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Elsevier

Books in Clinical trials

Supporting researchers, clinicians, and regulatory professionals, this portfolio emphasizes trial design, ethical considerations, and statistical analysis. It features innovations in trial methodology, real-world evidence, and regulatory compliance that accelerate drug development and facilitate evidence-based healthcare advancements.

  • A Comprehensive Guide for the Novice Researcher in Clinical Trials

    • 1st Edition
    • Miltiadis Lytras + 2 more
    • English
    A Comprehensive Guide for Novice Researcher in Clinical Trials is a must-have resource for individuals embarking on the journey of clinical research. This book is tailored for beginners, offering a clear and structured introduction to the vital principles, methodologies, and skills required to design and conduct robust clinical trials. Spanning 13 chapters, it meticulously covers the entire clinical trial process, emphasizing Good Clinical Practice (GCP) standards. From foundational research concepts to advanced trial strategies, the guide empowers readers to confidently navigate the complexities of clinical trials and contribute meaningfully to the field of healthcare.In addition to its foundational content, the book addresses a variety of important topics, such as ethical considerations, regulatory compliance, and the development of trial protocols. It explores different trial designs, types of bias, and the historical evolution of clinical research. Practical sections on data management, monitoring, statistical analysis, and project management offer readers hands-on guidance for real-world application. Notably, the book includes a dedicated focus on regulatory affairs in Saudi Arabia, making it particularly valuable for health professionals in that region.

  • Fundamentals of Biologicals Regulation

    Vaccines and Biotechnology Medicines
    • 2nd Edition
    • Rebecca Sheets + 6 more
    • English
    This second edition of Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. In this new edition the book provides more in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans and REMS, and switching from reliance on in vivo to in vitro analytical methods. This new edition also reflects the new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes for students. This book provides multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions with emphasis on the European Medicines Agency and the U.S. Food and Drug Administration. Graduate students will benefit from the new pedagogic features. Regulatory professionals will have in Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines a complete guide to navigate through the approval process.

  • Clinical Trials and Tribulations

    • 1st Edition
    • Gayathri De Lanerolle + 2 more
    • English
    Clinical Trials and Tribulations evaluates the multiple layers of complexities around research management, also exploring current practices, challenges and future directions. The book provides answers to readers questions and problems through extensive use of real-world examples, case studies and lessons learned. Following an approach to provide pragmatic viewpoints as well as concepts and methodologies and its alignment with specific practices, the book explores paradigms between planning and conducting research in academia vs. healthcare vs. industry in the UK vs. Europe vs. America. It highlights practical solutions to real-world complex issues that have been documented by independent regulators. This will be an indispensable book for all staff working in clinical research within healthcare, academia and industry, as well as students intending to work in clinical trials.

  • Laboratory Animal Anaesthesia and Analgesia

    • 5th Edition
    • Paul Flecknell
    • English
    Laboratory Animal Anaesthesia and Analgesia, Fifth Edition provides a basic guide to anesthesia for a very diverse audience involved in animal testing. This has been the go-to resource for current, clear and evidence-based information for over 30 years. The book is divided into four parts that deal with preparation for anesthesia, including definitions, equipment, preparations, anesthetic and analgesic agents, the management and monitoring of anesthesia, including pre-procedural preparations, monitoring and problems and emergencies through the procedure, advanced and specialized techniques, and analgesia and post-operative care, including recovery and the prevention and management of post-operative pain. Final sections cover anesthesia in common laboratory species, specifically: rodents, rabbits, cats, dogs, ferrets, pigs, sheep and goats, primates, reptiles, amphibians and new specific chapters on birds, fish and cephalopods. This edition keeps up with the tradition of bringing a balanced dose of practical advice, foundational content, and current, updated references, drugs and procedures to veterinarians, technicians, researchers and ethics committee personnel.

  • The Practical Guide to Clinical Research and Publication

    • 1st Edition
    • Uzung Yoon
    • English
    The Practical Guide to Clinical Research and Publication provides a comprehensive overview of the key foundations of epidemiology, statistics and epidemiological studies. This book presents the most important terms and knowledge in the field from a medical point-of-view. Sections contain numerous, clinically-oriented examples and drawings to facilitate understanding and clarify the relation to clinic and practice. The book contains many graphics and key points for easier understanding and is written using bullet points for ease of use and comprehension. It is ideal for physicians and clinical researchers who want to use it as guidance for clinical research or teaching.

