Clinical trials : design, conduct, and analysis / Curtis L. Meinert.

Includes bibliographical references and index.

Cover; Contents; PART 1. INTRODUCTION; Chapter 1 Introduction; 1.1 Clinical trial: Definition; 1.2 History of clinical trials; 1.3 Trials today; 1.4 Terminology: Conventions and definitions; 1.5 Focus; Chapter 2 The language of clinical trials; 2.1 Introduction; 2.2 On the language of relativity; 2.3 Random: The term; 2.4 The language of the epidemiologist vs the trialist; 2.5 Terminology: Recommendations and comments; Chapter 3 Types and classes of trials; 3.1 Introduction; 3.2 Treatment structure; 3.3 Sample size design; 3.4 Masking design; 3.5 Single-center and multicenter trials. 3.6 Purpose3.7 Treatment modality; 3.8 Big and simple trials; 3.9 Industry trials versus academic trials; Chapter 4 The state and nature of trials; 4.1 Introduction; 4.2 On assessing the state and nature of trials; 4.3 Published trials; 4.4 Gender-specific trials; 4.5 The Cochrane Library; 4.6 Registration of trials; 4.7 Registries of trials; 4.8 Other state measures; Chapter 5 The activities of clinical trials; 5.1 Stages of activities; 5.2 Division of responsibilities; 5.3 Impediments to performance of activities; 5.4 Aids to ensuring orderly transition of activities. Chapter 6 Coordinating and other resource centers in multicenter trials6.1 Introduction; 6.2 Coordinating centers; 6.3 Study chair and office of the study chair; 6.4 Central laboratories; 6.5 Reading centers; 6.6 Project offices; 6.7 Support centers; Chapter 7 Multi-study networks; 7.1 Introduction; 7.2 Examples of networks; 7.3 Advantages and disadvantages; 7.4 Modes of creation and funding; 7.5 Organizational structures; 7.6 Operating structures; Chapter 8 Ethical principles and imperatives in clinical trials; 8.1 Introduction; 8.2 Medical research codes. 8.3 Principles of medical ethics in research8.4 The state of clinical equipoise; 8.5 The ethics of choice of study treatments; 8.6 The monitoring imperative; 8.7 The ethics of disclosures for consents and of confl icts of interest; Chapter 9 Objectivity versus competency in clinical trials; 9.1 Introduction; 9.2 Objectivity constructs and rules; 9.3 Ethical limits of imposed objectivity constructs; PART 2. DESIGN PRINCIPLES AND PRACTICES; Chapter 10 Fundamentals of controlled clinical trials; 10.1 Introduction; 10.2 Choice of the test and control treatments. 10.3 Principles in the selection of the outcome measure10.4 Principles of establishing comparable treatment groups; 10.5 Principles of masking and bias control; Chapter 11 Bias; 11.1 Introduction; 11.2 Absolute versus relative truth and bias; 11.3 Selection and representation biases; 11.4 Treatment-related biases; 11.5 Indicators of bias; 11.6 Bias "fix," avoidance, and prevention strategies; Chapter 12 Bias control; 12.1 Introduction; 12.2 Randomization; 12.3 Concealment; 12.4 Masking philosophy of the trialist; 12.5 Specificity, training, and surveillance.

"First published in 1986, this landmark text is the definitive guide to clinical trials, written by one of the leading experts in the field. This fully-updated second edition continues to be the most authoritative reference text on randomized clinical trials. It contains a wealth of practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail on such issues as sample size calculation, stratification and randomization, data systems design, development of consent forms, publication policies, preparation of funding requests, and reporting procedures. While the basics of design, conduct, and analysis of clinical trials remain the same, there have been significant changes since the first edition of Clinical Trials was published two decades ago. In this new edition, the author discusses the refinements and improvements made to methods and procedures, changes in the policies and guidelines underlying trials, as well as requirements for registration of trials. He also discusses current practices for data sharing, for gender representation, for treatment effects monitoring, and for ethical standards of clinical trials. The importance of the randomized controlled trial has grown significantly over time and they are now the cornerstone of all evidence-based medicine. Still rich in tables, checklists, charts, and other resources for the trialist, the second edition of Clinical Trials is an indispensable reference for clinicians, biostaticians, epidemiologists, and anyone involved in the design and implementation of a clinical trial"--Provided by publisher.