The Practical Guide to Clinical Research and Publication

By Uzung Yoon

The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It is ideal for physicians and clinical researchers who want to use it as guidance for clinical research or teaching.

• Contains numerous, clinically-oriented examples and drawings
• Provides an explanation of epidemiology and statistics to aid understanding of clinical research
• Written by a physician with extensive knowledge in research

• Language: English
• Publisher: Academic Press
• Release date: Aug 3, 2021
• ISBN: 9780128245187

Uzung Yoon

Dr. Yoon (MD, MPH) graduated from Hannover Medical School in Germany. During that time he conducted 5 years of laboratory and clinical research and graduated with a MD/PHD equivalent degree. Additionally, he finished a 1 year public health master at Berlin School of Public Health. He wrote a book in German” Von der wissenschaftlichen Fragestellung zur Publikation“ published with Elsevier Germany in 2014. Currently he is a faculty member for Anesthesiology at Thomas Jefferson University Hospital in Philadelphia and continues to conduct and lead clinical research.

Book preview

Chapter 1

Introduction

Abstract

Clinical research is the study of health and disease in human subjects that directly impacts the patient’s health outcome. It uses clinical trials and epidemiological methods to synthesize evidence, to evaluate preventive, therapeutic and diagnostic measurers and to treat illnesses. Clinical research describes many different elements of scientific investigation and helps to translate basic research into clinically relevant information to ultimately improve patient care. In order to interpret the data, and critically assess these clinical trials, one must possess an understanding of the basic principles in conducting a clinical trials, epidemiology, and statistics. This is important in order to understand the fundaments in clinical research for advancing medical knowledge and ultimately improving patient care, whether it being a physician, researcher, or data scientist.

Keywords

Clinical research; clinical trials; epidemiology; statistics

Chapter outline

Outline

Clinical research in medicine 1

Endnote 2

Clinical research in medicine

In medicine, basic research or basic science involves research and laboratory studies that provide the foundation for clinical research. Research increases our understanding of normal human biology and diseases, and ultimately helps us to discover and develop new treatments or technologies to improve health. About 60% of the NIH budget is allocated for basic research, and most of the basic research funds go to PhD scientists.

Translational research is the process of applying discoveries generated during laboratory research and in preclinical studies to the development of trials and studies in humans. Translational research is specifically designed to transfer findings from laboratory and preclinical research to practice settings and communities, where the findings can improve health outcomes.

Clinical research is the study of health and disease in human subjects (or materials of human origin, such as tissues, specimens, and cognitive phenomena) that directly impacts the patient’s health outcome. It uses clinical trials and epidemiological methods to synthesize evidence, to evaluate preventive, therapeutic and diagnostic measurers and to treat illnesses. It is also used in order to study and test new medical equipment, medical procedures, and diagnostic tests. Clinical research describes many different elements of scientific investigation and helps to translate basic research into clinically relevant information to ultimately improve patient care.

The main components of clinical research are epidemiology, statistics, and clinical trials. Epidemiology is the study (scientific, systematic, and data-driven) of the distribution (frequency, pattern) and determinants (causes, risk factors) of health-related states and events (not just diseases) in specified populations (neighborhood, school, city, state, country, global).i It is a fundament of medical science and it helps to understand the principles of the methodology in clinical research. Modern epidemiology heavily emphasizes statistics, computer science, genetics, genomics, and bioinformatics. The role of clinical epidemiology is, by way of clinical research, to provide clinicians with the information to make decisions that are most appropriate in the best interest of their patients. The information is derived from scientific, evidence-based clinical research and systematic, data-driven analysis.

Statistics refers to both quantitative data, and the classification of such data in accordance with probability theory and the application to them of methods such as hypothesis testing. Medical statistics include both empirical data and estimates related to health, such as mortality, morbidity, risk factors, health service coverage, and health systems.

Clinical trials are experiments or observations done in clinical research. Such research studies on human participants are designed to answer specific questions about biomedical or procedural interventions, including new treatments (such as vaccines, drugs, surgical procedures, and medical devices) and known interventions that warrant further study and comparison. Depending on the product type and development stage, clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. The number of new pharmaceuticals, biologics, medical devices, and healthcare services are rapidly expanding and so are clinical trials. The data generated from clinical trials is used to calculate survival information, therapeutic success rates, safety, and efficacy. It is also the fundament for evidence-based medicine, medical guideline development or health policy decision makings.

The decisions made in clinical practice are associated with some uncertainties. This is because medical-biological processes are governed not only by the law of nature but also random factors. Therefore, it is possible to estimate medical-biological processes, but not to calculate their exact value. Epidemiology and statistics are primarily used to first derive a general statement that then forms the theoretical basis for clinical practices. Clinical trials are the foundation of evidence-based medicine. Every day more than 5000 new studies are published in electronic databases. Thus, the number of studies and the information gain is enormous.

In order to interpret the data, and critically assess these clinical trials, one must possess an understanding of the basic principles in conducting a clinical trials, epidemiology, and statistics. This is important in order to understand the fundaments in clinical research for advancing medical knowledge and ultimately improving patient care, whether it being a physician, researcher, or data scientist.

Endnote

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iDicker R. Principles of epidemiology in public health practice. 3rd ed. CDC; 2006.

Chapter 2

Evidence-based medicine

Abstract

Evidence-based medicine (EBM) is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The best evidence is the scientifically proven effectiveness that is determined based on clinical trials using epidemiological and statistical methods. The term evidence-based medicine was introduced in the early 1990s by Gordon Guyatt and David Sackett at McMaster University, Hamilton, Canada. The combination of three components; physician, patient, and evidence defines EBM. EBM is a systematic approach to clinical problem solving which allows the integration of the best available research evidence with clinical expertise and patient values. The approach to EBM in a clinical setting, includes the formulation of a clinical question that is related to the patient treatment, identification of relevant literature, evaluation of evidence, selection of evidence, implementation, and