Research physicians face intractable dilemmas when they consider introducing new medical procedures. Innovations carry the promise of preventing or curing life-threatening diseases, but they can also lead to injury or even death. How have clinical scientists made high-stakes decisions about undertaking human tests of new medical treatments? In "Lesser Harms," Sydney Halpern explores this issue as she examines vaccine trials in America during the early and mid-twentieth century.
Today's scientists follow federal guidelines for research on human subjects developed during the 1960s and 1970s. But long before these government regulations, medical investigators observed informal rules when conducting human research. They insisted that the dangers of natural disease should outweigh the risks of a medical intervention, and they struggled to accurately assess the relative hazards. Halpern explores this logic of risk in immunization controversies extending as far back as the eighteenth century. Then, focusing on the period between 1930 and 1960, she shows how research physicians and their sponsors debated the moral quandaries involved in moving vaccine use from the laboratory to the clinic.
This probing work vividly describes the efforts of clinical investigators to balance the benefits and dangers of untested vaccines, to respond to popular sentiment about medical hazards, and to strategically present risk laden research to sponsors and the public.
"Concise and extremely well-written. . . . A fascinating synthesis of sociology, history, and institutional theory."--Samuel C. Blackman, "Journal of the American Medical Association
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This manual is a comprehensive compilation of "methods that work" for deriving, characterizing, and differentiating hPSCs, written by the researchers who developed and tested the methods and use them every day in their laboratories. The manual is much more than a collection of recipes; it is intended to spark the interest of scientists in areas of stem cell biology that they may not have considered to be important to their work. The second edition of the"Human Stem Cell Manual"is an extraordinary laboratory guide for both experienced stem cell researchers and those just beginning to use stem cells in their work.
Offers a comprehensive guide for medical and biology researchers who want to use stem cells for basic research, disease modeling, drug development, and cell therapy applications.Provides a cohesive global view of the current state of stem cell research, with chapters written by pioneering stem cell researchers in Asia, Europe, and North America.Includes new chapters devoted to recently developed methods, such as iPSC technology, written by the scientists who made these breakthroughs."

A mixed model allows the incorporation of both fixed and random variables within a statistical analysis. This enables efficient inferences and more information to be gained from the data. The application of mixed models is an increasingly popular way of analysing medical data, particularly in the pharmaceutical industry. There have been many recent advances in mixed modelling, particularly regarding the software and applications. This new edition of a groundbreaking text discusses the latest developments, from updated SAS techniques to the increasingly wide range of applications. Presents an overview of the theory and applications of mixed models in medical research, including the latest developments and new sections on bioequivalence, cluster randomised trials and missing data. Easily accessible to practitioners in any area where mixed models are used, including medical statisticians and economists. Includes numerous examples using real data from medical and health research, and epidemiology, illustrated with SAS code and output. Features new version of SAS, including the procedure PROC GLIMMIX and an introduction to other available software. Supported by a website featuring computer code, data sets, and further material, available at: http: //www.chs.med.ed.ac.uk/phs/mixed/.

This much-anticipated second edition is ideal for applied statisticians working in medical research and the pharmaceutical industry, as well as teachers and students of statistics courses in mixed models. The text will also be of great value to a broad range of scientists, particularly those working the medical and pharmaceutical areas.

Now published in its Second Edition, the "Textbook of Clinical Trials" offers detailed coverage of trial methodology in diverse areas of medicine in a single comprehensive volume.

Praise for the First Edition:

.".". very useful as an introduction to clinical research, or for those planning specific studies within therapeutic or disease areas."" BRITISH JOURNAL OF SURGERY, Vol. 92, No. 2, February 2005

The book's main concept is to describe the impact of clinical trials on the practice of medicine. It separates the information by therapeutic area because the impact of clinical trials, the problems encountered, and the numbers of trials in existence vary tremendously from specialty to specialty. The sections provide a background to the disease area and general clinical trial methodology before concentrating on particular problems experienced in that area. Specific examples are used throughout to address these issues.

