Biotechnology for Neuroscience

Clinical trials, from ethics to practice

Clinical trials, from ethics to practice

Academic year 2024/2025

Sommario del corso

• Course objectives
• Results of learning outcomes
• Program
• Course delivery
• Learning assessment methods
• Suggested readings and bibliography
• Teaching Modules
• Teaching tools
• Course card

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.

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.

Program

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.

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

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.

Theory on sample size calculation:

Chow, S.-C., Shao, J., Wang, H., & Lokhnygina, Y. (2017). Sample Size Calculations in Clinical Research (3rd ed.). Chapman and Hall/CRC. https://doi.org/10.1201/9781315183084

How to perform sample size calculation (and many other things) on R:

Grolemund, G., & Wickham, H. (2017). R for Data Science. O’Reilly Media.

Teaching Modules

• How to read a clinical trial (NEU0294A)
• How to write a clinical trial (NEU0294B)

• Teaching material
• Exams and finals
• Class schedule
• Go to Moodle
• Register for the course
• Enrolled students
• Invia email agli studenti registrati
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