Critical Thinking in Clinical Research: Applied Theory and Practice Using Case Studies

ISBN : 9780199324491

Felipe Fregni; Ben M.W. Illigens
536 ページ
156 x 235 mm
  • Based on the successful "Principles and Practice in Clinical Research (PPCR)" course at the T.H. Chan Harvard School of Public Health
  • Shows the key principles behind designing, conducting, and analyzing clinical research
  • Provides insight into critically reading and interepeting current scientific and medical literature

One of the most crucial skills a clinician, scientist, or student can learn is to create, conduct, and interpret the conclusions of a clinical study. Critical Thinking in Clinical Research teaches these fundamentals in four distinct sections, called "units": the first unit focuses on issues surrounding the design of a study such as population, question selection, randomization, and blinding; Unit 2 presents statistical methods such as analyzing data collected, how to present and discuss the data concisely; the third unit covers practical aspects such as methodology, organizational considerations, principles of trial conduct and reporting; and the final unit delves into study designs, providing the advantages and drawbacks of each design style.
Each chapter begins with a short introduction, followed by a hypothetical case that challenges the reader to make decisions, to consider pros and cons of specific approaches, and to evaluate options based on specific conditions. Knowing how to critically read and understand scientific papers and to collect, analyze, and interpret research data, which they in turn can then present in their own scientific manuscript makes this book the perfect resource for anyone looking to contribute to the wealth of scientific and medical inquiry.


Section 1
CHAPTER 1: Basics of Clinical Research: Introduction to Clinical Research
Rui Nakamura, Faiza Khawaja, Laura Castillo, Felipe Fregni, Steven Freedman
CHAPTER 2: Selection of the Research Question
Keiko Ueda and Lotfi B. Merabet
CHAPTER 3: Study Population
Sandra Carvalho and Felipe Fregni
CHAPTER 4: Basic Study Designs
Alexandra Gomez, Felipe Fregni, and Vera Novak
CHAPTER 5: Randomization
Juliana C Ferreira, Ben Illigens, and Felipe Fregni
CHAPTER 6: Blinding
Rita Tomas and Joseph Massaro
CHAPTER 7: Recruitment and Adherence
Timo Siepmann, Ana Isabel Penzlin, and Felipe Fregni

Section 2
CHAPTER 8: Basics of Statistics
Claudia Kimie Suemoto and Catherine Lee
CHAPTER 9: Parametric Statistical Tests
Ben Illigens, Fernanda Lopes, and Felipe Fregni
CHAPTER 10: Non-parametric Statistical Tests
Felipe Fregni and Fernanda Lopes
CHAPTER 11: Sample Size Calculation
Mohammad Azfar Qureshi and Jessica Paulus
CHAPTER 12: Survival Analysis
Jorge Leite and Sandra Carvalho
CHAPTER 13: Other Issues in Statistics I (missing data, intention-to-treat analysis and covariate adjustment)
Tamara Jorquiera and Hang Lee
CHAPTER 14: Other Issues in Statistics II (Subgroup analysis and meta-analysis)
Jorge Leite and Munir Boodhwani

Section 3
CHAPTER 15: Non-Inferiority Design
Raquel Ajub Moyses, Valeriam Angelim, and Scott Evans
CHAPTER 16: Observational Studies
Minou Djannatian and Clarissa Valim
CHAPTER 17: Confounders And Using The Method Of Propensity Scores
Chin Lin
CHAPTER 18: Adaptive Trials and Interim Analysis
Priscila Andrade, Nazem Atassi, and Laura Castillo-Saavedra

Section 4
CHAPTER 19: Integrity in Research: Authorship & Ethics
Sandra Carvalho and Gustavo Rivara
CHAPTER 20: The Business of Clinical Research
Livia Caroline, Mariano Compte, and Jorge Leite
CHAPTER 21: Design and Analysis of Surveys
Ana R. Martinez and Ines C.R. Henriques
CHAPTER 22: Assessing Risk and Adverse Events
Laura Castillo-Saavedra, Suely Matsubayashi, Faiza Khawaja, John Ferguson, and Felipe Fregni
CHAPTER 23: Manuscript Submission
Alma Tamara Sanchez Jimenez and Felipe Fregni


Felipe Fregni, MD, PhD, MPH, is the Director of the Laboratory of Neuromodulation at Spaulding Rehabilitation Hospitalas well as an Associate Professor of Neurology and Physical Medicine and Rehabilitation at Harvard Medical School. He is also the course director for the HMS continuing medical education course, Principles and Practice of Clinical Research, a 6-month distance learning course. It focuses on promoting collaboration and bringing clinical research education to practicing clinicians worldwide.
Ben M.W. Illigens, MD, PhD is an instructor of neurology at the Beth Israel Deaconess Medical Center and the Harvard Medical School. Along with Dr. Felipe Fregni, Dr. Illigens teaches the Principles and Practice of Clinical Research, which inspired this book.

