Statistical Methods for Clinical Trials

Code:

MI004

Acronym:

MI004

Keywords
Classification	Keyword
OFICIAL	Medicine

Instance: 2014/2015 - SP

Active?	No
Responsible unit:	Department of Health Information and Decision Sciences Department
Course/CS Responsible:	Integrated Master in Medicine

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MIMED	0	Mestrado Integrado em Medicina 2007	6	-	1,5	32	40,5
		Mestrado Integrado em Medicina- Plano oficial 2013 (Reforma Curricular)	6	-	1,5	32	40,5

Teaching language

Portuguese

Objectives

Clinical trials are experimental studies used to evaluate efficacy and safety of therapeutic interventions and technologies in clinical and health service research.  The objective of this course is to cover the basics regarding the design and planning of clinical trials and the statistical methods used in the design, analysis and interpretation of these studies.

Learning outcomes and competences

After this course the students should be able to understand the methodological aspects of clinical trials; to be able to use and execute basic methods of statistical analysis in this context and critically appraise reports of clinical trials.

Working method

Presencial

Program

Selection and recruitment of participants; sample size calculation and power of statistical hypothesis testing; randomization methods; placebo effect and other non-specific effects; blinding; non-compliance and losses of follow-up; choice of outcomes and endpoints; data analysis; structure and presentation of protocols of clinical trials; monitoring of clinical trials.

Mandatory literature

Lawrence M. Friedman; Curt D. Furberg; David L. DeMets; Fundamentals of Clinical Trials, Springer, 1999

Complementary Bibliography

Piantadosi S. ; Clinical Trials: A Methodologic Perspective, John Wiley & Sons, 2005
Meinert CL; Clinical Trials: Design, Conduct, and Analysis – 2nd edition, Oxford University Press, 2012

Teaching methods and learning activities

The course will have a total duration of 15 hours, including 5 hours of theoretical classes and 10 hours of practical classes, during 1 curricular week.

An e-learning platform will be used to support theoretical and practical classes.

keywords

Physical sciences > Mathematics > Statistics > Medical statistics

Evaluation Type

Distributed evaluation with final exam

Assessment Components

Designation	Weight (%)
Exame	70,00
Trabalho escrito	30,00
Total:	100,00

Calculation formula of final grade

Course evaluation will be based on a practical work and a final theoretical exam, with a weighting of 30% and 70% of the final grade, respectively. The final theoretical exam will cover the theoretical content of the course and will include: (a) closed choice questions, simple and multiple and (b) open questions with short and long answers. The final exam will have a duration of 90 minutes.

Examinations or Special Assignments

There is no special assignments.

Special assessment (TE, DA, ...)

In accordance with the rules approved by FMUP.

Classification improvement

In accordance with the rules approved by FMUP.