Syllabus del corso
Obiettivi
Statistical Aspects
To understand the different types of studies in clinical research: a translational approach from pre-clinical to clinical research.
Research Ethics
To provide students with an overview of the main ethical and legal issues related to scientific research, access to data and data sharing. The Research Ethics course is designed in a highly innovative manner, with the goal of fostering an ethical attitude in the relationship with the patients and/or the lab animals (research ethics and animal ethics) and with the colleagues (research integrity).
Regulatory Aspects
Introduction to the key features relating to the regulatory legislation and the Good Clinical Practices (GCP) principles.
Contenuti sintetici
Statistical Aspects
Design of RCTs – 6h Maria Grazia Valsecchi
Early phase study design – 4h Stefania Galimberti
Biomarker based designs – 4h Andrea Callegaro
Multiple testing – 2h Aldo Solari
Sample Size Calculation – 2h Davide Bernasconi
Adaptive designs – 4h Federico Rotolo
Estimands – 2h Stefano Vezzoli
Bayesian designs – 4h Paola Berchialla
Study PASS (Post Authorization Safety Study) and PAES (Post Authorization Efficacy Study) – 4h Domenico Criscuolo
Research Ethics
Fundamental ethics principles in research; Data governance and regulatory landscape (GDPR); issues and models related to data access / data sharing – 2h Luca Marelli
The Ethics and Law of Experiments on Animals; End of life issues and the rights of terminally ill patients – 2h Silvia Salardi
The role of Ethical Committees – 2h Maddalena Lettino
Regulatory Aspects
Regulatory aspects & legislations: the view of AIFA – 2h Sandra Petraglia
Regulatory aspects & legislations: the view of pharma – 2h Maria Elena Trovati
Regulatory aspects & legislations in the area of rare-diseases – 2h Annabella Amatulli
Good clinical practices – 2h Silvia Mori
Periodo di erogazione dell'insegnamento
Statistical Aspects
June 21st 17.00-19.00 Maria Grazia Valsecchi - PRE-RECORDED VIDEO
June 22nd 9.00-13.00 Maria Grazia Valsecchi - PRE-RECORDED VIDEO
June 26th 17.00-19.00 Andrea Callegaro - STREAMING
June 28th 17.00-19.00 Andrea Callegaro - STREAMING
June 29th 9.00-13.00 Stefania Galimberti - PRE-RECORDED VIDEO
July 1st 17.00-19.00 Aldo Solari - STREAMING
July 3rd 17.00-19.00 Davide Bernasconi - PRE-RECORDED VIDEO
July 5th 17.00-19.00 Stefano Vezzoli - STREAMING
July 6th 9.00-13.00 Federico Rotolo - PRE-RECORDED VIDEO
July 10th 17.00-19.00 Paola Berchialla - PRE-RECORDED VIDEO
July 12th 17.00-19.00 Paola Berchialla - PRE-RECORDED VIDEO
July 13th 9.00-13.00 Domenico Criscuolo - STREAMING
Research Ethics
July 15th 17.00-19.00 Luca Marelli
July 17th 17.00-19.00 Silvia Salardi - STREAMING
July 19th 17.00-19.00 Maddalena Lettino - STREAMING
Regulatory Aspects
July 22nd 17.00-19.00 Sandra Petraglia - STREAMING
July 24th 17.00-19.00 Silvia Mori - STREAMING
July 26th 17.00-19.00 Maria Elena Trovati - STREAMING
July 27th 10.00-12.00 Annabella Amatulli - STREAMING
Modalità di verifica del profitto e valutazione
Individual assignment - Multiple choice questions
Aims
Statistical Aspects
To understand the different types of studies in clinical research: a translational approach from pre-clinical to clinical research.
Research Ethics
To provide students with an overview of the main ethical and legal issues related to scientific research, access to data and data sharing. The Research Ethics course is designed in a highly innovative manner, with the goal of fostering an ethical attitude in the relationship with the patients and/or the lab animals (research ethics and animal ethics) and with the colleagues (research integrity).
Regulatory Aspects
Introduction to the key features relating to the regulatory legislation and the Good Clinical Practices (GCP) principles.
Contents
Statistical Aspects
Design of RCTs – 6h Maria Grazia Valsecchi
Early phase study design – 4h Stefania Galimberti
Biomarker based designs – 4h Andrea Callegaro
Multiple testing – 2h Aldo Solari
Sample Size Calculation – 2h Davide Bernasconi
Adaptive designs – 4h Federico Rotolo
Estimands – 2h Stefano Vezzoli
Bayesian designs – 4h Paola Berchialla
Study PASS (Post Authorization Safety Study) and PAES (Post Authorization Efficacy Study) – 4h Domenico Criscuolo
Research Ethics
Fundamental ethics principles in research; Data governance and regulatory landscape (GDPR); issues and models related to data access / data sharing – 2h Luca Marelli
The Ethics and Law of Experiments on Animals; End of life issues and the rights of terminally ill patients – 2h Silvia Salardi
The role of Ethical Committees – 2h Maddalena Lettino
Regulatory Aspects
Regulatory aspects & legislations: the view of AIFA – 2h Sandra Petraglia
Regulatory aspects & legislations: the view of pharma – 2h Maria Elena Trovati
Regulatory aspects & legislations in the area of rare-diseases – 2h Annabella Amatulli
Good clinical practices – 2h Silvia Mori
Semester
Statistical Aspects
June 21st 17.00-19.00 Maria Grazia Valsecchi - PRE-RECORDED VIDEO
June 22nd 9.00-13.00 Maria Grazia Valsecchi - PRE-RECORDED VIDEO
June 26th 17.00-19.00 Andrea Callegaro - STREAMING
June 28th 17.00-19.00 Andrea Callegaro - STREAMING
June 29th 9.00-13.00 Stefania Galimberti - PRE-RECORDED VIDEO
July 1st 17.00-19.00 Aldo Solari - STREAMING
July 3rd 17.00-19.00 Davide Bernasconi - PRE-RECORDED VIDEO
July 5th 17.00-19.00 Stefano Vezzoli - STREAMING
July 6th 9.00-13.00 Federico Rotolo - PRE-RECORDED VIDEO
July 10th 17.00-19.00 Paola Berchialla - PRE-RECORDED VIDEO
July 12th 17.00-19.00 Paola Berchialla - PRE-RECORDED VIDEO
July 13th 9.00-13.00 Domenico Criscuolo - STREAMING
Research Ethics
July 15th 17.00-19.00 Luca Marelli
July 17th 17.00-19.00 Silvia Salardi - STREAMING
July 19th 17.00-19.00 Maddalena Lettino - STREAMING
Regulatory Aspects
July 22nd 17.00-19.00 Sandra Petraglia - STREAMING
July 24th 17.00-19.00 Silvia Mori - STREAMING
July 26th 17.00-19.00 Maria Elena Trovati - STREAMING
July 27th 10.00-12.00 Annabella Amatulli - STREAMING
Assessment method
Individual assignment - Multiple choice questions