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Planning and Conducting Biomedical Research – Part 1/2 – AUTUMN 2022 (ENG)

7 Novembre 2022 / 9:00 - 16:30

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 Programmes at the Faculty of Biomedical Sciences at USI, ETH and USZ and it is structured as common course (General skills).

 

Duration: 2 day – 7 and 14 November 2022
Credits: 1 ECTS, ISFM and Swapp
Language: 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

The program may still be subject to changes. Thank you!
CLICK HERE TO OPEN THE PROGRAM IN PDF FORMAT
  • 09h00

    Start course

  • 09h00

    Introduction to the course

  • 09h30

    Preclinical phase, principles of methodology

    • Objectives and pathways
    • What is a preclinical model? In silico, in vitro and in vivo Models in systems biology
    • Preclinical endpoints
  • 10h45

    BREAK

  • 11h00

    Statistical principles for experimental design

    • Methodological issues
    • Designs of preclinical experiments
    • Statistical inference, basic concepts
  • 12h30

    LUNCH

  • 13h30

    Clinical phase, methodology of early development

    • First in human, dose finding studies. Relationships between dose, safety and activity of a compound
  • 15h15

    BREAK

  • 15h30

    Clinical phase, methodology of early development

    • Presentation and discussion of articles of early development studies
  • 16h30

    End course

The program may still be subject to changes. Thank you!
CLICK HERE TO OPEN THE PROGRAM IN PDF FORMAT
  • 09h00

    Start course

  • 09h00

    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
  • 10h45

    BREAK

  • 11h00

    Methodology of translational research

    • Statistical challenges in the analysis of biological data.
    • Multiple comparisons issues
    • high dimensionality
    • Clustering,
    • Resampling methods
  • 12h30

    LUNCH

  • 13h30

    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
  • 15h15

    BREAK

  • 15h30

    Clinical phase, methodology of rare diseases

    • Rare diseases, definition
    • Useful statistical designs for small trials
    • Useful statistics for small trials
  • 16h30

    End course

Università della Svizzera italiana USI
Campus Est – Sector A – Room A1.03

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    Indirizzo postale Privato (per Fatturazione)

    * Tutti i campi sono obbligatori

    The course fee is CHF 400.- for employees of the Ente Ospedaliero Cantonale and its partners and CHF 650.- for external*.

    By the registration deadline, invoices of the tuition fees will be issued by the Central Accounting and Billing Service (SCCF) of EOC.

    Collaborators of the of the Ente Ospedaliero Cantonale who wish to be reimbursed by their department are kindly invited to make an (electronic) request to EOFORM for authorization.

    In case of cancellation announced less than 2 weeks prior the registration deadline, the fee will be fully requested.

    *For PhD students enrolled in one of the PhD Programmes at the Faculty of Biomedical Sciences at USI, ETH and USZ who present a valid student ID card, no tuition fee will be issued. Registration is still required.

    Registration must be received by October 31, 2022.

     

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

    Dettagli

    Data:
    7 Novembre 2022
    Ora:
    9:00 - 16:30
    Categoria Evento:

    Luogo

    Aula A2.08 Campus Universitario USI/SUPSI – Settore A
    Via La Santa 1
    Viganello, CH 6962 Svizzera
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