The "Textbook of Clinical Trials, Second Edition" Highlights the various ways clinical trials have influenced the practice of medicine in many therapeutic areasDescribes the challenges posed by those conducting clinical trials over a range of medical specialities and allied fieldsAdditional therapeutic areas are included in this Second Edition to fill gaps in the First Edition as the number and complexity of trials increases in this rapidly developing areaNewly covered or updated in the Second Edition: general surgery, plastic surgery, aesthetic surgery, palliative care, primary care, anaesthesia and pain, transfusion, wound healing, maternal and perinatal health, early termination, organ transplants, ophthalmology, epilepsy, infectious disease, neuro-oncology, adrenal, thyroid and urological cancers, as well as a chapter on the Cochrane networkAn invaluable resource for pharmaceutical companies, the "Textbook of Clinical Trials, Second Edition" appeals to those working in contract research organizations, medical departments and in the area of public health and health science alike.

The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically-relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up.

Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published.

Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, "Cardiovascular Clinical Trials: Putting the Evidence into Practice" Provides a succinct overview of recent major clinical trials - the gold standard for all medical treatment - across all the major cardiovascular subspecialties, to ensure you're up-to-date on the most critical findingsGuides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology, so you can conduct and/or appraise future trials yourselfAddresses methodology as well as clinical effectivenessOffers evidence-based assessments on the most effective treatments and authoritative clinical information on management of the conditions so you can confidently apply what you learn

Physicians, surgeons, specialist nurses - any clinician seeking an accessible resource for designing and conducting cardiovascular trials and then translating their results into practice will appreciate this book's clear guidance and succinct and practical approach.

Stanford's pioneering behavioral scientist draws on a lifetime of research and experience guiding the NIH to make the case that America needs to radically rethink its approach to health care if it wants to stop overspending and overprescribing and improve people's lives. American science produces the best-and most expensive-medical treatments in the world. Yet U.S. citizens lag behind their global peers in life expectancy and quality of life. Robert Kaplan brings together extensive data to make the case that health care priorities in the United States are sorely misplaced. America's medical system is invested in attacking disease, but not in addressing the social, behavioral, and environmental problems that engender disease in the first place. Medicine is important, but many Americans act as though it were all important. The United States stakes much of its health funding on the promise of high-tech diagnostics and miracle treatments, while ignoring strong evidence that many of the most significant pathways to health are nonmedical. Americans spend millions on drugs for high cholesterol, which increase life expectancy by only six to eight months on average. But they underfund education, which might extend life expectancy by as much as twelve years. Wars on infectious disease have paid off, but clinical trials for chronic conditions-costing billions-rarely confirm that new treatments extend life. Meanwhile, the National Institutes of Health spends just 3 percent of its budget on research on the social and behavioral determinants of health, even though these factors account for 50 percent of premature deaths. America's failure to take prevention seriously costs lives. More than Medicine argues that we need a shakeup in how we invest resources, and it offers a bold new vision for longer, healthier living.

This book, which is the second volume of Role of Microorganisms in Pathogenesis and Management of Autoimmune Diseases, provides comprehensive coverage on how microbial pathogens can subvert our immune system into responding against self and resulting in autoimmune diseases. In particular, the book covers the different aspects of linking gut microbiota dysbiosis with autoimmune mechanisms involved in disease development to identify future effective approaches based on the gut microbiota for preventing these autoimmune diseases.Contributions in the book focus on the role of microbiota/probiotics and their distinct mechanisms exerted in the management of autoimmune diseases of the kidney, central nervous system, eye, blood vessel, and bowel. This could help in better understanding to design of therapeutic strategies that can be deployed to prevent these autoimmune diseases.The book has an interdisciplinary appeal and scholars with an interest in immunology, medical microbiology, and nutritional sciences will value its contribution. Overall, the book gives new dimension and insight into the aspects of microbial role in autoimmune disease pathogenesis.

