PhD in Complex Systems for Quantitative Biomedicine

How to Write a Clinical Trial

Academic year 2023/2024

Sommario del corso

• Course objectives
• Program
• Course delivery
• Teaching tools
• Course card

Course objectives

Knowledge on the conduction of clinical trials on humans. 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 hospitals or research institutions.
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.

Program

• Types of studies, how a (general) protocol is formulated, people involved in
  drafting, reviewing, accepting and implementing.
• Databases and data quality.
• Randomization of samples.
• Sample size calculation in different cases (using R).

Course delivery

• Lessons: the 5th and the 12th of March, h 14.00-18.00
• Where: Aula B, Anatomia, Corso Massimo D'Azeglio 50
• Type: in presence. If you can, bring your laptop for some exercises during the lesson
  (no specific software will be needed)

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