  • Practical Biostatistics

    A Step-by-Step Approach for Evidence-Based Medicine
    • 2nd Edition
    • Mendel Suchmacher + 1 more
    • English
    Practical Biostatistics: A Step-by-Step Approach for Evidence-Based Medicine, Second Edition presents a complete resource of biostatistical knowledge meant for health sciences students, researchers and health care professionals. The book's content covers the investigator’s hypothesis, collective health, observational studies, the biostatistics of intervention studies, clinical trials and additional concepts. Chapters are written in a didactic way, making them easier to comprehend by readers with little or no background on statistics. Evidence-based medicine aims to apply the best available evidence gained from the scientific method to medical decision-making using statistical analyses of scientific methods and outcomes to drive further experimentation and diagnosis. With a detailed outline of implementation steps complemented by a review of important topics, this book can be used as a quick reference or hands-on guide on how to effectively incorporate biostatistics in clinical trials and research projects.

  • Considering the Patient in Pediatric Drug Development

    How Good Intentions Turned Into Harm
    • 1st Edition
    • Klaus Rose
    • English
    Considering the Patient in Pediatric Drug Development: How Good Intentions Turned into Harm addresses a fundamental challenge in drug development and healthcare for young patients. In clinical trials and clinical practice, the term "children" is used ambiguously to confer physiological characteristics to a chronological age limit, which in reality does not exist. This book outlines why the United States (US) and European Union's (EU) regulatory authorities, pediatric academia, and the pharmaceutical industry demand, support and perform pediatric drug studies, along with the key flaws of this demand that blurs the different administrative and physiological meanings of the term "child." In addition, the book covers why most pediatric regulatory studies lack medical sense and many even harm young patients and the conflicts of interest behind pediatric drug studies. It includes relevant information about the maturation of the human body regarding absorption, distribution, metabolism and excretion of food and drugs as well as key differences between newborns, infants, older children and adolescents.

  • Pregnancy and the Pharmaceutical Industry

    The Movement towards Evidence-Based Pharmacotherapy for Pregnant Women
    • 1st Edition
    • Kristine E. Shields
    • English
    Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and effectiveness of medications used during pregnancy as it is impossible to extrapolate that information from drug studies on men and non-pregnant women. As a majority of pregnant women confront a medical condition during their pregnancy, from simple pain, to ongoing or new medical issues, this book quantifies the current absence of pregnant women in drug studies and identifies ethical issues, barriers, litigation fears and opportunities. Those in the pharmaceutical industry, IRB members who approve or deny drug study plans, doctors, nurses and midwives working in obstetrics or involved in conducting studies at their institutions will find this book an essential resource.

  • The Sourcebook for Clinical Research

    A Practical Guide for Study Conduct
    • 1st Edition
    • Jeff Nelligan + 1 more
    • English
    A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website, so that study teams will be compliant and will find all the necessary tools within this book. Additionally, the authors developed Display Posters for Adverse Events Plus Reporting and Medicare Coverage Analysis that can be purchased separately here: https://www.elsevier... Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic.

  • An Overview of FDA Regulated Products

    From Drugs and Cosmetics to Food and Tobacco
    • 1st Edition
    • Eunjoo Pacifici + 1 more
    • English
    Approx.270 pages

  • A Comprehensive and Practical Guide to Clinical Trials

    • 1st Edition
    • Delva Shamley + 1 more
    • English
    A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end.

  • Clinical Trials

    Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
    • 2nd Edition
    • Tom Brody
    • English
    Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.

  • Research Regulatory Compliance

    • 1st Edition
    • Mark A. Suckow + 1 more
    • English
    Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory.

  • Global Clinical Trials for Alzheimer's Disease

    Design, Implementation, and Standardization
    • 1st Edition
    • Menghis Bairu + 1 more
    • English
    Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease.

