## MEDICAL STATISTICS FOR CLINICAL DIAGNOSTICS AND CLINICAL DRUG TRIALS STATISTICA MEDICA PER LA DIAGNOSTICA CLINICA E LA SPERIMENTAZIONE DI FARMACI

A.Y. Credits
2022/2023 6
Lecturer Email Office hours for students
Davide Sisti For receipt, send an email for an appointment
Teaching in foreign languages
Course with optional materials in a foreign language
This course is entirely taught in Italian. Study materials can be provided in the foreign language and the final exam can be taken in the foreign language.

### Assigned to the Degree Course

Medical Biotechnologies for diagnostics and therapy (LM-9)
Curriculum: BIOTECNOLOGIE PER LA DIAGNOSTICA MOLECOLARE
Date Time Classroom / Location
Date Time Classroom / Location

### Learning Objectives

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.

### Program

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

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### Learning Achievements (Dublin Descriptors)

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

### Teaching Material

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

### Supporting Activities

Supplementary seminars

Exercises

### Teaching, Attendance, Course Books and Assessment

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 exam

Disabilità e DSA

Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.

A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.

### Additional Information for Non-Attending Students

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

Disabilità e DSA

Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.

A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.

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