Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

Carrier testing of adults provides information about the risk of passing a genetic mutation to your children, leading to reproductive (and some say, eugenic) decisions. Excessive carrier screening may have adverse effects, but it can also prevent suffering and open up new reproductive options. Raz's study focuses on the interplay of community genetics (the medical organisation of carrier screening) and genetic alliances (networks of individuals at risk), exploring how 'genetic communities' are emerging both within existing ethnic groups and around patients' organizations.

While the interplay between carrier testing, reproduction and eugenics has sparked many discussions, this study provides a novel and much-needed perspective on its actual implementation and interpretation by community members. Conflating a cross-cultural spectrum of genetic communities, the benefits and perils of supporting (or restricting) carrier screening are located within broader social issues such as religion, ethnicity, multi-culturalism, abortion, stigmatization, suffering and care-giving. While carrier screening emerges as ultimately a morally justified pronatalist endeavour for the reduction of suffering, thus being different in principle from the 'old' eugenics, it can also carry unintended adverse consequences if left unattended to consumers, communities, or health professionals.

This book explores the recent advances in the techniques and platforms used in biomarker research that have revolutionized the way we study, diagnose, and treat brain injury conditions. The contributors describe different biomarker studies pertaining to brain injury and other neurological disorders and analyze the different models and technologies used to identify these biological markers. The book includes findings from "Omics research" that have been utilized to decipher and identify such biomarkers. It discusses protein, microRNA, and altered gene profiles and reviews neurological disorders such as multiple sclerosis, Charcot-Marie-Tooth disease, and prion and Alzheimer's disease.

Cloning, embryo research and genetic modification are three of the most controversial issues of our time. Is it ethical to use cloning as a means of reproduction? Are embryos people? Is there a difference between removing genetic disease and creating « designer babies? This book will attempt to show that these and other problems are ultimately resolvable, given careful and unbiased application of established ethical principles, many of which underlie common morality. These principles, when applied to the problems of the new genetic technologies, form the basis of a new genetic morality. This book applies established principles of biomedical ethics to the new genetic technologies and examines the ethical implications of reproductive and therapeutic cloning, genetic modification and stem cell research from a deontological and a rule-utilitarian perspective. Finally, it seeks to establish what, if anything, is wrong with each of these practices, and why.

There exists today a fast growing availability of personal genetic information. Its prognostic impact and value for an individual or family member's health is sometimes unclear, whilst at other times it is clear-cut. The issue of whether to disclose genetic information does however have wide ranging implications. Avoiding the rhetoric of 'genetic exceptionalism', and drawing on an expanded field of bioethical, sociological and anthropological research, this book sets a new agenda for discussing the ethics surrounding the disclosure of prognostic genetic information. A hermeneutical approach reconsiders the ethics of disclosure in a variety of contexts in which genetic information is generated, requested, interpreted or communicated - from the provider perspective, but also from the moral perspectives of clients and their families. It is in situations of disclosure, in these different contexts, that genetic information meets morality. Providers and recipients can become vulnerable to the revelation or concealment of information, and the forms in which it may be provided. Disclosure Dilemmas invites readers to explore these contexts from an ethical viewpoint and will be a valuable resource for anyone with an interest in biomedical ethics.

Dr. Anjali Aggarwal is working as a Senior Scientist at National Dairy Research Institute, Karnal (India). She holds a PhD degree in Animal Physiology and is involved in research and teaching at post-graduate level. Her area of research work is stress and environmental physiology. She has more than 50 publications, two technical bulletins, four manuals and many book chapters to her credit. She has successfully guided many post-graduate and PhD students. Her major research accomplishments are on microclimatic modification for alleviation of heat and cold stress, mist and fan cooling systems for cows and buffaloes, and use of wallowing tank in buffaloes. Her work involves the use of technology of supplementing micronutrients during dry period and early lactation to crossbred and indigenous cows for alleviating metabolic and oxidative stress and improved health and productivity. Studies are also done in her lab on partitioning of heat loss from skin and pulmonary system of cattle and buffaloes as a result of exercise or exposure to heat stress. Dr. R.C. Upadhyay is working as Head, Dairy Cattle Physiology Division at National Dairy Research Institute, Karnal (India). He graduated in Veterinary Sciences and obtained his PhD degree in Animal Physiology. His area of recent research is climate change, stress, and environmental physiology. His major research accomplishment is on climate change impact assessment of milk production and growth in livestock. His work also involves studying methane conversion and emission factors for Indian livestock and use of IPCC methodology of methane inventory of Indian livestock. Heat shock protein-70 expression studies in cattle and buffaloes are also done in his lab. Draught animal power evaluation, fatigue assessment, work-rest cycle and work limiting factors form the highlights of his work. Studies on partitioning of heat loss from skin and pulmonary system of cattle and buffaloes and electrocardiographic studies in cattle, buffalo, sheep and goat are also undertaken in his lab. He has more than 75 research papers, four books and several book chapters to his credit. Technologies developed and research done by him include methodology of methane measurement: open and closed circuit for cattle and buffaloes; inventory of methane emission from livestock using IPCC methodology; livestock stress index: thermal stress measurement based on physiological functions; and draught power evaluation system and large animal treadmill system. He received training in Radio-nuclides in medicine at Australian School of Nuclear Technology, Lucas heights, NSW, Australia in 1985 and Use of radioisotopes in cardiovascular investigations at CSIRO, Prospect, NSW, Australia, during 1985-86. He has guided several post-graduate and PhD students. He is recipient of Hari Om Ashram Award-1990 (ICAR) for outstanding research in animal sciences.