Priscila Caldeira Andrade, PharmD, MPH
Health Economics & Market Access Manager-Northern Region (Latin America) 
Johnson & Johnson Medical
Harvard School of Public Health

Nazem Atassi, MD
Department of Neurology
Harvard Medical School
Massachusetts General Hospital
Boston, MA

Munir Boodhwani, BSc, MD
University of Ottawa Heart Institute
Ottowa, Canada

Livia Caroline Barbosa Mariano, MD
Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil

Sandra Carvalho, MSc, PhD
Neuromodulation Center
Spaulding Rehabilitation Hospital
Harvard Medical School
Boston, MA

Laura Castillo-Saavedra, MD
University of Chicago Medicine 
The Pritzker School of Medicine
Chicago, IL

Minou Djannatian, MD
Department of Neuroscience, Molecular Biology, Cell Biology
Technische Universitat Munchen 
Munich, Germany

Scott Evans, PhD
Director of the Statistical and Data Management Center (SDMC), Antibacterial Resistance Leadership Group (ARLG)
Department of Biostatistics
Harvard University School of Public Health
Boston, MA

Juliana C. Ferreira, PhD
Respiratory Intensive Care Unit 
Hospital das Clinicas Medical School, USP
Sao Paulo, Brazil

Steven D. Freedman, MD, PhD
Chief, Division of Translational Research
Department of Medicine
Beth Israel Deaconess Medical Center
Boston, MA

Felipe Fregni, MD, PhD, MMSc, MPH
Director, Spaulding Neuromodulation Center
Director, Collaborative Learning in Clinical Research Program, Principles and Practice of Clinical Research
Departments of Physical Medicine & Rehabilitation, Neurology, and Continuing Education
Harvard Medical School
Boston, MA

Ines C.R. Henriques, MD
Faculty of Medicine of the University of Coimbra
Coimbra, Portugal

Ben M.W. Illigens, MD
Department of Neurology
Beth Israel Deaconess Medical Center
Harvard School of Medicine
Boston, MA

Tamara Jorquiera, MD, MSc
Department of Medicine
University of San Martin de Porres
Lima, Peru

Faiza Khawaja, MD
Department of Clinical Pharmacology and Internal Medicine
The Michener Institute for Applied Health Sciences
Toronto, Canada

Catherine Lee, PhD
Department of Biostatistics
Harvard T. H. Chan School of Public Health
Boston, MA

Hang Lee, PhD
Department of Medicine
Massachusetts General Hospital
Harvard Medical School
Boston, MA

Jorge Leite, PhD
Laboratory of Neuromodulation
Spaulding Rehabilitation Hospital
Harvard Medical School
Boston, MA

Fernanda Lopes, PhD
Neuromodulation Center
Spaulding Rehabilitation Hospital
Harvard Medical School
Boston, MA

Suely Matsubayashi, PhD
Teaching Assistant Coordinator of PPCR program 
Harvard T.H. Chan School of Public Health
Boston, MA

Lotfi B. Merabet, OD, PhD, MPH
Director, the Laboratory for Visual Neuroplasticity
Department of Ophthalmology
Harvard Medical School
Boston, MA

Raquel Ajub Moyses, MD
Hospital das Clinicas, Faculdade de Medicina FMUSP
Sao Paulo, Brazil

Rui Nakamura, MD
Principles and Practice of Clinical Research
Harvard T.H. Chan School of Public Health
Boston, MA

Vera Novak, PhD, MD
Department of Neurology
Beth Israel Deaconess Medical Center
Harvard School of Medicine
Boston, MA

Jessica Paulus, ScD
Investigator, Institute for Clinical Research and Health Studies
Assistant Professor of Medicine
Tufts University School of Medicine
Medford, MA

Ana Isabel Penzlin, MD
Medica na FKH
Dresden, Germany

Mohammad Azfar Qureshi. MBBS
Department of Nephrology 
King Abdulaziz Medical City, Saudi Arabia

Timo Siepmann, MD
Departments of Neurology, Internal Medicine, Clinical Pharmacology
Universitatsklinikum Dresden
Dresden, Germany

Claudia Kimie Suemoto, MD, PhD
Division of Geriatrics
University of Sao Paulo Medical School
Sao Paulo, Brazil

Keiko Ueda, MD
Principles and Practice of Clinical Research
Harvard School of Medicine
Boston, MA

Clarissa Valim, MD, MSc, ScD
Department of Immunology and Infectious Diseases
Harvard TH Chan School of Public Health
Boston, MA