Title
Fundamentals of Clinical Trials,Used
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This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials.This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examplesof published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include prespecifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the prespecified objectives.Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to aminimum, the statistician may still find the principles and fundamentals presented in this text useful.
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- Q: What is the page count of 'Fundamentals of Clinical Trials'? A: This book has five hundred seventy-one pages. It provides extensive coverage of clinical trials methodology.
- Q: What is the binding type of this textbook? A: The textbook is hardcover. This binding type ensures durability for frequent use.
- Q: What are the dimensions of 'Fundamentals of Clinical Trials'? A: The book measures six point four two inches in length, one point two inches in width, and nine point three inches in height. These dimensions make it suitable for easy handling.
- Q: How can I use 'Fundamentals of Clinical Trials' effectively? A: You can use this book to design clinical trials and develop protocols. It is also useful for evaluating published clinical trials.
- Q: Is this book suitable for beginners in clinical research? A: Yes, this book is suitable for beginners. It offers clear explanations and examples that can help those with limited statistical backgrounds.
- Q: What kind of reader is this book intended for? A: This book is intended for clinical researchers and practitioners. It assists in understanding and designing clinical trials.
- Q: How should I store 'Fundamentals of Clinical Trials'? A: Store the book in a dry, cool place to prevent damage. Keep it upright on a shelf to maintain its shape.
- Q: Can I clean the pages of the book? A: No, do not attempt to clean the pages. They are not designed for cleaning and may be damaged.
- Q: Is 'Fundamentals of Clinical Trials' safe for all age groups? A: Yes, the content is suitable for adult readers. It addresses clinical trial methodologies relevant to health professionals.
- Q: How does this book compare to earlier editions? A: This fifth edition includes new material and expanded chapters. It improves upon previous editions with updated examples and methodologies.
- Q: What makes this book a good choice for clinical researchers? A: This book provides foundational knowledge and practical examples for clinical trial design. It is authored by experts in the field.
- Q: What if the book arrives damaged? A: If the book arrives damaged, contact the seller for a return or replacement. Most sellers have policies to address such issues.
- Q: Is there a warranty on this textbook? A: No, textbooks typically do not come with a warranty. However, check the seller's return policy for any guarantees.
- Q: What if I have difficulty understanding the material? A: If you face difficulties, consider seeking additional resources or consulting with a knowledgeable colleague. The book aims to be accessible.
- Q: Are there resources for further learning on clinical trials? A: Yes, the book includes references and examples that can guide further research. It is a good starting point for deeper study.
- Q: Can this book help with regulatory issues in trials? A: Yes, it includes a dedicated chapter on regulatory issues. This chapter provides critical insights for conducting compliant clinical trials.