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.


It is indeed very heartening and equally gratifying that Dr. S. S. Patel, Former Dean of Jawaharlal Nehru Medical College, SawangiMeghe, Wardha, and presently the Chief Coordinator of DattaMeghe Institute of Medical Sciences (Deemed to be University), has ventured in bringing out a creative, magnificent creation in the form of this Book titled “Elements of Study Designs, Clinical Biostatistics and Clinical Research.”

It is imperative and inevitable to note that the objectives of medical education are very clearly crystallized globally in the international Charter that has been worked out under the joint signatures of all the countries across the Globe, which mandate that the trained Graduate and also the specialist generated thereto should turn out to be a good clinician, an effective medical teacher, and a keen researcher. The trinity of objectives, when assessed in terms of manifestation, categorically brings out that the keen researcher part of it remains in limbo for wide and varied reasons.

It is in this very context one is required to take cognizance of a material reality that in spite of having the highest number of medical schools in India as compared to any other part of the world and thereby having the highest annual intake capacity for graduate and various broad specialties postgraduate courses whereby the highest quantum of trained, skilled health manpower is generated. Yet, the contribution of the said manpower in the domain of research output in the arena of medical sciences globally is minuscule in nature, bringing out the grossest possible mismatch.

This research output deficit is not accidental in nature. On the contrary, it is primarily because of the impoverished orientation of the learner in the domain of research principles, research methodology, and research ethics. The emphasis which is laid down at the various levels of learning on training and orientation in respect of research principles and methodology is non-existent in as much as it turns out to be an arena of least priority. Consequent to this prevailing situation, the learner as output is totally unequipped to dispense the research output expectations out of him in any manner whatsoever.

In addition, another problem that plagues the educational scenario in medical colleges in the country is the grossest paucity of reading material in the said arena, which could be availed for teaching, training, and learning purposes. The material that is availed as of now falls short with respect to the orientation of the learner emphatically in the domain of clinical research, especially in the context of clinical Biostatistics and the arena of clarity in regard to the elements with reference to study designs. More often than not, the said arena is deciphered on the required occasions through conjectural means and modes in the absence of the required clarity. Therefore, the assistance turns out to be inconsistent with the material requirement.

These vital lacunae that are operational in the system of medical education as of now need serious grappling at various levels in order to create an appropriate academic ambiance on the said count. However, the most important lacuna in regard to the paucity of the handy reading material on the said count is adequately and sumptuously dealt with by the elegant authorship that is brought out in this book.

The topics compiled in the book are vital and significant in ‘general’ as a whole, but the significant aspect is the emphasis that is worked out in the embodied chapters, significantly facilitatory in an analytical understanding of the requirements thereto. The topic of study designs in ‘Medical research’ brings out an easily decipherable depiction of understanding the patterns of study design and the edifice of the nomenclature thereto, which is bound to go well with the learner in a huge way.

Likewise, the chapter on scales of measurements, descriptive statistics, and research data presentation brings out handy workable operational modes and modalities on the required count that is bound to give the learner enriched with clarity on the vital areas of research methodology, enabling him to grapple with the said issues on his own and emerge out successfully in the said venture.

The chapter on inferential statistics is brought out in an easy, handy, and free-flowing manner whereby the jargon depictions which otherwise baffle a learner on the said area are replaced by easily understandable modes and manners that bring out handy understanding in the learner capable of availing the same with responsibility and capacity to bring the desired outcome thereto.

The depiction of statistical methods for a relationship of variables which otherwise is tough to correlate with reference to the required ambit thereto is invoked in such a lucid manner that it is bound to equip the learner with the required capacity to work out the same on his own and thereby making him free and immune from his compulsory dependence on statisticians in a blind manner. On this count, the chapter turns out to be a beacon’s light in the existing otherwise dominating darkness in the said arena of indulgence and the resultant operations thereof. The soul of inclusions in this notable book is the chapter on ‘Clinical Research’, which has brought out the expertise of the author in emphatic and self-speaking turns in a vociferous manner. He has poured the life long experience of his into this chapter to make any and every reader decipher the scope, meaning, and ambit of what is designated as ‘Clinical research’ including the manifestations that are expected out of it for the purposes of its translational accomplishments in larger societal interests. This opens genuine and wide vistas of focused understanding in the otherwise non-decipherable domain of clinical research.

It is said ‘what is ethically wrong cannot be legally just and political right,’ hence the paramount need for incorporation of ethicality in research in modes, manners, operations, and outcomes. The governing ethical principles of research emanating from the ‘Helsinki Declaration’ till the guidelines notified by the Indian Council of Medical Research and their operational utilization is the hallmark of the embodied chapter on Ethics in Clinical Research.

The vital aspect of research methodology and its resultant outcome in terms of publications and potentization also mandates that the research scholar has to be adequately equipped and armed with the much-needed armory of being an efficacious planner and writer of research projects seeking much-needed funding for the said purpose by the various statutory funding agencies including the non-governmental organizations that carter to the said cause. It categorically brings out that writing research projects is not ‘an Art’ but a definitive science mandating a required approach, commensurate structuring, needed inclusions, and depictions in regard to operations, outcome, expected translator component and the operational modes and manners thereto.

Speaking for the special feature of the book from beginning to end, the only expression at my disposal is that it is a ‘treatise’ on ‘elements of study design, clinical biostatistics and clinical research’ which is made easy, handy, free-flowing decipherable and usable by one and all independent of the status or the level of the user. As such, the creative writing that the author has invoked is bound to be of immense use to the user from the point of view of clarity of understanding, utility, and purpose fulfillment, but it is bound to fill in a huge void that remains unfilled all these years for wide and varied reasons. The impact it generates is unending and would turn out to be an illuminating source of light devouring the prevalent darkness in its entirety in the true spirit of the Vedic hymn depicting ‘Tamaso Ma Jyotirgamay.’

I would be failing in my duty if I did not wholeheartedly salute the diligent effort of the author whom I have known for over three decades and have always found inspiring as a mentor to all concerned. But the mentorship that is bound to be generated out of this creative manifestation of his in this book leads him to a state of ‘immortality’ which otherwise is the toughest and most difficult of the attainments in human life.

Vedprakash Mishra
Datta Meghe Institute of Higher Education and Research,
Sawangi (Meghe),
Nagpur, Maharashtra,