Campus life

Main Course
Principles and Practice of Clinical Research

This program covers the basics of clinical research (how to formulate a research question, select study population, randomization and blinding methods) to statistical methods (data distribution and classification, statistical tests, sample size calculation, survival analysis, missing data and meta-analysis); data collection, monitoring and reporting (include training in manuscript writing); and study designs (observational studies, non-inferior and adaptive designs and randomized clinical trials).

What to expect

Our collaborative distance-learning training program in clinical research is offered to participants from Boston and throughout the world. It is designed for individuals who wish to gain basic and advanced training in clinical trials before moving into the field and for those who have experience in this area and aim to broaden their role in the design, management, analysis, and reporting of clinical trials.

 

Learning Objectives: At the end of the program, participants will be able to design clinical trials in an effective manner, collect data appropriately, use the basic functions of a statistical software package, choose appropriate basic statistical tests, run statistical analysis, critically read and understand a research paper, develop clinical research based on integrity principles, discuss the basics of article publication and the reviewing process, and describe more complex clinical trial designs.

Format

This program is a distance-learning program; however, participants have to attend weekly 3-hour interactive video-conference sessions with participants from the same location (for instance, participants from Dresden, Germany meet at University of Dresden for the live connection with Harvard). The videoconference sessions are broadcast from Harvard to different centers across the world (individual participants can also participate via web-conference). Participants are required to participate in forum discussions, read articles and complete assignments and statistical exercises. At the end of the 9-month program, there will be a recommended 5-Day Immersion Course to practice the concepts learned in this program. An optional 3-Day Advanced Statistical Workshop and 2-Day Research Manuscript Writing workshops will also be held in Boston, MA.

 

In order to participate in this distance-learning program, participants will need regular access to a computer with excellent internet connection, email, a PDF viewer, and possibly a webcam and microphone connected to the computer.

Overview

Applicants usually have a graduate degree or a health care professional degree (MD, MPH, biostatistics, epidemiology, nursing, physical and speech therapy, pharmacy, and dentistry) and come from several countries, given that participants can partake in the program remotely in their own city. Although participants can take this program locally, interaction with other students and instructors as well as participation in the program activities is a requirement for the successful completion of the program. On-site participants are required to be present during the videoconference activities.

Program Schedule

This is the 2023 schedule for the 3-hour weekly lectures in the distance-learning

Main Course component of the PPCR program.

BASICS OF CLINICAL RESEARCH

Tutorial Lecture - March 23, 2023 – Program Staff and PPCR Program Director – Felipe Fregni

• Opening remarks
• Syllabus and discussion of the program format
• Team introduction
• Sites introduction
• Using the Collaborative Learning Method: An overview
• Website tutorial
• Discussion

Lecture 1 - April 6, 2023 – Albert Hofman

Introduction to Clinical Trials:

• Overview of clinical research

Lecture 2 - April 13, 2023 – Michele Hacker

Study Population:

• Definition of study population
• Issues on generalization
• Trade-off: Internal validity vs. external generalizability
• Examples from landmark studies

Lecture 3 - April 20, 2023 – David Wypij

Basic Study Design:

• Observational studies
• Randomized control studies
• Nonrandomized concurrent control studies
• Historical controls/databases
• Cross-over designs
• Factorial design
• Studies of equivalence
• Large clinical trials

Lecture 4 - April 27, 2023 – David Wypij

The Randomization Process:

• Fixed allocation randomization
• Simple randomization
• Blocked randomization
• Stratified randomization
• Adaptive randomization procedures (baseline adaptive randomization procedures)
• Mechanisms of randomization

Participating centers

Bangkok, Thailand

Professor Areerat Suputtitada, MD prof.areerat@gmail.com

Basel, Switzerland

Melissa Lee Fen Amrein melissaleefen.amrein@usb.ch

Belo Horizonte, Brazil (Virtu Oftalmologia-BH)

João Neves de Medeiros, MD joaonevesdemedeiros@yahoo.com.br

Belo Horizonte, Brazil (Unimed-BH)

Ana Alice Duarte Maciel universidadecorporativa@unimedbh.com.br

Bogota, Colombia

Karen Hurtado Colorado karen.huco@gmail.com

Boston, MA, USA

Felipe Fregni, MD, PhD, MPH felipe.fregni@ppcr.org

Brasilia, Brazil

Talyta Grippe, MD talytagrippe@gmail.com

Buenos Aires, Argentina – Centro Charles

Patricio Schlottmann schlottp@yahoo.com.ar Izabel Charles clinicacharles@gmail.com

Neuquen, Argentina – CMIC Salud

Dr Juan Manuel Linarez, MD juanmanuel.linares.86@gmail.com

Cali, Colombia (Fundacion Valle del Lili – ICESI)

Jaime Restrepo Tovar jarestrepo@icesi.edu.co

Campinas, Brazil (UNICAMP)

Carolina Lins ppcrunicamp@gmail.com

Canoas, Brazil (La Salle University)

Andressa Souza andressasz@gmail.com

Cascavel, Brazil (Hospital do Câncer de Cascavel – UOPECCAN – PARANA)

Ademar Dantas Cunha Junior, MD ademardcj@gmail.com

Chemnitz, Germany

Prof. Dr. med. habil. Lutz Mirow L.Mirow@skc.de

Chile – Abbott

Dra. Milagro Sosa milagro.sosa@abbott.com

Cuenca, Ecuador, Universidad Catolica de Cuenca Instituto de Neurociencias

Gerardo Beltran Serrano, MD, PhD geralbelser@hotmail.com

Cuenca, Ecuador, Universidad de Cuenca

Dunia Abad, MD dunia.abadc@ucuenca.edu.ec

Ecuador – Abbott

Dra. Cristina Chavez cristinaantonieta.chavez@abbott.com

Curitiba, Brazil

Miguel Morita Fernandes da Silva mim247@mail.harvard.edu

Doha, Qatar

Mohamed Hashim Mahmoud, MD mohamed.hashim@ppcr.org

Dresden, Germany

Timo Sipemann, MD Timo.Siepmann@uniklinikum-dresden.de Ben Illigens, MD illigens@ppcr.org