This volume of "Progress in Molecular Biology and Translational Science" discusses cutting-edge research of proteasomes and proteasome-associated proteins and cellular systems. The volume is split into two sections. The first part discusses the current knowledge of the structure, function, and regulation of the proteasomal system. The second part describes the role of the proteasome in aging and disease.

Key features:

* Contributions from leading authorities * Informs and updates on all the latest developments in the field

This volume of "Progress in Molecular Biology and Translational Science" covers the recent advances in the expanding fields of nutrigenetics and nutrigenomics. Forty authors from eight countries have contributed to the publication, representing the most cutting-edge research available.

Key features:

* Contributions from leading authorities * Informs and updates on all the latest developments in the field

Plants and other living organisms have great potential to treat human disease. There are two distinct types of biomedical research that seek to develop this potential. One type of research explores the value of medicinal plants as traditionally used andstudies of these plants have the potential to determine which plants are most potent, optimize dosages and dose forms, and identify safety risks. Another type of research uses bioassays to identify single molecules from plants that have interesting bioactivities in isolation and might be useful lead compounds for the development of pharmaceutical drugs.

This new volume of Advances in Botanical Research covers the recent trends in Medicinal Plants Research over 11 chapters. Topics that are covered include Development of Drugs from Plants - Regulation and Evaluation, Chinese Herbal Medicines for Rheumatoid Arthritis, and Taxol, camptothecin and beyond for cancer therapy.
Covers the recent trends in medicinal plants research over 11 chaptersTopics that are covered include Development of Drugs from Plants - Regulation and Evaluation, Chinese Herbal Medicines for Rheumatoid Arthritis, and Taxol, camptothecin and beyond for cancer therapy"

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 devicesto market. Because of timeline pressures and cost as well asthe 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 thisup-to-date, step-by-step guide book tobuilding and enhancingglobal clinical trial capacity inemerging markets anddeveloping countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to executesuch trials, appealing toindividuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials.

* Givesmedical professionals the businesstools needed to effectively execute clinical trials throughout the world

* Provides real world international examples which illustrate the practical translation of principles

* Includes forms, templates, and additional references for standardization in a number of global scenarios"

"Advances in Cancer Research" provides invaluable information on the exciting and fast-moving field of cancer research. Here, once again, outstanding and original reviews are presented on a variety of topics.
113th volume of Advances in Cancer ResearchExpert authorsChapters on topics including microRNA regulatory network, multifaceted oncoprotein tax, and underlying chromosomal translocations

This volume explores some of the most exciting recent advances in basic research on nanoparticles in translational science and medicine and how this knowledge is leading to advances in the various fields.
* This series provides a forum for discussion of new discoveries, approaches, and ideas
* Contributions from leading scholars and industry experts
* Reference guide for researchers involved in molecular biology and related fields

Tamoxifen Tales: Suggestions for Scientific Survival presents a case study describing the academic journey of teams behind major advances in medical sciences, highlighting lessons learned that are applicable to the next generation of scientists. This book provides a manual on the successful mentoring of young scientists, including stories describing how training experience shaped careers to become leaders in academia and the pharmaceutical industry. The book documents Professor V. Craig Jordan's 50-year career in medical sciences that led to the discovery and development of Selective Estrogen Receptor Modulators (SERMs), which became the standard of women's healthcare around the world. Additionally, it illustrates the versatility of a scientist with a commitment to serving societies. This important resource will be a useful and interesting book for established medical scientists, research mentors and advanced students wanting to chart a successful and impactful research career.

In the past several years, there has been an explosion in the ability of biologists, molecular biologists and biochemists to collect vast amounts of data on their systems. This volume presents sophisticated methods for estimating the thermodynamic parameters of specific protein-protein, protein-DNA and small molecule interactions. The use of thermodynamics in biological research is used as an energy book-keeping system. While the structure and function of a molecule is important, it is equally important to know what drives the energy force. These methods look to answer: What are the sources of energy that drive the function? Which of the pathways are of biological significance?

