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

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

• 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.

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.