Guangzhou, China

Dian Zeng vivianzengdian@gmail.com

Guayaquil, Ecuador

Francisco Borja francisco.borja-2019@ppcr.org

Guatemala City, Guatemala

Ing.Jose Francisco Morales Bonilla pmorales@ufm.edu

Huelva, Spain

Carlos Cordero, MD, Msc ccordero.rhb@gmail.com

Lima, Peru(USMP)

Tamara Jorquiera, MD, Msc tjorquieraj@usmp.pe

Lima, Peru(UPeU)

Walter Sixto Murillo Anton cooperacion.lima@upeu.edu.pe

Londrina, Brazil (PUCPR)

Alcindo Cerci Neto, MD alcindo.cerci@gmail.com

Madrid, Spain (Merz Pharma)

Carlos Cordero, MD, Msc ccordero.rhb@gmail.com

Manaus, Brazil

Robson Amorim, MD amorim.robson@gmail.com

Mecca, Saudi Arabia (Al Qura University)

Abdul Haseeb abdul.haseeb@ppcr.org

Mexico City, Mexico

Daniel San Juan, MD pegaso31@yahoo.com Jorge Leon Morales-Quezada, MD lmorales@neuromodulationlab.org

Mexico, Tec de Monterrey

Blanca Bazan-Perkins blanca.perkins@ppcr.org

Montevideo, Uruguay

Luis A. Castillo dr.luiscastillo@gmail.com

Munich, Germany

Danielle Sabina Wendling-Keim, MD Danielle.Wendling@med.uni-muenchen.de

Passo, Fundo – RS,Brazil (CLINICA KOZMA)

Stephan Pinheiro Macedo de Souza, MD pinheiro94ms@gmail.com

Porto, Portugal (Universidade Portucalense Infante D. Henrique)

Jorge Leite jorgel@mail.upt.pt

Porto Alegre, Brazil

Wolnei Caumo, MD wcaumo@hcpa.edu.br

Ribeirao Preto, Brazil

Taiza Edwards – Pontelli, MD taiza@fmrp.usp.br

Rio de Janeiro, Brazil (Instituto D’Or de Pesquisa e Ensino)

Daniella Braz Parente, PhD daniella.parente@gmail.com

Salvador, Brazil

Juleilda Nunes, MD brasiljuli@yahoo.com.br

San Jose, Costa Rica (UCIMED)

Fanny Chan Solano chansf@ucimed.com Sebastian Ospina Henao ospinahs@icimed.cr

Santiago, Chile (CLINICA ALEMANA)

Pablo Lavados, MD and Paula Muñoz Venturelli, MD PhD pmventurelli@gmail.com

Santiago, Chile (CLINICA DAVILA)

José Retamal Carvajal, MD jose.retamal@davila.cl

Santiago, Chile (HOSPITAL DEL TRABAJADOR)

Pablo Carreno Montenegro picarrenom@achs.cl

Santiago, Dominican Republic (PUCMM)

Maria Zunilda Nunez, MD, MSc nunez.zunilda@gmail.com

Santo Domingo, Dominican Republic (CEDIMAT)

Julia Rodriguez, MD jjrodriguez@cedimat.net

Santo Domingo, Dominican Republic (Two Oceans in Health)

Marija Miric, M.A., Ph.D. mmiric@twooceans.health

HAPVIDA, Brazil

Daniela Laranjeira Gomes Rodrigues, MD daniela.laranja@hapvida.com.br

SAESP, Brazil

Maria Carmona, MD and Vanessah Carvalho, MD vanessahcarvalho74@gmail.com

Santos, Brazil

Ana Beatriz Soares, MD abeatriz.soares@gmail.com

Sao Paulo, Brazil – Centro Universitario Sao Camilo

Cristina Camargo consultoriodracristina@gmail.com

Sao Paulo, Brazil (A. C. Camargo Cancer Center)

Felipe José Fernández Coimbra, MD, MsC, PhD. drfelipecoimbra@gmail.com

Sao Paulo, Brazil (HCor Research Institute (IP-HCor))

Alexandre Biasi, MD abiasi@hcor.com.br

Sao Paulo, Brazil (Hospital Sirio-Libanes)

Tiago Lazzaretti, MD tiagot86@hotmail.com

Sao Paulo, Brazil (Instituto D’Or de Pesquisa e Ensino)

Camila Moniz, MD camila_med33@yahoo.com.br

Sao Paulo, Brazil (São Camilo Oncologia)

Felipe Melo Cruz, MD felipemcruz@yahoo.com.br

Sao Paulo, Brazil (Universidade de Sao Paulo)

Linamara Rizzo Battista linamara.battistella@hc.fm.usp.br

Seoul, Korea

Woo Jin Hwang (M.I.I. Asia) hwooj12@gmail.com

Tegucigalpa, Honduras (UNITEC)

Professor Dr Manuel Sierra manuel.sierra@unitec.edu.hn  Professor Dr Juan Pablo Bulnes juan.bulnes@unitec.edu.hn

Tokyo, Japan

Keiko Ueda, MD keikougg@gmail.com

Toronto, Canada

Natascha Silva Sandy, MD natascha.silvasandy@sickkids.ca

Valladolid, Spain

Maria Begoña Coco Martin iobabego@gmail.com