As the base of macromolecular structures continues to expand through powerful techniques of molecular biology, such as X-ray crystal data and spectroscopy methods, the importance of tested and reliable methods for answering these questions will continue to expand as well.

* Elucidates the relationships between structure and energetics and their applications to molecular design, aiding researchers in the design of medically important molecules * Provides a "must-have" methods volume that keeps MIE buyers and online subscribers up-to-date with the latest research * Offers step-by-step lab instructions, including necessary equipment, from a global research community "

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.

This book highlights the reasons for an urgently needed revision of the current global healthcare setup, discusses the needed mindset for a future of health, and provides a comprehensive development toolset for disruption (and for the needed incremental innovations towards disruption). Today's biomedical and health innovation related research in universities encourages activities that lead to incremental innovations with a relatively low risk of failure. The healthcare industry on the other hand provides tools and devices for established healthcare providers to improve the diagnosis and therapy/ treatment of the patients' health problems. The patient is not in the center of healthcare provision however, and prevention and prediction are not core goals. The current health setup needs to be challenged and disrupted. Disruptions are coming from technologies or processes that lead to a significant (>10x) reduction in cost or price/ performance and that also come with new business models. The need for change, effects of exponential technologies, and the needed shift to prevention and to homecare for health democratization and patient empowerment will be discussed in detail in the first parts of the book. The subsequent sections address several innovation methods with a focus on a novel meta methodology named Purpose Launchpad Health. This is followed by a comprehensive discussion on health entrepreneurship activities and needs. The final section of the book addresses how to train students to become entrepreneurial health innovators, presenting successful curricula and examples of health incubation and accelerator setups. All of the innovation tools presented and used in this book are summarized in the final chapter to help the reader get started planning an entrepreneurial venture. Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments. Chapters are concise and enriched with key messages, learning objectives and real innovation examples to bridge theory and practice. This book aims to serve as a teaching base for health innovation design and to prepare for health-related entrepreneurial ventures. Readers with medical, biomedical, biotechnology, and health economics backgrounds - and anyone who wants to become a future oriented health innovator or who believes in disruptive approaches - will find this book a useful resource and teaching tool for developing validated products/ services and processes for the future of health.

The combination of faster, more advanced computers and more quantitatively oriented biomedical researchers has recently yielded new and more precise methods for the analysis of biomedical data. These better analyses have enhanced the conclusions that can be drawn from biomedical data, and they have changed the way that experiments are designed and performed. This volume, along with the 2 previous "Computer Methods" volumes for the "Methods in Enzymology" serial, aims to inform biomedical researchers about recent applications of modern data analysis and simulation methods as applied to biomedical research.

* Presents step-by-step computer methods and discusses the techniques in detail to enable their implementation in solving a wide range of problems * Informs biomedical researchers of the modern data analysis methods that have developed alongside computer hardware *Presents methods at the "nuts and bolts" level to identify and resolve a problem and analyze what the results mean

In the past decades our understanding of stem cell biology has increased tremendously. Many types of stem cells have been discovered in tissues of which everyone presumed were unable to regenerate in adults; these include particularly the heart and the brain. There is vast interest in stem cells from biologists and clinicians who see the potential for regenerative medicine and future treatments for chronic diseases like Parkinson, diabetes and spinal cord lesions based on the use of stem cells and entrepreneurs in biotechnology who expect new commercial applications ranging from drug discovery to transplantation therapies.

As is often the case in science, many early claims turned out to be different from those expected. Embryonic stem cell therapies have not moved rapidly into clinical practice. Adult stem cells certainly have given certain degrees of success but not nearly to the extent that advocates would have wished for. Some claims of early successes in adult stem cell therapies have not been sustained in double-blinded, randomized clinical trials. Some claims are now close to routine therapy. Some of the claims not supported by evidence have nevertheless reached private clinical practice so that "stem cell tourism" is beginning to reach exaggerated proportions.

