Clinical Trial Registries by
ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results.
Clinical Trials by
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 practicalinformation 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 andprocedures, 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 ofthe 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.
Fundamentals of Clinical Trials by
The clinical trial is "the most definitive tool for evaluation of the applicability of clinical research." It represents "a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments" [1]. It has been called on many occasions, "the gold st- dard" against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2-21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.
Genomic Clinical Trials and Predictive Medicine by
Genomics is majorly impacting therapeutics development in medicine. This book contains up-to-date information on the use of genomics in the design and analysis of therapeutic clinical trials with a focus on novel approaches that provide a reliable basis for identifying which patients are most likely to benefit from each treatment. It is oriented to both clinical investigators and statisticians. For clinical investigators, it includes background information on clinical trial design and statistical analysis. For statisticians and others who want to go deeper, it covers state-of-the-art adaptive designs and the development and validation of probabilistic classifiers. The author describes the development and validation of prognostic and predictive biomarkers and their integration into clinical trials that establish their clinical utility for informing treatment decisions for future patients.
Modern Clinical Trial Analysis by
This volume covers classic as well as cutting-edge topics on the analysis of clinical trial data in biomedical and psychosocial research and discusses each topic in an expository and user-friendly fashion. The intent of the book is to provide an overview of the primary statistical and data analytic issues associated with each of the selected topics, followed by a discussion of approaches for tackling such issues and available software packages for carrying out analyses. While classic topics such as survival data analysis, analysis of diagnostic test data and assessment of measurement reliability are well known and covered in depth by available topic-specific texts, this volume serves a different purpose: it provides a quick introduction to each topic for self-learning, particularly for those who have not done any formal coursework on a given topic but must learn it due to its relevance to their multidisciplinary research. In addition, the chapters on these classic topics will reflect issues particularly relevant to modern clinical trials such as longitudinal designs and new methods for analyzing data from such study designs. The coverage of these topics provides a quick introduction to these important statistical issues and methods for addressing them. As with the classic topics, this part of the volume on modern topics will enable researchers to grasp the statistical methods for addressing these emerging issues underlying modern clinical trials and to apply them to their research studies.
A Practical Guide to Human Research and Clinical Trials by
Regulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, A Practical Guide to Human Research and Clinical focuses on ethics, regulations, and guidelines. Conducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.