"Fundamentals of Clinical Trials" is a comprehensive guide to the design, conduct, analysis, and reporting of clinical trials. The fourth edition, authored by Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, updates the previous edition to reflect recent advancements in clinical trial methodology. The book aims to help investigators improve the quality of clinical trials by discussing fundamental concepts with examples from their experience and the literature. It is intended for both experienced investigators and those conducting trials for the first time, as well as for use in teaching clinical trial methodology and assisting in the evaluation and interpretation of published trial reports. The book covers the rationale and phases of clinical trials, ethical issues, the questions clinical trials seek to answer, the study population, basic study design, the randomization process, blindness, sample size, baseline assessment, recruitment of study participants, data collection and quality control, assessment of adverse events, health-related quality of life, participant adherence, survival analysis, monitoring response variables, issues in data analysis, closeout procedures, reporting and interpreting results, and multicenter trials. It emphasizes the importance of adhering to fundamental principles in clinical trial design and conduct, and provides guidance on ethical considerations, data analysis, and reporting of results. The book also includes references to other texts on clinical trials and discusses the importance of proper study design, conduct, analysis, and reporting in ensuring the validity and reliability of clinical trial results. It highlights the need for careful planning, ethical considerations, and the use of appropriate statistical methods in clinical trials. The authors emphasize that while the field has advanced significantly, many of the fundamental principles remain unchanged, and that the examples provided are based on work in various clinical areas, including heart and lung diseases, AIDS, and cancer. The book is a collaborative effort and is based on over 40 years of experience in conducting and analyzing clinical trials."Fundamentals of Clinical Trials" is a comprehensive guide to the design, conduct, analysis, and reporting of clinical trials. The fourth edition, authored by Lawrence M. Friedman, Curt D. Furberg, and David L. DeMets, updates the previous edition to reflect recent advancements in clinical trial methodology. The book aims to help investigators improve the quality of clinical trials by discussing fundamental concepts with examples from their experience and the literature. It is intended for both experienced investigators and those conducting trials for the first time, as well as for use in teaching clinical trial methodology and assisting in the evaluation and interpretation of published trial reports. The book covers the rationale and phases of clinical trials, ethical issues, the questions clinical trials seek to answer, the study population, basic study design, the randomization process, blindness, sample size, baseline assessment, recruitment of study participants, data collection and quality control, assessment of adverse events, health-related quality of life, participant adherence, survival analysis, monitoring response variables, issues in data analysis, closeout procedures, reporting and interpreting results, and multicenter trials. It emphasizes the importance of adhering to fundamental principles in clinical trial design and conduct, and provides guidance on ethical considerations, data analysis, and reporting of results. The book also includes references to other texts on clinical trials and discusses the importance of proper study design, conduct, analysis, and reporting in ensuring the validity and reliability of clinical trial results. It highlights the need for careful planning, ethical considerations, and the use of appropriate statistical methods in clinical trials. The authors emphasize that while the field has advanced significantly, many of the fundamental principles remain unchanged, and that the examples provided are based on work in various clinical areas, including heart and lung diseases, AIDS, and cancer. The book is a collaborative effort and is based on over 40 years of experience in conducting and analyzing clinical trials.