Provide the student with 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 drawing and two-stage Simon's drawing; drawings 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

Nothing

In relation to medical statistics for clinical diagnostics and drug testing, the student must show possession: D1 - mastery of basic knowledge; D2 - understanding the fundamental concepts of the discipline; D3 - the ability to use knowledge and concepts to reason according to the logic of the discipline; D4 - ability to communicate results to specialists and non-specialists; D5 - ability to study in depth independently

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

Supplementary seminars

Exercises

Teaching

Didactic methods:  Frontal lessons

Obligations Nobody; but attendance is strongly recommended

Course books

Study texts: Rocchi MBL: Statistics and research methodology for biomedical and psycho-behavioral disciplines, Goliardic Editions, Trieste, 2007

Supplementary material will be provided by the teacher

Assessment

Oral test; the test consists of three open-ended questions, each relating to one of the program topics. During the oral test, it is possible to ask for short and simple numerical examples relating to the topics under discussion.

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

The material available on blended.uniurb.it may be advantageously used

Attendance

As for those attending

Course books

As for those attending

Assessment

As for those attending

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.