Statistical Thinking for Non-Statisticians in Drug Regulation, Second Edition, is a need-to-know guide to understanding statistical methodology, statistical data and results within drug development and clinical trials. It provides non-statisticians working in the pharmaceutical and medical device industries with an accessible introduction to the knowledge they need when working with statistical information and communicating with statisticians. It covers the statistical aspects of design, conduct, analysis and presentation of data from clinical trials in drug regulation and improves the ability to read, understand and critically appraise statistical methodology in papers and reports. As such, it is directly concerned with the day-to-day practice and the regulatory requirements of drug development and clinical trials. Fully conversant with current regulatory requirements, this second edition includes five new chapters covering Bayesian statistics, adaptive designs, observational studies, methods for safety analysis and monitoring and statistics for diagnosis. Authored by a respected lecturer and consultant to the pharmaceutical industry, Statistical Thinking for Non-Statisticians in Drug Regulation is an ideal guide for physicians, clinical research scientists, managers and associates, data managers, medical writers, regulatory personnel and for all non-statisticians working and learning within the pharmaceutical industry.

Sample Sizes for Clinical Trials, Second Edition is a practical book that assists researchers in their estimation of the sample size for clinical trials. Throughout the book there are detailed worked examples to illustrate both how to do the calculations and how to present them to colleagues or in protocols. The book also highlights some of the pitfalls in calculations as well as the key steps that lead to the final sample size calculation. Features: Comprehensive coverage of sample size calculations, including Normal, binary, ordinal, and survival outcome data Covers superiority, equivalence, non-inferiority, bioequivalence and precision objectives for both parallel group and crossover designs Highlights how trial objectives impact the study design with respect to both the derivation of sample formulae and the size of the study Motivated with examples of real-life clinical trials showing how the calculations can be applied New edition is extended with all chapters revised, some substantially, and four completely new chapters on multiplicity, cluster trials, pilot studies, and single arm trials The book is primarily aimed at researchers and practitioners of clinical trials and biostatistics, and could be used to teach a course on sample size calculations. The importance of a sample size calculation when designing a clinical trial is highlighted in the book. It enables readers to quickly find an appropriate sample size formula, with an associated worked example, complemented by tables to assist in the calculations.

Nursing Informatics: Scope and Standards of Practice describes a competent level of nursing care at each level of nursing informatics practice and provides comprehensive overviews of the dynamic and complex practice of the nursing informatics specialty. Published by ANA, this book is informed by advances in health care and professional nursing practice. It contains national standards of practice and performance that define the who, what, where, when, why, and how of nursing informatics practice and is a vital reference for: Quality improvement initiatives Certification and credentialing Position descriptions and performance appraisals Classroom teaching and in-service education programs Boards of nursing members' orientation programs and regulatory decision-making activities Nursing Informatics: Scope and Standards of Practice is intended to guide nurses, as well as administrators, legislators, regulators, legal counsel, and other interprofessional colleagues.

Whether you are new to literature reviews or working with new types of data, this book takes the guesswork out of writing your literature review. From deciding how much literature to include to managing your data, assessing your sources, and writing results, it outlines a step-by-step process that works with any data. To help you choose best approach for your research, this book includes: * Worksheets and decision aids to help you plan and organise your literature review * Worked examples and case studies to show you what - and what not - to do in practice * Troubleshooting tips and answers to all your frequently asked questions * Online access to a literature review starter template, an exercise workbook, project diary template, and a source credibility checklist. The perfect project support for any social sciences student, this edition also includes a new chapter on analysing mixed methods research.

'I am blown away by the level of detail Phil Cavell brings to his work.' - Elinor Barker MBE, multiple world champion and Olympic gold medallist 'The Midlife Cyclist is a triumph' - Cycling Plus 'An amazing accomplishment... a simple-to-understand precis of your midlife as a cyclist - you won't want to put it down.' - Phil Liggett, TV cycling commentator 'Phil is eminently qualified to write The Midlife Cyclist. Well, he is certainly old enough.' - Fabian Cancellara, Tour de France rider and two-time Olympic champion Renowned cycling biomechanics pioneer, Phil Cavell, explores the growing trend of middle-aged and older cyclists seeking to achieve high-level performance. Using contributions from leading coaches, ex-professionals and pro-team doctors, he produces the ultimate manifesto for mature riders who want to stay healthy, avoid injury - and maximise their achievement levels. Time's arrow traditionally plots an incremental path into declining strength and speed for all of us. But we are different to every other generation of cyclists in human history. An ever-growing number of us are determined to scale the highest peaks of elite physical fitness into middle-age and beyond. Can the emerging medical and scientific research help us achieve the holy triumvirate of speed and health with age? The Midlife Cyclist offers a gold standard road-map for the mature cyclist who aims to train, perform and even race at the highest possible level.

