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Planning and Conducting Biomedical Research – Part 1/2 – SPRING 2021 (ENG)

10 Maggio 2021 / 9:00 - 17:00

The new course “planning and conducting biomedical research”, which is part of the PhD program, wants to offer a comprehensive discussion of the aims, activities and methodological aspects (including statistical principles and applications) of biomedical research, from the preclinical to the advanced clinical development stage in different pathological entities. The last section deals with the special issues faced by preclinical and clinical researchers working in the field of rare disease. A more detailed description of aims and content can be found in the syllabus.
The course is the first one in this field, and is of interest for researchers, clinical scientists and clinical investigators in the translational field to understand their role and input for a mutual productive interaction.

This course it is offered also as parts of the PhD degree programme of the Faculty of Biomedical Sciences, USI and it is structured as common course (General skills).
Duration 2 day (10 and 17 May 2021) = 1 ECTS

The Planning and conducting Clinical Research course will be held in english.

 

Objectives:
To understand the statistical and methodological concepts to help in planning and implementing preclinical and clinical research and to interpret their findings. The course will include practical examples and case discussion, mainly in the field of oncology and neurosciences relevant for the clinical counterpart of some of the participants.

 

Teachers:
Dr. Valter Torri, Lab. Metodologia per la Ricerca Clinica, Mario Negri Milano
Prof. Cristiana Sessa, IOSI Bellinzona

Participation fee:
EOC employees CHF 400, external CHF 650, Free of fee for PhD students USI Lugano

CLICCA QUI PER APRIRE IL PROGRAMMA IN PDF

  • 9:00

    Introduction to the courses

  • 9:30

    Preclinical phase, principles of methodology

    • Objectives
    • What is a preclinical model? In silico, in vitro and in vivo models
    • Preclinical endpoints
  • 10:45

    Coffee break

  • 11:00

    Statistical principles for experimental design

    • Methodological issues
    • Designs of preclinical experiments
    • Statistical inference, basic concepts
  • 12:30

    LUNCH

  • 14:00

    Clinical phase, methodology of early development

    • First in human, dose finding studies. Relationships between dose, safety and activity of an experimental compound
  • 15:45

    Coffee break

  • 16:00

    Clinical phase, methodology of early development

    • Presentation and discussion of articles of early development study in cancer, cardiovascular and neuroscience diseases

CLICCA QUI PER APRIRE IL PROGRAMMA IN PDF

  • 9:00

    Clinical phase, methodology of middle development

    • Objectives and endpoints in phase II studies
    • Review of actual and future biomarkers for phase II trials
    • Discussion and examples
  • 10:45

    Coffee break

  • 11:00

    Methodology of translational research

    • Statistical challenges in the analysis of biological data
    • Multiple comparisons issues
    • High-dimensional analysis
    • Clustering
    • Resampling methods
  • 12:30

    LUNCH

  • 14:00

    Clinical phase, methodology of advanced development

    • Phase III trials
    • Clinical endpoints, choosing the right summary adaptive designs, statistical monitoring
    • Surrogate endpoints
    • Statistical methods for multiple endpoints, switch of treatments
  • 15:45

    Coffee break

  • 16:00

    Clinical phase, methodology of rare diseases

    • Rare diseases, definition
    • Useful statistical designs for small trials

Planning and Conducting Clinical Research

10 May 2021A2.08 Campus Est USI
17 May 2021A2.08 Campus Est USI

    Cognome

    Nome

    Professione e Luogo

    Email

    Indirizzo postale Privato (per Fatturazione)

    * Tutti i campi sono obbligatori

    The course fee is CHF 400.- EOC employees and CHF 650.- for external. Free for PhD students Faculty of Biomedical Sciences USI, ETH, USZ.
    After your registration you will receive an invoice.

    EOC employees who wish to be reimbursed from their service are kindly requested to apply (electronically) to EOFORM for authorization to participate.

    The fee, in case of cancellation announced less than 2 weeks before, must be fully payed.

    For PhD students registered in one of the PhD Programmes at the Faculty of Biomedical Sciences at USI, ETH and USZ, presenting a valid student card, there is no tuition fee to be covered.


    For more information:
    clinicaltrialunit@eoc.ch
    Laura Di Petto 091 811 7944

    Dettagli

    Data:
    10 Maggio 2021
    Ora:
    9:00 - 17:00
    Categoria Evento:

    Luogo

    Aula A2.08 Campus Est – USI Lugano
    Via la Santa 1
    Viganello, CH 6962 Svizzera