Pharmacy

The program of the course will examine all aspects related to the various phases of clinical trials, starting with current legislation, methods of designing a clinical study up to the collection of data and analysis of the results. Topics of bioethics and good clinical practice will be addressed and biostatistics topics will be discussed. The course will also include classroom exercises to allow students to apply the knowledge acquired and to exercise a critical sense in relation to the problems studied. Clinical trials History Bioethics The placebo Informed consent Non-profit clinical trials The independence of research Clinical trials in the regulatory and institutional framework of the SSN The main normative sources and the general institutes Regulatory aspects, regulatory authorities and approval processes The protection of privacy The discipline of consent Committees of bioethics History National and international regulatory references Role and functions of the Bioethics Committees The composition The phases of pharmacological experimentation Notes on the phases of preclinical research The phases of clinical research The structure of a clinical study Definition of screening, baseline, treatment and post-treatment periods The uncontrolled experimentation The non-randomized controlled trial The controlled and randomized trial The meta-analysis The bias in the clinical trial Fundamental criteria for a correct clinical trial on drugs: Control group Randomization Blindness Inclusion and exclusion criteria Good clinical practice The assumptions and the first US guidelines The European guidelines Project Management Management of a clinical trial

In order to understand and study the topics that will be the subject of the course, and to achieve the learning objectives envisaged by the teaching, knowledge of basic subjects, such as human physiology and human anatomy, is essential. Knowledge of general and special pharmacology and general pathology is strongly recommended.

Class notes Shamley D. Ed C., Wright B. A Comprehensive and practical guide to clinical trials. Academic Press; 1st edition (11 June 2017). ISBN-10: 0128047291; ISBN-13: 978-0128047293 Articles, ad hoc reviews selected by the teacher

Class attendance is recommended to allow the student not only to acquire specific knowledge concerning the subject of the course, but also to develop communication skills and technical language through interaction with the teacher. Furthermore, the student will be stimulated to formulate judgments and critical sense regarding the topics studied in the class.

The final exam consists of an oral test during which the knowledge acquired by the student regarding the topics covered by the exam program and addressed during the lessons will be assessed. In addition to the specific preparation of the student on exam topics, the reasoning ability and the ability to communicate with an appropriate technical language are also evaluated. The duration of the exam essentially depends on the presentation skills of the student. An average duration of about 20 minutes is conceivable. The course does not include intermediate tests but a final exam at the end of the course. The final exam days have pre-established dates and are published on the e-learning and Infostud platforms. Both teachers are available to add extraordinary dates for the final exam on the basis of the students’ requests. To pass the exam it is necessary to achieve a grade of at least 18/30 which corresponds to a sufficient preparation on all the topics of the course. Grades will be divided as follows: 18 = sufficient knowledge; 19-23 = fair knowledge; 24-27 = good knowledge; 28-30 = excellent knowledge; 30 with laude = outstanding knowledge.

Lectures, PowerPoint presentation and guided exercises in the classroom. The teaching method mainly includes lectures that involve the use of power point, databases (e.g. PubMed) and projections of short movies related to pharmacological issues that can stimulate the critical sense. All these tools will be used to promote interactive discussions in the classroom. The lectures will deal with the topics included in the program, focusing in particular on the topics that are more difficult for the student to understand and suggesting links between the various topics of the program.

The program of the course will examine all aspects related to the various phases of clinical trials, starting with current legislation, methods of designing a clinical study up to the collection of data and analysis of the results. Topics of bioethics and good clinical practice will be addressed and biostatistics topics will be discussed. The course will also include classroom exercises to allow students to apply the knowledge acquired and to exercise a critical sense in relation to the problems studied. Clinical trials History Bioethics The placebo Informed consent Non-profit clinical trials The independence of research Clinical trials in the regulatory and institutional framework of the SSN The main normative sources and the general institutes Regulatory aspects, regulatory authorities and approval processes The protection of privacy The discipline of consent Committees of bioethics History National and international regulatory references Role and functions of the Bioethics Committees The composition The phases of pharmacological experimentation Notes on the phases of preclinical research The phases of clinical research The structure of a clinical study Definition of screening, baseline, treatment and post-treatment periods The uncontrolled experimentation The non-randomized controlled trial The controlled and randomized trial The meta-analysis The bias in the clinical trial Fundamental criteria for a correct clinical trial on drugs: Control group Randomization Blindness Inclusion and exclusion criteria Good clinical practice The assumptions and the first US guidelines The European guidelines Project Management Management of a clinical trial

In order to understand and study the topics that will be the subject of the course, and to achieve the learning objectives envisaged by the teaching, knowledge of basic subjects, such as human physiology and human anatomy, is essential. Knowledge of general and special pharmacology and general pathology is strongly recommended.

Class notes Shamley D. Ed C., Wright B. A Comprehensive and practical guide to clinical trials. Academic Press; 1st edition (11 June 2017). ISBN-10: 0128047291; ISBN-13: 978-0128047293 Articles, ad hoc reviews selected by the teacher

Class attendance is mandatory to allow the student not only to acquire specific knowledge concerning the subject of the course, but also to develop communication skills and technical language through interaction with the teacher. Furthermore, the student will be stimulated to formulate judgments and critical sense regarding the topics studied in the class.

The final exam consists of an oral test during which the knowledge acquired by the student regarding the topics covered by the exam program and addressed during the lessons will be assessed. In addition to the specific preparation of the student on exam topics, the reasoning ability and the ability to communicate with an appropriate technical language are also evaluated. The duration of the exam essentially depends on the presentation skills of the student. An average duration of about 20 minutes is conceivable. The course does not include intermediate tests but a final exam at the end of the course. The final exam days have pre-established dates and are published on the e-learning and Infostud platforms. Both teachers are available to add extraordinary dates for the final exam on the basis of the students’ requests. To pass the exam it is necessary to achieve a grade of at least 18/30 which corresponds to a sufficient preparation on all the topics of the course. Grades will be divided as follows: 18 = sufficient knowledge; 19-23 = fair knowledge; 24-27 = good knowledge; 28-30 = excellent knowledge; 30 with laude = outstanding knowledge.

Lectures, PowerPoint presentation and guided exercises in the classroom. The teaching method mainly includes lectures that involve the use of power point, databases (e.g. PubMed) and projections of short movies related to pharmacological issues that can stimulate the critical sense. All these tools will be used to promote interactive discussions in the classroom. The lectures will deal with the topics included in the program, focusing in particular on the topics that are more difficult for the student to understand and suggesting links between the various topics of the program that can help the student to tackle the study even independently.