With an introduction by author of The Tidal Zone, Sarah Moss

The Immortal Life of Henrietta Lacks is the true story behind the HBO film starring Oprah Winfrey and Rose Byrne.

Her name was Henrietta Lacks, but scientists know her as HeLa. Born a poor black tobacco farmer, her cancer cells – taken without her knowledge – became a multimillion-dollar industry and one of the most important tools in medicine. Yet Henrietta’s family did not learn of her ‘immortality’ until more than twenty years after her death, with devastating consequences . . .

Rebecca Skloot’s fascinating account is the story of the life, and afterlife, of one woman who changed the medical world for ever. Balancing the beauty and drama of scientific discovery with dark questions about who owns the stuff our bodies are made of, The Immortal Life of Henrietta Lacks is an extraordinary journey in search of the soul and story of a real woman, whose cells live on today in all four corners of the world.

For two decades, Understanding Clinical Papers has been helping students and professionals understand the research that supports evidence-based practice. Now in its fourth edition, this popular introductory textbook covers every major aspect of reading and evaluating clinical research literature, from identifying the aims and objectives of a paper to analysing the data with different multivariable methods. Numerous excerpts from actual clinical research papers make learning real and immediate, supported by a unique visual approach that reinforces key points and connects examples with the chapter material. The fourth edition includes extensively revised content throughout, including four brand-new chapters covering qualitative studies, Poisson regression, studies of complex interventions, and research using previously collected data. New and updated material discusses the difference between clinical and statistical significance, the consequences of multiple testing and methods of correction, how topic guides are used to explore and explain participants' experiences, standardised guidelines for writing trials and reviews, and much more. Offering clear explanations of important research-related topics, this reader-friendly resource: Offers a clear, concise, and accessible approach to learning how to read and analyse clinical research literature Features new coverage of qualitative research, including descriptive studies, sampling and populations, and identifying, summarising, and measuring qualitative characteristics Provides new material on missing data, sub-group analysis, feasibility and pilot studies, cluster randomised trials, and adaptive trial designs Includes new tables, abstracts, and excerpts from recent clinical research literature Understanding Clinical Papers is essential reading for all healthcare professionals and students, particularly those involved in clinical work and medical research, as well as general readers wanting to improve their understanding of research literature.

Tremendous growth in healthcare treatment techniques and methods has led to the emergence of numerous storage and communication problems and need for security among vendors and patients. This book brings together latest applications and state-of-the-art developments in healthcare sector using Blockchain technology. It explains how blockchain can enhance security, privacy, interoperability, and data accessibility including AI with blockchains, blockchains for medical imaging to supply chain management, and centralized management/clearing houses alongside DLT. Features: Includes theoretical concepts, empirical studies and detailed overview of various aspects related to development of healthcare applications from a reliable, trusted, and secure data transmission perspective. Provide insights on business applications of Blockchain, particularly in the healthcare sector. Explores how Blockchain can solve the transparency issues in the clinical research. Discusses AI with Blockchains, ranging from medical imaging to supply chain management. Reviews benchmark testing of AI with Blockchains and its impacts upon medical uses. This book aims at researchers and graduate students in healthcare information systems, computer and electrical engineering.

