MEDICAL STATISTICS FOR CLINICAL DIAGNOSTICS AND CLINICAL DRUG TRIALS mutuato
STATISTICA MEDICA PER LA DIAGNOSTICA CLINICA E LA SPERIMENTAZIONE DI FARMACI
| A.Y. | Credits |
|---|---|
| 2021/2022 | 6 |
| Lecturer | Office hours for students | |
|---|---|---|
| Marco Bruno Luigi Rocchi |
| Teaching in foreign languages |
|---|
|
Course with optional materials in a foreign language
English
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
| Date | Time | Classroom / Location |
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| Date | Time | Classroom / Location |
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Learning Objectives
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.
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 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
Learning Achievements (Dublin Descriptors)
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
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
Seminars; guided exercises
Teaching, Attendance, Course Books and Assessment
- 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
- 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
Material available on blended.uniurb.it can be advantageously used
- Attendance
None
- Course books
As for attending students
- Assessment
As for attending students
- 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.
Notes
The student can request to sit the final exam in English with an alternative bibliography. (Course with optional materials in a foreign language)
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