investigations leading either to the development of new drugs, or to the post-registration improvement/optimization of therapeutic interventions involving older drugs.
This course will complement the topics taught in other courses of the Biomedical Sciences master program by extending the knowledge of students to the translation of the results of biomedical investigation into the clinical research.
In particular, students will acquire the capacity:
-to understand the fundamental structure of phase I, II, III, IV clinical trials in their traditional or adaptive designs, and of meta-analysis of clinical trials;
-to understand the key concepts on the effective and ethical conduct of modern clinical research;
-to critically appraise the medical scientific literature, including the methodology, the results and the relevance of trial reports and trial protocols;
-to independently assess the most basic biases in clinical trial reports;
-to imagine the potential health impact of the results of a clinical trial.
This course will complement the topics taught in other courses of the Biomedical Sciences master program by extending the knowledge of students to the translation of the results of biomedical investigation into the clinical research.
In particular, students will acquire the capacity:
-to understand the fundamental structure of phase I, II, III, IV clinical trials in their traditional or adaptive designs, and of meta-analysis of clinical trials;
-to understand the key concepts on the effective and ethical conduct of modern clinical research;
-to critically appraise the medical scientific literature, including the methodology, the results and the relevance of trial reports and trial protocols;
-to independently assess the most basic biases in clinical trial reports;
-to imagine the potential health impact of the results of a clinical trial.
Course Prerequisites
The students should be proficient in anatomy, physiology, general pathology and pharmacology.
The students should also be familiar with the general structure of a scientific article in the biomedical/medical field.
The students should also be familiar with the general structure of a scientific article in the biomedical/medical field.
Teaching Methods
The course will include:
-a theoretical overview of the design, analysis and conduct of phase I, phase II, phase III, phase IV clinical trials, of modern adaptive studies and of meta-analyses of clinical trials. The lessons will be based on slide presentations and on the distribution of printed material (papers, questionnaires).
-a practical section, in which students will follow the development of a drug through classroom interactive reading of scientific articles (journal clubs). These articles will cover the complete history of a recently developed drug (“model drug”), spanning between phase I and phase IV studies, and also including trial meta-analyses.
This will be preceded by a thorough introduction to the disease for which the drug is indicated, which will include the anatomy, physiology, pathology and pharmacology of the condition.
-a theoretical overview of the design, analysis and conduct of phase I, phase II, phase III, phase IV clinical trials, of modern adaptive studies and of meta-analyses of clinical trials. The lessons will be based on slide presentations and on the distribution of printed material (papers, questionnaires).
-a practical section, in which students will follow the development of a drug through classroom interactive reading of scientific articles (journal clubs). These articles will cover the complete history of a recently developed drug (“model drug”), spanning between phase I and phase IV studies, and also including trial meta-analyses.
This will be preceded by a thorough introduction to the disease for which the drug is indicated, which will include the anatomy, physiology, pathology and pharmacology of the condition.
Assessment Methods
The evaluation of students’ proficiency will be based on written exams at the end of the course.
End-of-course exam: students will receive an article reporting the results of a clinical trial. After careful reading of the paper, they will be asked to answer a questionnaire concerning the trial.
End-of-course exam: students will receive an article reporting the results of a clinical trial. After careful reading of the paper, they will be asked to answer a questionnaire concerning the trial.
Contents
The main lecture topics will be:
-Clinical trials: background/introduction
-Outcome measures in clinical trials, basic statistics
-Overcoming bias in clinical trials: randomization, blinding, placebo
-Sample size and statistical power of a clinical trial
-Physiology, pathology and pharmacology of the disease for which the “model drug” is indicated
-Phase I trials (journal club on phase I trial(s) focusing on the “model drug”)
-Phase II trials (journal club: phase II trial(s) focusing on the “model drug”)
-Phase III trials (journal club: phase III trial(s) focusing on the “model drug”)
-Phase IV trials (journal club: phase IV trial(s) focusing on the “model drug”)
-Adaptive designs of clinical trials: basic principles (journal club on adaptive trial(s) focusing on the “model drug”)
-Principles of systematic reviews and meta-analysis of randomized controlled trials (journal club: one or more meta-analysis/ses focusing on the “model drug”)
-Clinical trials: background/introduction
-Outcome measures in clinical trials, basic statistics
-Overcoming bias in clinical trials: randomization, blinding, placebo
-Sample size and statistical power of a clinical trial
-Physiology, pathology and pharmacology of the disease for which the “model drug” is indicated
-Phase I trials (journal club on phase I trial(s) focusing on the “model drug”)
-Phase II trials (journal club: phase II trial(s) focusing on the “model drug”)
-Phase III trials (journal club: phase III trial(s) focusing on the “model drug”)
-Phase IV trials (journal club: phase IV trial(s) focusing on the “model drug”)
-Adaptive designs of clinical trials: basic principles (journal club on adaptive trial(s) focusing on the “model drug”)
-Principles of systematic reviews and meta-analysis of randomized controlled trials (journal club: one or more meta-analysis/ses focusing on the “model drug”)
Course Language
English
More information
Reference Textbook: Allan Hackshaw, A Concise Guide to Clinical Trials. BMJ Books. Wiley-Blackwell, 2009
Degrees
Degrees
BIOMEDICAL SCIENCES
Master’s Degree
2 years
No Results Found
People
People
Ricercatori
No Results Found