Red Flower Publications

Biostatistical Methods for Medical Research

Editor(s)/Author:

Dr. Sanjeev Sarmukaddam

Status: Available

Publication Year: 2019-04-01

First chapter is devoted to describe all general aspects (i.e. methodology in details) of a clinical study in context of superiority type of clinical trial as illustration. Rest of the chapters focus on particular/specific aspect [specified in title of the chapter). Most of the types of ‘design’ are thoroughly discussed along with estimation of required sample sizes. Many other related aspects like ‘bias’; sub-group analyses; adaptive procedures; meta-analysis; CONSORT guidelines; interim analyses, are covered in simple manner. Most of the important points are described in the book like ‘How to Analyze Change from Baseline: Absolute or Percentage Change?’ & ‘Clinically meaningful effect’ (more on ‘Effect Size’).

Unique points of the book

Most of the new or rarely used designs of clinical trials are discussed. General procedure of determining sample size and formulas to be used in various situations are given. Confidence interval estimation for various measures/statistic (including difference in means or proportions, RR, AR, OR, Hazard ratio, NNT) is/are discussed in adequate details. Interaction tests [w.r.t. ‘proportions’, ‘means’, ‘ratios’ with their need and way of performing them] are described in greater details. Contrasting and differentiating between Standard Deviation & Standard Error, Confidence Interval & Tolerance Interval and Clinical significance & Statistical Significance is discussed adequately. Effect Modification is defined with examples. Missing Data & few important Imputation Techniques; Interim analysis; Adaptive Procedures; and many other related issues like ICH & GCP guidelines; CONSORT Statement; Safety Index; Quality control; Other quantitative aspects of clinical reasoning; Validity and Reliability; Clinical Disagreement; Qualitative Research Methods; Systematic reviews and Meta analysis; Ascertainment correction in rates are covered in sufficient details.

About the Book vii
About the Author ix
Preface xi
Acknowledgement xv
Chapter 1: Methodology Generally Used in Clinical or Medical Research 1
Chapter 2: Different Designs for Clinical or Medical Research 19
Chapter 3: Description of Data and Basic Concepts of Probability for Clinical or Medical Research 69
Chapter 4: Presentation and Summarization of Data for Clinical or Medical Research 80
Chapter 5: Measures with their Confidence Intervals, and Logic of Statistical Testing for Clinical or Medical Research 95
Chapter 6: Statistical Inference for Clinical or Medical Research 129
Chapter 7: Time-to-event (or Survival) Data & Person Time Data Analysis for Clinical or Medical Research 159
Chapter 8: Miscellany – Brief Notes on Various Other Important Issues in Clinical or Medical Research 174
Chapter 9: Correlation, Linear Regression and Multivariable (or Multivariate) Statistics for Clinical or Medical Research 239
Chapter 10: Regulatory and ethical aspects in Clinical or Medical Research [Particularly in India] 259
Appendix A1 266
Appendix A2 267
Appendix A3 268
Appendix A4 269
Index for Biostatistics for Clinical or Medical Research 270

He is M.Sc. in Biometry from Department of Statistics, University of Pune; D.B.S. (P.G. Diploma in Biostatistics) from ICMR's Institute for Research in Medical Statistics, [presently known as National Institute of Medical Statistics], New Delhi; M.P.S. (Master of Population Studies) from International Institute for Population Sciences, Bombay; and Ph.D. in Biostatistics (topic: Some Inferential Problems in Epidemiology) from School of Health Sciences, University of Pune. He has taught Biostatistics in many Medical Colleges/institutions & Universities (including National Institute of Mental Health and Nuero Sciences, Bangalore and Institute for Research in Medical Statistics, New Delhi, as permanent faculty member for 3 years each & at Pune University as guest faculty for 5 years). On special invitation, he also lectured at Lawrence Education Center of Borgess Medical Center (arranged by Department of Community Health) of University of Michigan, USA in their ‘grand rounds’. His presentation during International Biometric Conference held at McGill University, Montreal, Quebec, Canada and at many places of academic interest in London, UK was appreciated. He participated, on special invitation, in symposium on “Controversies in Clinical Trials” and also in 11th International Congress of Behavioral Medicine at Grand Hyatt Washington (2010).

He has more than 50 scientific publications in peer reviewed international journals [total Publications/Presentations being more than 80, of which most can be seen/searched/browsed on WWW/net/pub-med] & had received a Gold Medal along with “Prof. B.G. Prasad award-1987” by the Indian Society for Medical Statistics, for best published paper (of the year) on Statistics applied to Epidemiology. He works on ‘Statistical Advisory Board’ of international journal ‘PLOS ONE’. He co-authored a book in 2001 titled “Medical Biostatistics” published by a New York (USA) based publisher Marcel Dekker, Inc. This book consisting of 664 pages has ISBN: 0-8247-0426-6. He is the sole author of four other books, recent being “Methods & Controversies in Clinical Trials”. He is a member/member secretary of many of the ‘Institutional Ethics Committee’s, member of ‘Scientific/Research Advisory Committee’, Ph.D. Advisory Committee and many ‘DSMBs’.

After retirement from Maharashtra Institute of Mental Health, B.J. Medical College & Sassoon Hospital, Pune, India (on 31.07.2015) he is associated as Honorary / Adjunct Research Professor with many organizations/research groups.