  • Spontaneous Animal Models of Human Disease

    • 1st Edition
    • Volume 2
    • Edwin J. Andrews + 2 more
    • English
    This two-volume work gathers together the diverse information presently available on spontaneous animal models of human disease. In addition to providing a comprehensive review of existing models, the book presents many previous unpublished new models.The scope of this work is limited to spontaneous models. Neoplasia, infectious diseases including parasitism, and nutritionally induced or other types of experimental models have not been included. The sixteen parts of the book are alphabetically arranged according to organ system with over 230 authors contributing to the overall effort. In addition to many illustrations, the book features an extensive bibliography.

  • Practical Biostatistics

    A Friendly Step-by-Step Approach for Evidence-based Medicine
    • 1st Edition
    • Mendel Suchmacher + 1 more
    • English
    Evidence-based medicine aims to apply the best available evidence gained from the scientific method to medical decision making. It is a practice that uses statistical analysis of scientific methods and outcomes to drive further experimentation and diagnosis. The profusion of evidence-based medicine in medical practice and clinical research has produced a need for life scientists and clinical researchers to assimilate biostatistics into their work to meet efficacy and practical standards. Practical Biostatistics provides researchers, medical professionals, and students with a friendly, practical guide to biostatistics. With a detailed outline of implementation steps complemented by a review of important topics, this book can be used as a quick reference or a hands-on guide to effectively incorporate biostatistics in clinical trials.

  • Principles and Practice of Clinical Research

    • 3rd Edition
    • John I. Gallin + 1 more
    • English
    The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.

  • Clinical Research in Asia

    Opportunities and Challenges
    • 1st Edition
    • U Sahoo
    • English
    Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis).

  • Global Clinical Trials Playbook

    Capacity and Capability Building
    • 1st Edition
    • Menghis Bairu + 1 more
    • English
    Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials.

  • Clinical Trials

    Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines
    • 1st Edition
    • Tom Brody
    • English
    Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.

  • Strategy and Statistics in Clinical Trials

    A Non-Statisticians Guide to Thinking, Designing and Executing
    • 1st Edition
    • Joseph Tal
    • English
    Strategy and Statistics in Clinical Trials deals with the research processes and the role of statistics in these processes. The book offers real-life case studies and provides a practical, how to guide to biomedical R&D. It describes the statistical building blocks and concepts of clinical trials and promotes effective cooperation between statisticians and important other parties. The discussion is organized around 15 chapters. After providing an overview of clinical development and statistics, the book explores questions when planning clinical trials, along with the attributes of medical products. It then explains how to set research objectives and goes on to consider statistical thinking, estimation, testing procedures, and statistical significance, explanation and prediction. The rest of the book focuses on exploratory and confirmatory clinical trials; hypothesis testing and multiplicity; elements of clinical trial design; choosing trial endpoints; and determination of sample size. This book is for all individuals engaged in clinical research who are interested in a better understanding of statistics, including professional clinical researchers, professors, physicians, and researchers in laboratory. It will also be of interest to corporate and government laboratories, clinical research nurses, members of the allied health professions, and post-doctoral and graduate students.

  • Clinical and Translational Science

    Principles of Human Research
    • 1st Edition
    • David Robertson + 1 more
    • English
    Clinical or translational science is the field of study devoted to investigating human health and disease, interventions and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. New molecular tools and diagnostic technologies based on clinical and translational research have lead to a better understanding of human disease and the application of new therapeutics for enhanced health. Clinical and Translational Science is designed as the most authoritative and modern resource for the broad range of investigators in various medical specialties taking on the challenge of clinical research. Prepared with an international perspective, this resource begins with experimental design and investigative tools to set the scene for readers. It then moves on to human genetics and pharmacology with a focus on statistics, epidemiology, genomic information, drug discovery and development, and clinical trials. Finally, it turns to legal, social, and ethical issues of clinical research concluding with a discussion of future prospects to provide readers with a comprehensive view of the this developing area of science.

  • Principles and Practice of Clinical Trial Medicine

    • 1st Edition
    • Richard Chin + 1 more
    • English
    Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.

  • Handbook of Neuroemergency Clinical Trials

    • 1st Edition
    • Wayne M. Alves + 1 more
    • English
    During the 1990’s, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were “tested,” and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors’ perspectives.