This volume investigates human genetic biobanking and its regulation in various Asian countries and areas, including Japan, Mainland China, Taiwan, Hong Kong, India and Indonesia.. It sheds light on how cultural, socio-political and economic factors influence the set-up of bioethical regulation for human genetic biobanks and how bioethical sensitivities surrounding biobanks are handled.

Apart from placing discourses of trust in an international perspective, the comparative materials presented in this volume also put into perspective the concepts of genetic theft and exploitation, and genetic wealth and trust. This collection contains case studies of biobanking practices in societies with different needs and welfare levels, and provides insights into government strategies towards genetic resources by examining bioethics as practised at home.

Pocket Guide to Gene Level Diagnostics in Clinical Practice is an abbreviated, pocket-size, quick-reference guide that provides a point-by-point synopsis of the vast wealth of information contained in CRC Handbook of Gene Level Diagnostics in Clinical Practice. All sections and subsections in the Pocket Guide are cross-referenced to corresponding pages in the Handbook. The book works well on its own as a quick reference, but also can be used in conjunction with the larger Handbook for detailed coverage and references to specific information. Pocket Guide to Gene Level Diagnostics in Clinical Practice also includes extensive supplements featuring material not included in the Handbook. These are intended to provide an up-dated, practical source of information useful to anyone involved in molecular diagnostic research and/or service. Supplements are cross-referenced to the main text of the Pocket Guide, that complement and enhance the material covered. Pocket Guide to Gene Level Diagnostics in Clinical Practice will be a handy reference for professionals and students in pathology, biotechnology, biology, and medicine.

Psychiatric genetics has become 'Big Biology'. This may come as a surprising development to those familiar with its controversial history. From eugenic origins and contentious twin studies to a global network of laboratories employing high-throughput genetic and genomic technologies, biological research on psychiatric disorders has become an international, multidisciplinary assemblage of massive data resources. How did psychiatric genetics achieve this scale? How is it socially and epistemically organized? And how do scientists experience this politics of scale? Psychiatric Genetics: From Hereditary Madness to Big Biology develops a sociological approach of exploring the origins of psychiatric genetics by tracing several distinct styles of scientific reasoning that coalesced at the beginning of the twentieth century. These styles of reasoning reveal, among other things, a range of practices that maintain an extraordinary stability in the face of radical criticism, internal tensions and scientific disappointments. The book draws on a variety of methods and materials to explore these claims. Combining genealogical analysis of historical literature, rhetorical analysis of scientific review articles, interviews with scientists, ethnographic observations of laboratory practices and international conferences, this book offers a comprehensive and detailed exploration of both local and global changes in the field of psychiatric genetics.

The Handbook provides an essential resource at the interface of Genomics, Health and Society, and forms a crucial research tool for both new students and established scholars across biomedicine and social sciences. Building from and extending the first Routledge Handbook of Genetics and Society, the book offers a comprehensive introduction to pivotal themes within the field, an overview of the current state of the art knowledge on genomics, science and society, and an outline of emerging areas of research. Key themes addressed include the way genomic based DNA technologies have become incorporated into diverse arenas of clinical practice and research whilst also extending beyond the clinic; the role of genomics in contemporary 'bioeconomies'; how challenges in the governance of medical genomics can both reconfigure and stabilise regulatory processes and jurisdictional boundaries; how questions of diversity and justice are situated across different national and transnational terrains of genomic research; and how genomics informs - and is shaped by - developments in fields such as epigenetics, synthetic biology, stem cell, microbial and animal model research. Chapter 13 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://www.routledgehandbooks.com/doi/10.4324/9781315451695-13 Chapter 28 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://www.routledgehandbooks.com/doi/10.4324/9781315451695-28