With the decade-long desire for optimum performance using biomaterials without additional surgery, replacement or maintenance, a desperate search is underway for tailoring the physical and physico-chemical properties of the materials surface and the biosystem.
This is the first book to concentrate on the highly important area of metal-based implants and their improved functionality and acceptance by the body. It thus focuses on the properties of biomaterial-tissue interfaces, which are discussed in terms of the biomaterials and the specific biological environments they are used in. Strong emphasis is placed on the recent results and success in improving the interface characterization towards implant refinement.
From the contents:
I. Interface Influence of Materials and Surface Modifications
* Passivity-inducing and -retaining Surfaces
* Topological Surface Modifications
* Chemical Surface Modifications
II. Physical and Physicochemical Surface Characterization
* Surface Topology
* Electrochemical Characterization
* Spectroscopic Interface Characterization
* Physical Characterization of Protein Adsorption
III. Biological Characterization of the Interface and Materials Related Biosystem Reactions
* Protein and Cell Adhesion Mechanisms
* Material-induced Cell Interactions
* Topology-dependent Cellular Interactions
* Materials-dependent Formation of New Hard Tissue

Key Features: 1. Describes the development of the randomized, controlled trial as the gold standard of proof. 2. Unravels the meaning of "randomized," "double-blind" and "p-values" in a simplified manner for students and clinicians. 3. Contains timeless information on how medical evidence can be understood.

The concepts of telemedicine and e-healthcare have eased as well as improved the reachability of experienced doctors and medical staff to remote patients. A patient who is living in a remote village area can directly connect to specialist doctors across the globe though his/her mobile phone using telemedicine systems and e-healthcare services. In pandemic situations like COVID-19, these online platforms helped society to get medical treatment from their residence without any physical movement. Technology is transforming human lives by playing an important role in the planning, designing, and development of intelligent systems for better service. This book presents a cross-disciplinary perspective on the concept of machine learning, blockchain and IoT by congregating cutting-edge research and insights. It also identifies and discusses various advanced technologies such as internet of things (IoT), big data analytics, machine learning, artificial intelligence, cyber security, cloud computing, sensors and so on that are vital to foster the development of smart healthcare and telemedicine systems by providing effective solutions to the medical challenges faced by humankind.

Contemporary Management of Metastatic Colorectal Cancer: A Precision Medicine Approach summarizes current knowledge and provides evidenced-based practice recommendations on how to treat patients with metastatic colorectal cancer. The book presents topics such as pre-operating imaging, the use of molecular markers in treatment decisions, neoadjuvant therapy, synchronous colorectal liver metastasis, and minimally invasive approaches. In addition, it discusses immunotherapy, targeted therapies and survivorship. This is a valuable resource for practitioners, cancer researchers, oncologists, graduate students and members of biomedical research who need to understand more about novel treatments for colorectal cancer metastasis.

Bioactive lipid metabolism and signaling are now widely accepted as major players in cancer biology. This volume helps to fill the urgent need to explore and investigate the innovations, current shortcomings, and future challenges of cancer therapy through the bioactive lipids by presenting new research on the use of bioactive lipids as effective weapons against cancer. The volume introduces the subject and then goes on to cover the chemistry, formulation, and mechanism of bioactive lipids in cancer. The volume takes a close look at lipoxins, ceramides, resolvins, and sphingosine-1-phosphate and their roles in cancer treatment. It also addresses the formulations based on bioactive lipids for the treatment of cancer. A variety of mechanisms of bioactive lipids as novel therapies are also covered, including using computational techniques to identify bioactive lipid drug targets, targeting therapy via KRAS and PI3K signals, and others. The authors also discuss the role and effects of various substances and their effect on various cancers, including colorectal cancer, prostate cancer, breast cancer, and others. The application of lysophosphatidic acid, lipopolysaccharide, lipid-soluble bioactive substance from avocado, omega-3 polyunsaturated fatty acids-derived lipid metabolites, and more are covered as well. The volume offers academia, technologists, and scientists from different disciplines valuable information to gain knowledge of bioactive lipid metabolism and signaling as an anti-cancer weapon in their fight against cancer.

Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion.
Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models.
Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.

Gives a convenient summary of trials in Gynecologic Oncology Supplies an invaluable revision primer for those undertaking certification Provides a uniquely up-to-date resource

Safely handle urine and body fluids | Process and analyze them effectively Here’s a comprehensive and highly visual introduction to the theoretical knowledge and practical skills needed to safely handle and analyze non-blood body fluids. The authors’ focused and reader-friendly approach begins with an emphasis on safety; introduces automation in urinalysis and body fluids analysis; and presents the foundational concepts of renal function and urinalysis. Then, step by step, you’ll learn the critical lab procedures for the examination of urine, cerebrospinal fluid, semen, synovial fluid, serous fluid, bronchoalveolar lavage fluid, amniotic fluid, feces, and vaginal secretions.

