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How to write a clinical trial
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How to write a clinical trial
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Academic year 2023/2024
- Course ID
- NEU0294B
- Teacher
- Ilaria Stura (Lecturer)
- Year
- 2nd year
- Teaching period
- First semester
- Type
- Related or integrative
- Credits/Recognition
- 2
- Course disciplinary sector (SSD)
- FIS/07 - applied physics (a beni culturali, ambientali, biologia e medicina)
- Delivery
- Formal authority
- Language
- English
- Attendance
- Obligatory
- Type of examination
- Practice test
- Type of learning unit
- modulo
- Modular course
- Clinical trials, from ethics to practice (NEU0294)
- Prerequisites
- During the course, some concepts of Statistics related to the sample size will be taken up again. It is therefore advisable to review these concepts addressed in the first year Data Science - Statistics
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Sommario del corso
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Course objectives
Knowledge on ethics, legislation and the conduct of clinical trials on humans in Italy. Specifically, the objective of the course is to acquire expertise in the technique of drafting a clinical protocol to be submitted to the Ethics Committee of a hospital or research institution. This will allow the student to know both possible job opportunities (CRO, Research Technician in charge of protocols, ...) and the mechanisms for writing and evaluating clinical protocols.
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Results of learning outcomes
At the end of the course, the student will have acquired both technical knowledge and the ability to apply them. In particular:
- technical knowledge: how to structure a protocol; what are the main documents required for the various types of studies (clinical trial, observational study, profit and non-profit); who are the main stakeholders (Principal Investigator, Department Director, Secretariat of the Ethics Committee, CRO, Pharmaceutical Company, Treasury, Data Protector, ...)
- applied skills: knowing how to write a clinical protocol, combining the medical-biological and statistical knowledge learned in previous courses (in particular: DATA SCIENCE, NEUROLOGY/ NEUROPHARMACOLOGY/NEUROSURGERY) with the techniques learned in the course.
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Program
The topics are sometimes in common with the module "How to read a clinical trial". In particular, the last lessons (workshops) will be held by the teachers of both modules.
The program below is about the entire course, while the lessons marked in bold refer to the module "How to write a clinical trial".
Lesson 1: Introduction to Ethical and legal regulations
Lesson 2: Types of study, how a (general) protocol is made, people involved in drafting, reviewing, accepting and implementing.
Lesson 3: Phases of clinical trials: what are the differences?
Lesson 4: The informed consent
Lesson 5-7: Structure of a protocol, with particular emphasis on clinical design (recalls of statistics). Sample size calculation in different cases.
Lesson 8: Additional documents to the protocol. The role of CROs and pharmaceutical companies.
Lesson 9-10: Seminar of speakers who work as study coordinator and/or within the Ethics Committee and/or CRO and/or pharmaceutical companies, in the clinical research field.
Lesson 11-12: Analysis of some real clinical protocols.
Lesson 13-16: group workshop. Each group writes a protocol starting from an outline given by the teachers, then revises the one written by another group. Final discussion in class.
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Course delivery
Class Lessons: multimedia (slides,...)
Seminars by 2/3 speakers (from Ethic Committee and/or backoffice of clinical trial organizers and/or study coordinator).
Work in groups
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Learning assessment methods
Unique exam for both modules. Group work: evaluation of the drafting of the clinical protocol, review of the protocol of others, participation in the final discussion.
Suggested readings and bibliography
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During the lessons, indications will be provided on where to find the reference regulations and suggestions for reading and reflection. There are no mandatory texts
- Enroll
- Open
- Enrollment opening date
- 18/04/2023 at 00:00
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