The course aims to give the student the statistical and methodological knowledge essential in the context of clinical diagnostics and the validation process of new therapies, including through the use of open-source software and spreadsheets.

Part A - Statistics for diagnostics

The evaluation measures of a diagnostic test: Sensitivity, specificity, positive and negative predictive values, LR +, LR-.

The ROC curves: meaning and construction

The optimal threshold of a diagnostic test: Youden approach and economic approach

The validation of a diagnostic test: intraclass correlation coefficient and concordance measures

Part B - Statistics and methodology for the experimentation of therapeutic products

Phase I, II, III, and IV studies.

The experimental design in Phases I, II, III: designs for the choice of the optimal dosage; Fleming's design and two-stage Simon's design; design between patients and within patients (cross-over)

Observational designs for Phase IV studies

The sample size and the power of the design

The techniques of randomization and non-randomized allocation

Treatment effectiveness measures: Absolute Risk Reduction, Relative Risk, Relative Risk Reduction, Odds Ratio, Number to Treat

Introduction to pharmacokinetic modeling for Phase I studies

In relation to statistics for biomedical sciences, students should show possession of: 

D1 - the mastery of basic skills; 

D2 - the understanding of the fundamental concepts of the discipline 

D3 - the ability to use knowledge and concepts to reason according to the logic of the discipline

D4 - the ability to communicate to specialist and non-specialist audiences

D5 - the ability to study in an autonomous manner

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

Seminars; guided exercises 

Teaching

Frontal lessons

Attendance

None; attendance is strongly recommended

Course books

Rocchi MBL: Statistica e metodologia della ricerca per le discipline biomediche e psicocomportamentali, Edizioni Goliardiche, Trieste, 2007 

Other materials will be provided by the teacher

Assessment

Elaboration and oral presentation of a thesis on a topic to be agreed

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

Teaching

Material available on blended.uniurb.it can be advantageously used

Attendance

None

Course books

As for attending students

Assessment

As for attending students

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

The student can request to sit the final exam in English with an alternative bibliography. (Course with optional materials in a foreign language)