#10 on Amazon Charts, USA Today Bestseller "This book is my best attempt to tell the truth about my research, the culture in science today which is hostile to new ideas, and what science can really do if allowed to pursue promising areas of inquiries."-Dr. Judy Mikovits, PhD This is a story for anybody interested in the peril and promise of science at the very highest levels in our country. On July 22, 2009, a special meeting was held with twenty-four leading scientists at the National Institutes of Health to discuss early findings that a newly discovered retrovirus was linked to chronic fatigue syndrome (CFS), prostate cancer, lymphoma, and eventually neurodevelopmental disorders in children. When Dr. Judy Mikovits finished her presentation, the room was silent for a moment, then one of the scientists said, "Oh my God!" The resulting investigation would be like no other in science. For Dr. Mikovits, a twenty-year veteran of the National Cancer Institute, this was the midpoint of a five-year journey that would start with the founding of the Whittemore-Peterson Institute for Neuro-Immune Disease at the University of Nevada, Reno, and end with her as a witness for the federal government against her former employer, Harvey Whittemore, for illegal campaign contributions to Senate Majority Leader Harry Reid. On this journey Dr. Mikovits would face the scientific prejudices against CFS, wander into the minefield that is autism, and through it all struggle to maintain her faith in God and the profession to which she had dedicated her life.

Review of the First Edition: The authors strive to reduce theory to a minimum, which makes it a self-learning text that is comprehensible for biologists, physicians, etc. who lack an advanced mathematics background. Unlike in many other textbooks, R is not introduced with meaningless toy examples; instead the reader is taken by the hand and shown around some analyses, graphics, and simulations directly relating to meta-analysis... A useful hands-on guide for practitioners who want to familiarize themselves with the fundamentals of meta-analysis and get started without having to plough through theorems and proofs. -Journal of Applied Statistics Statistical Meta-Analysis with R and Stata, Second Edition provides a thorough presentation of statistical meta-analyses (MA) with step-by-step implementations using R/Stata. The authors develop analysis step by step using appropriate R/Stata functions, which enables readers to gain an understanding of meta-analysis methods and R/Stata implementation so that they can use these two popular software packages to analyze their own meta-data. Each chapter gives examples of real studies compiled from the literature. After presenting the data and necessary background for understanding the applications, various methods for analyzing meta-data are introduced. The authors then develop analysis code using the appropriate R/Stata packages and functions. What's New in the Second Edition: Adds Stata programs along with the R programs for meta-analysis Updates all the statistical meta-analyses with R/Stata programs Covers fixed-effects and random-effects MA, meta-regression, MA with rare-event, and MA-IPD vs MA-SS Adds five new chapters on multivariate MA, publication bias, missing data in MA, MA in evaluating diagnostic accuracy, and network MA Suitable as a graduate-level text for a meta-data analysis course, the book is also a valuable reference for practitioners and biostatisticians (even those with little or no experience in using R or Stata) in public health, medical research, governmental agencies, and the pharmaceutical industry.

The volume is comprehensively covers emerging technologies for health care, various aspects of biomedical research towards understanding of pathophysiology of the diseases, advances in improvement in diagnostic procedures and therapeutic tools, the fundamental role of biomedical research in the development of new medicinal products

This handbook provides an in-depth review of information across the developmental spectrum of gene and cell therapy products. From introductory information to state-of-the-art technologies and concepts, the book provides insights into upstream processes such as vector design and construction, purification, formulation and fill/finish as well as delivery options. Planning steps for compliance with current good manufacturing practice (CGMP) to readiness for chemistry, manufacturing, and controls (CMC) are also discussed.This book wraps up with examples of successes and pitfalls addressed by experts who have navigated the multiple challenges that are part of any innovative endeavor. Features Intended as a one-stop resource for availability of state-of-the-art information related to cell and gene therapy products for researchers, scientists, management and other academic and research institutions. Provides the most up to date information on the development of gene therapy, from the technology involved to gene correction and genome editing. Discusses siRNA, mRNA, and plasmid manufacturing. Describes the importance of supplier-sponsor synergies on the path to commercialization. Diverse audience with a large number of individuals in the core technologies and supportive practices.

