Early Phase Clinical Trials in Oncology and Hemato-Oncology: from Preclinical Research to Study Design and Management

Master
2nd level vocational master
A.Y. 2024/2025
Study area
Medicine and Healthcare
2nd level vocational master
60
ECTS
1
Years
15-03-2025 - 20-03-2026
Italian
Master Coordinator
This vocational master programme is designed to meet the increasing need for professionals capable of managing early phase oncology clinical trials. The goal is to provide students with a deep knowledge of methods and practices used in preclinical drug research and in the design of phase I clinical trials, with a particular focus on the following aspects: determination of the initial dose; dose-escalation designs; patient safety management; clinical trial management; pharmacovigilance legislation; clinical research ethics; data analysis and interpretation. The programme will help students develop a multidisciplinary approach to the management of clinical trials, facilitating networking and collaborations with oncologists, pharmacologists, study coordinators, research nurses and other professionals involved. Students will have the opportunity to apply theoretical knowledge to real situations by participating in practical sessions, case studies and workshops, so as to improve their operational and decision-making skills.
To be eligible for the programme, applicants must hold a Master's degree or a single-cycle Master's degree in one of the following classes pursuant to Ministerial Decree 270/2004: LM-6 Biology, LM-8 Industrial Biotechnologies, LM-9 Pharmaceutical, Veterinary and Medical Biotechnologies, LM-13 Pharmacy and Industrial Pharmacy, LM-41 Medicine, LM-54 Chemistry, LM-51 Psychology.
The programme aims to train future professionals who will be able to work in a number of roles and settings. Within pharmaceutical companies, for example, they could take on the management and coordination of early phase clinical trials, or work as preclinical and clinical drug developers, bio-analytics and pharmacokinetics specialists, risk management and preclinical safety experts or pharmacovigilance and drug safety managers. Alternatively, they could be employed as Clinical Research Associates (CRA), also known as Clinical Monitors, or as project managers and study coordinators within phase I trials by Contract Research Organisations (CRO), or as clinical research laboratory managers by hospitals and medical centres. Within regulatory agencies, they could work as experts in the evaluation of clinical study protocols, ethics and compliance specialists, quality and regulatory managers, or clinical compliance consultants. Lastly, they could work for biomedical start-ups as innovation project leaders, preclinical drug developers and early phase specialists, fundraising managers and research project managers.

Courses list

Open sessions
Courses or activities Professor(s) ECTS Total hours Language
Compulsory
A Comparison of Leading Institutions in Conducting Phase I Trials: Innovations and Results 3 24 Italian
Advanced Therapies in Phase I Clinical Trials 2 13 Italian
Biomarkers in Phase I Trials 2 18 Italian
Data Analysis and Interpretation
3 30 Italian
Design and Conduct of Phase I Clinical Trials 4 36 Italian
Drug Evaluation in Phase I Trials: Practical Exercises
2 24 Italian
Final Examination
Italian
Integrating the Patient Perspective in Phase I Trials 2 15 Italian
New Frontiers in the Applications of Monoclonal Antibodies in Cancer Therapy 2 17 Italian
New Therapeutic Approaches and Drugs in Development for Hematologic Tumors 2 18 Italian
New Therapeutic Approaches and Drugs in Development for Solid Tumors 3 24 Italian
Phase I Clinical Trials in Pediatrics
3 21 Italian
Practical Applications of Risk Assessment in Phase I Trials
3 53 Italian
Preclinical Research 10 100 Italian
Regulatory and Legislative Aspects 4 38 Italian
Safety Management and Assessment 1 10 Italian
Study Days On Phase I Clinical Trials
2 24 Italian
Technology and Innovation in Phase I Trials 4 35 Italian
Training Internship
8 200 Italian

Enrolment

Places available: 25

Call for applications

Please refer to the call for admission test dates and contents, and how to register.

Application for admission: from 17/12/2024 to 03/02/2025

Application for matriculation: from 25/02/2025 to 04/03/2025

Read the Call


Please note

Deadline for call: 3 of february 2025. Is only available the call for applicantions' italian version uploaded in this page.