CLINICAL TRIALS IN PHARMACOLOGY

Degree course: 
Corso di Second cycle degree in BIOMEDICAL SCIENCES
Academyc year when starting the degree: 
2019/2020
Year: 
2
Academyc year when helding the course: 
2020/2021
Course type: 
Supplementary compulsory subjects
Language: 
English
Credits: 
4
Period: 
First Semester
Standard lectures hours: 
32
Detail of lecture’s hours: 
Lesson (32 hours)
Requirements: 

The students should ideally 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 evaluation of students’ proficiency will be based (1) on written exams at the end of the course, and (2) on classroom evaluations during the course.

(1) 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.

(2) Classroom evaluations: at the end of each section of the course (e.g., the section on phase III trials), a scientific article will be read by the professor together with the students (students’ journal club) and a questionnaire, identical to the one used for final exams, will be filled together. A second article will be read in classroom, and students will fill the questionnaire autonomously. These questionnaires will be evaluated; if the evaluation will be positive, students will score a point. This will be repeated 3 times. With this system, students may gain up to 10% of the final score: 3/30 study points. This score will be added to the final score of the students (e.g.: 24+3=27). This system will adequately prepare students for the final exam.

Assessment: 
Voto Finale

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.

The main lecture topics will be:

-Clinical trials: background/introduction
-Outcome measures in clinical trials
-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”)

Allan Hackshaw, A Concise Guide to Clinical Trials. BMJ Books. Wiley-Blackwell, 2009

Convenzionale

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 (student 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.

To make an appointment with the professor: gianpaolo.perletti@uninsubria.it

Professors