The field of forensic arts therapies is dynamic and diverse, and so this unique volume covers a fascinating range of work. It brings together a collection of presentations given at FATAG conferences, case studies, research, new developments in theory, and explorations in the peculiarities of forensic arts therapies: art, music, drama, and dance. Therapists work with male and female offenders in detained in prisons or secure health care units, or sometimes with patients involved in probation or counselling services, victim support, and other services and institutions concerned with understanding the causes and effects of crime. The experiences described are often difficult, but also very rewarding for all involved. Arts therapy (in any of its forms) regularly has a profound and beneficial effect on the life of an offender. This thought-provoking and enlightening work gives an insight into how these skilled professionals have been a necessary part of UK forensic services for more than four decades.The Forensic Arts Therapies Advisory Group (FATAG) is a voluntary organisation which aims to provide support, advice and opportunities for continuing professional development for arts therapists working in forensic or secure settings and trainee arts therapists on clinical placement in forensics. FATAG provides a safe space to share difficult, complex and, at times, painful work not easily shared amongst a non-forensic audience.

The use of human subjects in biomedical research has increased rapidly with scientific discoveries. However, the failure to achieve the highest--or even adequate--standards of professional moral concern and behavior is a serious side effect. Research on Human Subjects is based on four years of intensive research in which two studies were completed--one on a nationally representative sample of biomedical research institutions, the second on a sample of 350 researchers who actually used human subjects. The authors explore prevalent ethical norms, the actual ethical behavior of scientists, and the dilemma between the values of humane therapy and scientific discovery. They document the inadequate training that biomedical researchers receive in the ethics of research on human subjects, not only in medical schools but in post-graduate training as well. This landmark work makes very specific suggestions for policy change and reform for the biomedical research profession and its employment of human subjects.

Give your patrons access to the digital content they need Electronic Resources in Medical Libraries is an essential guide to the challenges of acquiring, licensing, and managing the electronic access and use of books and journals. Medical librarians working in a variety of settings, including academic health centers, hospital libraries, and government health associations, provide entry-level, mid-career, and experienced librarians with comprehensive information and advice on dealing with electronic resources. This invaluable resource examines a wide range of issues, including collection development, pricing, open access, licensing, remote access, statistics, publisher liability, and the Semantic Web. As healthcare professionals, researchers, educators, and students rely more and more on digital content, medical libraries spend more and more time dealing with the complexities surrounding the use of e-resources. Electronic Resources in Medical Libraries examines the issues they face everyday, including the shift from print to electronic materials, off-campus and cross-campus access, usage statistics, journal pricing, open-access publishing, licensing, collection development, and much more. Topics addressed in Electronic Resources in Medical Libraries include: how to negotiate consortial packages how to use an electronic resource management (ERM) system how to create a portal to share electronic resources how to consolidate costs and provide wide access how open access affects pricing how to establish and maintain access to licensed e-resources how to develop a combined e-journal Web page how off-campus students interact with a full-service document delivery option for electronic journals how to integrate e-resources into an online catalog how to apply emerging Semantic Web technologies to digital libraries and much more Electronic Resources in Medical Libraries is an invaluable professional guide for medical and academic librarians, and a helpful classroom resource for faculty and students in library schools.

Covers the fundamentals of Machine Learning and Deep Learning in the context of healthcare applications Discusses various data collection approaches from various sources and how to use them in Machine Learning/Deep Learning models Integrates several aspects of AI-based Computational Intelligence like Machine Learning and Deep Learning from diversified perspectives which describe recent research trends and advanced topics in the field Explores the current and future impacts of pandemics and risk mitigation in healthcare with advanced analytics Emphazises feature selection as an important step in any accurate model simulation, ML/DL methods are used to help train the system and extract the positive solution implicitly

Unique and timely volume as mRNA is a hot area of research making great strides. Covers the full-scale production systems that are needed to develop vaccines as well as elements of data needed to secure the IND approvals. Introduces a commercial-scale manufacturing process using novel techniques like the PCR, in addition to the traditional plasmid DNA. First book that offers commercial technology for developing and large-scale supply of mRNA products. Renowned author and entrepreneur in the field of drug discovery and production.