Description

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 Author/Editor

Dr. Sanjeev Sarmukaddam