Two to three decades ago, multiple primary malignancies (MPM) were considered to be simply a clinical curiosity, with sporadic reports, mostly single case descriptions, found in the literature. While in the last few years, analyses of larger series have been published, the number of cases has still been relatively small and most of the reports have addressed a single type of primary tumor and its associations. With the improved prognosis and survival of cancer patients, MPM is becoming increasingly prevalent in this population, necessitating a better understanding of the characteristics and associations of the malignancies involved. Thus, as a prerequisite, a universal definition and an internationally accepted classification system, based on chronological, pathological, clinical, and other parameters, are needed. Moreover, much remains to be learned about the etiology of MPM, whether genetic, iatrogenic, or environmental. Several of the hereditary syndromes, such as familial adenomatous polyposis, hereditary non-polyposis colorectal cancer, hereditary breast-ovarian cancer, and multiple endocrine neoplasia, are already well-known and their characteristics in relation to MPM must be kept in mind. Nonetheless, along with these syndromes, there are sporadic and apparently casual associations between primary neoplasms that can involve almost any part of the body. This volume points out the clinical aspects of MPM and discusses the diagnostic and therapeutic problems that are encountered in treating these patients. "DNA-guided" surgery, currently confined to the treatment of patients with hereditary syndromes, will, along with other novel treatment strategies, no doubt play an increasingly greater role in the therapy of MPM. This work presents state-of-the-art information about MPM that is aimed at a broad range of medical specialists, including surgeons, endoscopists, oncologists, and geneticists, . The goal is to improve our understan

The controversial topic of the technology of Pre-implantation Genetic Diagnosis, and the muddled approach to this subject adopted by the UK Parliament, is explored in detail in this volume. The author takes the viewpoint that the HFEA has taken insufficient notice to date of certain core ethical principles and makes the case for a much more ethically consistent and humane system than has been managed so far.

Arguing that many of the fears and objections levied against Robert Nozick's notion of the 'Genetic Supermarket' by disability activists, christian bioethicists and radical feminists, amongst others, are internally inconsistent, philosophically unsound or merely highly improbable, the author considers a number of individual policy decisions of the HFEA and addresses such questions as:

• Can a case be made out for state involvement in such decisions?
• Who stands to be harmed by a supermarket model?
• Are any ethical principles or societal interests threatened by it?

This book is an essential resource for law students of all levels and professionals working within or interested in medical and healthcare law and medical genetics.

The controversial topic of the technology of Pre-implantation Genetic Diagnosis, and the muddled approach to this subject adopted by the UK Parliament, is explored in detail in this volume. The author takes the viewpoint that the HFEA has taken insufficient notice to date of certain core ethical principles and makes the case for a much more ethically consistent and humane system than has been managed so far.

Arguing that many of the fears and objections levied against Robert Nozick's notion of the 'Genetic Supermarket' by disability activists, christian bioethicists and radical feminists, amongst others, are internally inconsistent, philosophically unsound or merely highly improbable, the author considers a number of individual policy decisions of the HFEA and addresses such questions as:

• Can a case be made out for state involvement in such decisions?
• Who stands to be harmed by a supermarket model?
• Are any ethical principles or societal interests threatened by it?

This book is an essential resource for law students of all levels and professionals working within or interested in medical and healthcare law and medical genetics.

The availability of human genome, large amount of data on individual genetic variations, environmental interactions, influence of lifestyle, and cutting-edge tools and technologies for big-data analysis have led to the era of clinical practice of "Precision Medicine". This book aims to provide a readily available resource on all the important developments achieved so far in the field of oncology. All recent developments have been explained along with epidemiology, technologies and approaches to manage the included diseases. Therefore, readers will get the up to date information on the next-generation approach in tackling all kinds of cancer. Key Features * Presents the latest trend of cancer management based on precision/predictive medicine approach * Reviews the latest and up to date literature in the field of Precision Medicine * Highlights the next generation approach in tackling malignant diseases * Discusses how a life-threatening disease like cancer can be managed with the help of Precision Medicine * Encapsulates a global prospective

