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ADE - DESIGN AND ANALYSIS OF CLINICAL TRIALS
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ADE - DESIGN AND ANALYSIS OF CLINICAL TRIALS
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Academic year 2020/2021
- Course ID
- SCB0383
- Teaching staff
- Prof.ssa Federica Vigna-Taglianti (Lecturer)
Paola Berchialla (Lecturer) - Year
- 4th year 5th year 6th year
- Teaching period
- Second semester
- Type
- Elective
- Credits/Recognition
- 1
- Course disciplinary sector (SSD)
- MED/01 - statistica medica
MED/42 - igiene generale e applicata - Delivery
- Lecture
- Language
- English
- Attendance
- Mandatory
- Type of examination
- Written
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Sommario del corso
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Course objectives
The course will illustrate the methods for conducting clinical trials, by integrating procedures for designing, analysing and evaluating clinical trials. Special attention will be paid to the design and the randomization process, procedures for enrolment, patient consent, Ethical Committee role, strategies of statistical analysis, interpretation of results.
- To discuss the role of the Ethical Committee
- To describe the basic study designs and the randomization strategies
- To assess the quality of an RCT
- To understand the essential statistical concepts required for performing the sample size calculation
- To understand the statistical methods for data analysis
- To calculate and interpret efficacy measures: RE, RNE, RR, RRR, ARR, NNT
- To draw conclusions about the results of the study and the consequences for the clinical practice
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Results of learning outcomes
Knowledge and understanding
- knowledge and understanding of English language;
- knowledge of methods to conduct a research study;
- knowledge and understanding of risk and impact measures;
- knowledge of methods to evaluate the quality of a scientific study;
- knowledge of guidelines for reporting results;
- knowledge of scientific and technical language.
Ability to apply knowledge and understanding
- to calculate and interpret risk and impact measures;
- to use and integrate knowledge of different disciplines to interpret results of a research study;
- to use tools for the evaluation of the quality of a study and to interpret the results of the evaluation;
- to compute sample size for basic designs;
- to draft the statistical analysis of an RCT;
- to interpret the results of scientific studies and to take decisions for clinical practice;
- to synthesise results of research using scientific language.
Judgment autonomy
- to take decisions for clinical practice based on results of scientific research;
- to evaluate the quality and the reliability of results of a clinical trial;
Ability to communicate
- to describe scientific data;
- to use the scientific and technical language;
- to discuss the results of a scientific report.
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Course delivery
- Lectures
- Exercises
- Analysis of scientific papers
- Small groups work
- Discussion and brainstorming
- Homework
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Learning assessment methods
The assesment will include a homework with the application of the evaluation checklist to a published clinical trial. The student will have to perform the critical evaluation of the methods used in the trial, filling a specific sheet.
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Program
- methods for conducting clinical trials
- study protocol and trial registration
- randomization of patients
- sample size calculation
- patients’ enrolment and patient consent
- the role of Ethical Committee
- the efficacy measures: RE, RNE, RR, RRR, ARR, NNT
- the strategies of statistical analysis
- methods for evaluating the quality of a clinical trial
Suggested readings and bibliography
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- Slides, exercises and publications used in class and provided online
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Note
Maximum number of students: 40
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