Statistical Methods for Clinical Trials

Code:

MI004

Acronym:

MI004

Keywords
Classification	Keyword
OFICIAL	Medicine

Instance: 2016/2017 - 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 the efficacy and safety of new treatments and technologies in clinical and health service research.  The objective of this course unit is to introduce the methodology of clinical trial design, focusing on its statistical design and analysis. 

Learning outcomes and competences

After this course unit the students will be able to understand the methodological aspects of clinical trials and critically assess the published results of clinical trials.

Working method

Presencial

Program

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

Mandatory literature

Friedman, L. M., Furberg, C. D. & DeMets, D. L; Fundamentals of Clinical Trials (4th edition), London: Springer, 2010
Piantadosi, S. ; Clinical Trials: A Methodologic Perspective, New Jersey : John Wiley & Sons, 2005
Meinert, C. L. ; Clinical Trials: Design, Conduct, and Analysis (2nd edition). , New York: Oxford University Press., 2012

Teaching methods and learning activities

The course unit will have a total duration of 14 hours; 9 hours of theoretical classes and 5 hours of theoretical-practical classes. After the presentation of each topic there will be time for group discussion on selected clinical trials, published in the medical literature. An e-learning platform will be used to deliver class notes and to facilitate the communication between students and teaching staff.

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

The final grade will be based on the result of a theoretical exam (14 points) and practical exercise (6 points).