This second edition is fully updated throughout and covers the emerging evidence that indicates that the Gadd45 family of proteins plays a unique and critical role as sensors of stress, including genotoxic, physiological, and oncogenic stress. It sheds light on the complex cellular stress response, encompassing myriad molecular pathways with a plethora of regulators and effectors. The GADD45 stress response genes encode small (18 kd) nuclear/cytoplasmic proteins. These genes are rapidly induced by a wide variety of endogenous and exogenous stress stimuli. Despite marked similarities, Gadd45 genes are regulated differentially and exhibit functional diversity. Gadd45 proteins respond to physiological and oncogenic stress, and are implicated in cell cycle arrest, DNA demethylation and repair, apoptosis, cell survival, genomic stability, and inflammation. The purpose of this book is to provide a comprehensive overview of the unique global role that Gadd45 proteins play as stress sensors and the molecular pathways involved.

During the past two decades, our understanding of the molecular genetics of inherited eye diseases, their classification, and management has undergone a huge expansion as the field of human genetics has benefited from technological advances and increased interest by physicians and scientists in all fields. As a result, the amount of clinical and basic-science information on inherited systemic and eye diseases has become so large that general ophthalmologists, ophthalmic subspecialists, and physicians in other fields have found it difficult to keep up. This volume will act as a guide because it catalogues all the latest information about genetic diseases that involve the eye and presents it in a practical and accessible format. After an introductory chapter that reviews basic clinical and molecular-genetic principles, individual diseases and groups of diseases are listed alphabetically in order to make it as easy as possible to search for an entry. The material in each entry is a synthesis of numerous articles and reviews on the topic, accompanied by at least one high-quality illustration, at least one webpage of a patient support group or other organization related to the disease, and references that provide the original description of the disease, an excellent review, or useful illustrations. There is also a companion website containing electronic copies of all the illustrations to make it easy to use them in lectures. Health-care professionals who need immediate access to clinical and basic-science information on inherited systemic and eye diseases will find this volume indispensable.

Unique in its focus on this particular field of cardiovascular science, Molecular Mechanisms of Cardiac Hypertrophy and Failure reviews current knowledge of the mechanisms contributing to heart failure.Bringing together an internationally renowned team of contributors, the text provides expert reviews on the latest advances in molecular and cell biology, biochemistry and pharmacology. scientists in academia and industry, the book has particular emphasis on the following key areas: - cardiac hypertrophy - contractile depression - arrhythmogenesis - genetics - the clinical implications of the research in these areas. interest to clinical cardiologists, vascular medicine specialists, hematologists, and internists, as well as members of the cardiovascular research community and pharmaceutical and biotechnology industries.

The discovery of the two inherited susceptibility genes BRCA1 and BRCA2 in the mid-1990s created the possibility of predictive genetic testing and led to the establishment of specific medical programmes for those at high risk of developing breast cancer in the UK, US and Europe. The book provides a coherent structure for examining the diversity of practices and discourses that surround developments linked to BRCA genetics, and to the evolving field of genetics more broadly. It will be of interest to students and scholars of anthropology, sociology, history of science, STS, public health and bioethics. Chapter 8 of this book is freely available as a downloadable Open Access PDF under a Creative Commons Attribution-Non Commercial-No Derivatives 3.0 license. https://s3-us-west-2.amazonaws.com/tandfbis/rt-files/docs/Open+Access+Chapters/9780415824064_oachapter8.pdf

Research into DNA and the development of powerful techniques to produce DNA profiles enable experts to appear in court and give compelling. scientific evidence in many types of case. This book gives the legal practitioner a complete account of the issues involved in taking DNA evidence into court. It helps lawyers to ask important and probing questions when faced with such evidence in court. This second edition has been thoroughly updated to take account of recent legislation and case law.

Epigenetics is defined as heritable changes that do not affect the DNA sequence but influence gene expression. Epigenetic changes occur at the levels of DNA, histone, protein, and chromatin structures. Proper epigenetic modifications are essential for cell differentiation and function during development, while some epigenetic modifications are passed on from parents to offspring through gametes. Therefore, alterations of epigenetic states would have serious consequences for human development and health. This realization and the advent of new technologies have encouraged the advance of epigenetic studies in recent years. Nonetheless, many aspects of epigenetics, such as regulatory mechanisms and evolutional advantages, remain to be better understood.Written by 26 scientists at the forefront of epigenetics research, this book discusses the different facets of epigenetics: from gametogenesis to child development, as well as from mechanistic studies in animal models to reviews of human clinical data.

