Editors: S.S. Patel, Aditya Patel

Elements of Clinical Study Design, Biostatistics & Research

eBook: US $39 Special Offer (PDF + Printed Copy): US $63
Printed Copy: US $43
Library License: US $156
ISBN: 978-981-5123-80-7 (Print)
ISBN: 978-981-5123-79-1 (Online)
Year of Publication: 2023
DOI: 10.2174/97898151237911230101


Elements Of Clinical Study Design, Biostatistics & Research is designed as a toolbox for biomedical researchers. The book's primary focus is on applications in clinical research, and will benefit students and researchers involved in the biomedical field. This book addresses the problems that many practitioners experience in choosing and implementing fit-for-purpose data analysis methods to answer critical inferential questions for binomial and count data. The book is written in simple language avoiding complex derivations and mathematical formulae allowing it to explain the most basic concepts of research methodology. Making good use of numerous tables, graphs and tips, this book demystifies the process for readers.

7 structured Chapters take the reader through the entire research process: choosing a question, designing a study, collecting the data, using univariate, bivariate, and multivariable analysis, and publishing the results. Each chapter discusses the strengths and weaknesses of the methods and suggests practical recommendations. An appendix on ethical research guidelines, along with a glossary and reference list comprehensively round up the book contents.

It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of studies. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in the areas of biostatistics, epidemiology, medicine, pharmacy, and public health.


The word statistics is derived from the Latin word ‘Status’, meaning position or standing. As the skills of statistics were used by the tax assessor to assess the ‘Position’ or ‘Standing’ in society, i.e., the assessment of the assets of an individual. Presently the term statistics is used for analyzing data and taking out inferences.

The theory of statistics was developed by mathematicians to predict something based on previous observations or information they proved through mathematical equations. Statistics are used even in our day-to-day activities by way of taking out averages, means, and ranges. In the field of sports, statistics are increasingly used for making predictions and in administrative decision-making. Cricket is one such example wherein statistical analysis provides strong support in team selection. Statistical formulae, if applied intelligently, can assist all types of decision-making.

For example: Calculating the number of beds required in the Intensive Care Unit of a hospital or the number of ambulances needed in the Casualty section of a hospital.

Health science researchers and clinicians who make clinical decisions based on available research inputs have got to have sound knowledge of what is known as Medical Biostatistics or Clinical Biostatistics. One of the most important uses of biostatics is in epidemiological studies. The term medical epidemiology refers to the study of health and diseases in the human population. Health professionals, especially clinicians and medical researchers, must know whether the published information is worth utilizing in decision-making. The editors of journals usually screen the research articles from the point of view of organization and analysis of the research material. Their focus is on the contents rather than methodology, including the suitability of applying the statistical tools. As such, expert statistical consultation should be sought during the planning of any research project with clarity of the research question to be answered. There is good documentation of problems with medical research articles.

Williamson et al. (1992) remarked that out of 4200 medical studies published in 30 Journals, which included the British Medical Journal, Journal of the American Medical Association, New England Journal of Medicine, Canadian Medical Association Journal, and Lancet, only about 20% articles met the assessor's criteria for validity.

Practitioners in medicine read the research articles to apply the results of research inpatient care for diagnostic and therapeutic purposes. The medical researchers review the research articles to find out the research gap and design a study to fill the research gap. A sound understanding of research methods and biostatics is indispensable for the interpretation of information about drugs, equipment, and diagnostic procedures, for evaluating study protocols and research articles and for participation in research projects. It is very important for a researcher, specifically in health sciences, to have skills to interpret to publish results and can make decisions on whether the statistical tests are used properly.

This title is intended to be used by researchers in health sciences, academicians, and clinicians to make them understand the basic concept of research and biostatistics so that they can make effective and efficient use in their respective fields of their indulgence.

The researcher is expected to know only which study design is best suited to answer his/her research question and which statistical test is appropriate to draw reliable inferences from the research data. Although a good number of books are available on Biostatistics, most of them deal with core or classical parts of statistics and their application procedures in quite detail. The medical researcher finds it difficult to select the contents of his requirement suited for the application. In this work, details have been curtailed based on my experience as a learner, guide, and supervisor of research in Medicine, Dental Sciences, and the Indian System of Medicine. I hope this book will serve the intended purpose.


Not applicable.


The author declares no conflict of interest, financial or otherwise.

Satyawan Singh Patel
Centre of Excellence for Preclinical Safety & Efficacy Studies
Interdisciplinary Research and Therapy Evaluation
DattaMeghe Institute of Medical Sciences, (Deemed to be University)
NAAC Accredited Sawangi(Meghe),DMIMS (DU)
Nagpur, India