Instituto de Ortopedia e Traumatologia do Hospital das Clínicas
Faculdade de Medicina da Universidade de São Paulo
Prof. Tarcísio Eloy P. Barros Filho / Prof. Arnaldo Valdir Zumiotti / Prof. Olavo Pires de Camargo

CLINICAL TRIALS COURSE – 2008

Offered by Scholars in Clinical Science Program, Harvard Medical School

Organization: Scholars in Clinical Science Program, Harvard Medical School

Ajay Singh, MD, PhD; Felipe Fregni, MD, MBA; Lauren Dewey-Platt, PhD

Center of Acupuncture IOT, University of Sao Paulo, School of Medicine

Wu Tu Hsing, MD, PhD; Marta Imamura, MD, PhD

Start: March 13th 2008

TARGET: Academics for the health care system, researchers, health care legislators, professionals from pharmaceutical companies.

COURSE OBJECTIVES: Provide theoretical understanding of the design, conduction, analysis and interpretation of randomized controlled trials of health interventions. Develop skills to scrutinize information, critically analyze and carry out research, and to communicate effectively.

Other clinical research courses are offered in Boston by the Scholars of Clinical Science Program from Harvard Medical School www.hms.harvard.edu/gradprograms/scsp/ (45 days: US$ 15,000; 2-year course: US$60,000, with a 26% approval rate for foreign students); Department of Health Policy, Management and Evaluation at University of Toronto http://www.hpme.utoronto.ca/ (one year: CND$14,252.82 to 18,452.82 for international applicants).

DURATION: 7 months (March 13rd to October 26th 2008)

FACULTY MEMBERS: Harvard Medical School, Harvard School of Public Health, Harvard Business School

SCHEDULE: (the course will be in English, without translation)

• Weekly lectures by teleconference:

Every Thursday 6pm to 9pm

Brasilia time zone (GMT-3:00)

U.S. Eastern time 5pm to 8pm.

From March to September/2008

• Live 4-day intensive course:

October 23rd-26th, 2008

Monday to Thursday 8am to 6pm

Classes will be given at Maksoud

Plaza Hotel – São Paulo, Brazil

FEES: Registration fee: US$ 3,500.00
Monthly fee: US$ 500.00 (6 months: March to September/08)

ELIGIBILITY: Health care PhD holder or director of a health care service

NECESSARY DOCUMENTATION:

2 recent photos ID, professional license, PhD diploma, a statement of chief or director of a health service letter

Submit curriculum vitae for approval by e-mail to mpattylima@hcnet.usp.br

In order to receive a certification letter at the end of the course, the student must accomplish:

1. Attendance in at least 5 (out of 6) lectures of each module (total of at least 20 lectures);

2. Full attendance in the 4-day onsite intensive course;

3. score of 80% or more in the final examination to be performed at the end of the 4-day onsite intensive course.

INFORMATIONS:

Centro de Estudos Godoy Moreira

Instituto de Ortopedia e Traumatologia HC/FMUSP

8:00am to 4:00pm by phone: 55-11 3086-4106

fax: 55-11 3086-4105

E-mail: martaimf@gmail.com / wu@fmusp.org.br / mpattylima@hcnet.usp.br

Rua Ovídio Pires de Campos, 333 2º andar

Cerqueira César – São Paulo – SP

CEP 05403-010 BRAZIL

Scholars in Clinical Science Program, Harvard Medical School

Clinical Trials Course

March/2008 – October/2008

Course Syllabus

Course directors:

Ajay Singh, MD, MBA

5 Francis Street 
Boston, MA 02115 - 
Tel: 617-732-5951

Email: asingh@partners.org

Felipe Fregni, MD, PhD

330 Brookline Ave – KS 158 – Boston, MA – Tel: 617-667-5272

Email: ffregni@bidmc.harvard.edu

Executive director:

Lauren Dewey-Platt, PhD

260 Longwood Avenue, Suite 157 - Boston, MA  02115 – tel: 617-432-1387

Email: lauren_deweyplatt@hms.harvard.edu

Course Description

This course is relevant both for those wishing to gain an overall understanding of clinical trials before moving into the field and for those who have general or specialist experience in this area and aim to broaden their role in the design, management, analysis, and reporting of clinical trials.

