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 | Office hours for students | |
|---|---|---|
| Davide Sisti | For receipt, send an email for an appointment |
| Teaching in foreign languages |
|---|
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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
| Date | Time | Classroom / Location |
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| Date | Time | Classroom / Location |
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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
Bridging Courses
Nothing
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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