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 Additionally, many are no longer current.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.

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

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 examples of 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 pre-specifying 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 pre-specified 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 a minimum, the statistician may still find the principles and fundamentals presented in this text useful.

This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

* Provides a single resource for those starting out in research * Practical advice for both clinical and scientific research * Comprehensive accounts of topics not easily accessed elsewhere * Points out the major pitfalls to the inexperienced * Presents the experts view and the hard facts

Are you aspiring or pursuing a career in health research? Are you inquisitive about how health research is planned and implemented? You could be a student, a physician or surgeon, a public health practitioner, a health counsellor, a research associate, a nurse, a pharmacist, a data manager, a project manager, an ethics committee member or just curious! Health Research Fundamentals is the book to start with to be a competent public health researcher. This book is a primer on health research methods, with an effective combination of theoretical foundation and practical experiences. Fully appreciative of the fact that there may not always be a single best approach to health research, the goal here is to provide you with an overview of the principles and steps involved in biomedical and health research. This book will: • Walk you through the systematic process of conceptualising, designing, planning, proposing, conducting and reporting a health research study. • Give you a head start whether you are concerned with clinical research and clinical trials, patient-oriented research, epidemiologic studies, behavioral science, translational research, or health services-related research. Get onboard to a stimulating journey of demystifying health research fundamentals!

This unique text explores the patient-physician relationship, focusing on those relationships and societal problems that can have an impact on it. Writing for first- and second-year medical students, Drs. Mengel and Holleman describe the process of developing into a physician and how that affects the individual; the many cultural issues that can impact on the patient; and the current economic forces affecting the quality of health care. Students will benefit from the cogent clinical examples and cases that illustrate important points and the suggested supplementary readings.

The essential textbook for HIV care providers and pharmacists--updated for 2023! Fundamentals of HIV Medicine has served as a key resource for clinicians preventing and treating HIV for over a decade. An end-to-end clinical resource for the treatment of individuals with HIV/AIDS, Fundamentals of HIV Medicine 2023 offers practitioners immediate, indexed access to the most recent science, research, and guidelines related to all aspects of HIV care and prevention. Now updated to reflect the convergent knowledge at the intersection of two global pandemics, HIV and COVID-19, Fundamentals of HIV Medicine 2023 offers state-of-the-art continuing education for physicians, pharmacists, nurse practitioners, physician assistants, nurses, and other professionals working in the care of HIV patients. This revised edition features key clinical updates across classic domains of HIV medicine along with new understandings of injectable antiretroviral treatment and explorations into concepts of HIV latency for long-term viral remission. Embodying the American Academy of HIV Medicine's commitment to excellence in the care of seropositive patients, Fundamentals of HIV Medicine 2023 is a must-have for health professionals across HIV care, treatment, and prevention.