Course Organization:

This is a video-conference course in which 24 lectures (divided in 4 modules) will be broadcast to students in University of Sao Paulo (Sao Paulo, Brazil). This course is a prerequisite for the intensive, live 4-day course in Brazil (October, 2008). Students will be prepared for lectures that will comprise 1-hour lecture followed by 1-hour period of discussion.

Course Objectives

The course aims to provide participants with a theoretical understanding of the issues involved in the design, conduct, analysis, and interpretation of randomized controlled trials of health interventions. It is suitable for students working in a country like Brazil. Students will be trained to develop skills to scrutinize information, to critically analyze and carry out research, and to communicate effectively.

The course is divided in four modules – each module having 6 lectures each:

Module 1 – Basics of Clinical Research

Will provide students with a solid understanding of the basic issues in the design of clinical trials. Outline the fundamental principles of clinical trials including study population, selection of questions, basic study design, randomization process and blindness.

Module 2 - Basic Statistics

Will introduce the basic statistical methods used in clinical trials. How to select and apply appropriate statistical methods to analyze data from clinical trials and presenting, interpreting, and discussing the analyses clearly and concisely.

Module 3 - Assessment, Data Collection and Reporting

The main features of clinical trials, including methodological and organizational considerations, and the principles of trial conduct and reporting will be discussed. Preparing the protocol for a trial, including data collection forms, logistical and budgetary issues are critical issues when designing a clinical trial.

Module 4 – Study Designs

Will introduce the main study designs used in clinical trials. Advantages and drawbacks of each design will be presented; including also the analytical methods and issues of different study designs.

Text and Required Readings

Required book:

1. Foundations of Clinical Research: Applications to Practice (3rd Edition) (Foundations Of Clinical Research) by Leslie Gross Portney, Mary P. Watkins. Pearson Prentice Hall.

Optional books:

1. Clinical Epidemiology: How to Do Clinical Practice Research (third edition) by R. Brian Haynes, David L Sackett, Gordon H Guyatt, Peter Tugwell. Lippincott Williams & Wilkins.

2. Clinical Epidemiology: The Study of the Outcome of Illness (third edition) by Noel S. Weiss. Oxford University Press.

Additional readings and assignments will be distributed in the course package.

Exams and final project:

Pass-fail grading will be based on exams at the end of each module and a grant application that the student will develop along the course and hand in at the end of the course. A certification letter at the end of the course will be given only to participants with satisfactory attendance and grade.

PROGRAM:

DISTANCE-LEARNING CLINICAL RESEARCH TRAINING

(24 weekly lectures of 2 hours of duration)

Module 1: Basics of Clinical Research
Lecture 1	13 March	Introduction to Clinical Trials	Steven Freedman, MD, PhD
Lecture 2	20 March	Study Population	Ajay Singh, MD, MBA
Lecture 3	27 March	Selection of the Questions	Felipe Fregni, MD, PhD, MMSc, MPH
Lecture 4	3 April	Basic Study Design	David Wypij, PhD
Lecture 5	10 April	The Randomization Process	David Wypij, PhD
Lecture 6	17 April	Blindness	Joe Massaro, PhD
Module 2: Statistics
Lecture 7	24 April	Statistics – Basics	Roger Davis, Sc.D.
Lecture 8	8 May	Statistical Tests	Felipe Fregni, MD, PhD
Lecture 9	15 May	Sample Size	Roger Davis, Sc.D.
Lecture 10	29 May	Survival Analysis	Roger Davis, Sc.D.
Lecture 11	5 June	Other Issues in Data Analysis 1	Felipe Fregni, MD, PhD, MMSc, MPH