The volume is collection of articles treating the topic of human improvement/enhancement from a variety of perspectives - philosophical, literary, medical, genetic, sociological, legal etc. The chapters in this volume treat not only those aspects that most immediately come to mind when one thinks of 'human enhancement', such as genetic engineering, cloning, artificial implants and artificial intelligence etc. Somewhat less obvious aspects include evolutionary perspectives in connection with the prolongation of the human lifespan, plastic surgery since its beginnings, and questions such as whether the distinction between 'natural' and 'artificial' can really be drawn at all and how it has been conceived across the ages, or what the legal implications are of recent developments and techniques. Many papers make links to the representation of these developments in popular culture, from Jules Verne through Aldous Huxley to the movie Gattaca, address the hopes and fears that come with them as well as the question how realistic these are. While all chapters are written by scientists at the international top of their respective fields, all are accessible to a non-specialist audience and eminently readable. We believe that they represent a state-of-the art overview of questions that are of interest to a large audience. The book thus targets a non-specialist audience with an interest in philosophical, sociological, scientific and legal issues involved in both traditional and recent matters concerning the desire of mankind to improve itself, the human body, the human mind and the human condition. It is unique in that it brings together all these aspects within a coherent and cohesive collection.

Over the past few years there has been a proliferation of genetic databases and biobanks, which promise to increase scientists' understandings of the way our genes interact with the environment. These biomedical research projects involve hundreds of thousands of people worldwide who are asked to donate blood and tissue samples as well as personal information. The control, exploitation and ownership of such detailed personal medical information by governments and by commercial companies is generating social and ethical controversy. contradictions and limitations of the current regulatory frameworks for and policy debates about genetic databases. Drawing on original empirical research and theoretical debates in the fields of sociology, anthropology and legal studies, the contributors to this book challenge the prevailing orthodoxy of informed consent and explore the relationship between personal privacy and the public good. They also consider the multiple meanings attached to human tissue and the role of public consultations and commercial involvement in the creation and use of genetic databases. representation of participation that is often at odds with the experiences and understandings of those taking part. The findings present a serious challenge for public policy to provide mechanisms to safeguard the welfare of individuals participating in genetic databases. The book is written in an accessible style that will appeal to a multidisciplinary and international audience, and is relevant to policy discussions in Europe and in North America, as well as other countries that are developing similar initiatives. It will be of great interest to academics and students of medical sociology, health studies, public health, public policy and ethics.

Over the past few years there has been a proliferation of genetic databases and biobanks, which promise to increase scientists' understandings of the way our genes interact with the environment. These biomedical research projects involve hundreds of thousands of people worldwide who are asked to donate blood and tissue samples as well as personal information. The control, exploitation and ownership of such detailed personal medical information by governments and by commercial companies is generating social and ethical controversy. Genetic Databases offers a timely analysis of the underlying tensions, contradictions and limitations of the current regulatory frameworks for and policy debates about genetic databases. Drawing on original empirical research and theoretical debates in the fields of sociology, anthropology and legal studies, the contributors to this book challenge the prevailing orthodoxy of informed consent and explore the relationship between personal privacy and the public good. They also consider the multiple meanings attached to human tissue and the role of public consultations and commercial involvement in the creation and use of genetic databases. The authors argue

This book is dedicated to those who died of malignant hyperthermia and to their families. It contains cases studies that would be helpful for anesthesiologists, surgeons, physiologists, molecular biologists, biophysicists, biochemists, pathologists, students, and post doctoral fellows.

Omics is an emerging and exciting area in the field of science and medicine. Numerous promising developments have been elucidated using omics (including genomics, transcriptomics, epigenomics, proteomics, metabolomics, interactomics, cytomics and bioinformatics) in cancer research. The development of high-throughput technologies that permit the solution of deciphering cancer from higher dimensionality will provide a knowledge base which changes the face of cancer understanding and therapeutics.

This is the first book to provide such a comprehensive coverage of a rapidly evolving area written by leading experts in the field of omics. It complies and details cutting-edge cancer research that covers the broad advances in the field and its application from cancer-associated gene discovery to drug target validation. It also highlights the potential of using integration approach for cancer research.

This unique and timely book provides a thorough overview of developing omics, which will appeal to anyone involved in cancer research. It will be a useful reference book for graduate students of different subjects (medicine, biology, engineering, etc) and senior scientists interested in the fascinating area of advanced technologies in cancer research.

Readership: This is a precious book for all types of readers cancer researchers, oncologists, pathologists, biologists, clinical chemists, pharmacologists, pharmaceutical specialists, biostatisticians, and bioinformaticists who want to expand their knowledge in cancer research."