This book provides the reader background information on stem cells in a clear and well-organized manner. It provides the non-stem cell expert with an understandable review of the history, current state of affairs, and facts and fiction of the promises of stem cells. It distinguishes itself from the multiplicity of websites on the subject of stem cells by being scientifically, politically and ethically neutral, explaining pros and cons for stem cells of every sort with the intention of reaching a wide readership ranging from advanced students and patient advocacy groups to clinicians, specialists and early phase medics in training. By providing the background scientific and social information, it provides readers with the information they require to form their own opinions on the use of stem cells on the basis of facts rather than hype.

* Explains in straightforward, non-specialist language the basic biology of stem cells and their applications in modern medicine and future therapy

* Includes extensive coverage of adult and embryonic stem cells both historically and in contemporary practice

* Richly illustrated to assist in understanding how research is done and the current hurdles to clinical practice"

"Advances in Cancer Research" provides invaluable information on the exciting and fast-moving field of cancer research. Here, once again, outstanding and original reviews are presented on a variety of topics.

This volume comprehensively covers new technologies and methodologies that have appeared for the study of mouse development.

This volume is an update of volume 225 of MIE, "Guide to Techniques in Mouse Development," edited by P.M. Wassarman and M.L. DePamphilis and published in 1993. During the past 17 years many new technologies or methodologies have appeared for the study of mouse development and this volume comprehensively covers these, including: new techniques for the cryopreservation of gametes and embryos, production of transgenic and null (knockout) animals (use of ES cells), generation of conditional/inducible mutant animals, use of gene-trap mutagenesis, analysis of allele-specific expresion, use of new reporter constructs, humanizing of transgenic animals, transcript profiling of mouse development, imaging of mouse development, rederivation of animals and use of mouse genomics.

This volume comprehensively covers new technologies and methodologies that have appeared for the study of mouse development.

This volume is Part B of an update of volume 225, "Guide to Techniques in Mouse Development," edited by P.M. Wassarman and M.L. DePamphilis and published in 1993.

Comprehensively covers new techniques for the cryopreservation of gametes and embryos, production of transgenic and null (knockout) animals (use of ES cells), generation of conditional/inducible mutant animals, use of gene-trap mutagenesis, analysis of allele-specific expression, use of new reporter constructs, humanizing of transgenic animals, transcript profiling of mouse development, imaging of mouse development, and rederivation of animals and use of mouse genomics.

"Advances in Cancer Research" provides invaluable information on the exciting and fast-moving field of cancer research. Here, once again, outstanding and original reviews are presented on a variety of topics, including liposome-based chemotherapy and immunotherapy, human polyomaviruses, the role of micro RNAs in CLL, and cancer and cholesterol.

Virtual screening can reduce costs and increase hit rates for lead discovery by eliminating the need for robotics, reagent acquisition or production, and compound storage facilities. The increased robustness of computational algorithms and scoring functions, the availability of affordable computational power, and the potential for timely structural determination of target molecules, have provided new opportunities for virtual screening, and made it more practical. Why then, isn't everyone using virtual screening? Examining the scope and limitations of this method, Virtual Screening in Drug Discovery explores the algorithms involved and how to actually use them. Part I offers perspectives on both ligand-based and docking-based virtual screens. The authors of these chapters frame many of the challenges currently facing the field. Part II considers the choice of compounds that are best suited as drug leads. Part III discusses ligand-based approaches, including descriptor-based similarity, traditional pharmacophore searching, and similarity based 3D-pharmacophore fingerprints. The final two sections are devoted to molecular docking. Part IV outlines some important and practical considerations relating to the energetics of protein-ligand binding and target-site topography, whereas specific docking algorithms and strategies are discussed in Part V. Notwithstanding this list of subjects, the book does not overwhelm you with more information than you need-many of the strategies outlined will transcend the specifics of any given method. Nor does the book purport to offer single best ways to use the programs. What it does is provide a snapshot of virtual screening that gives you easy access to strategies and techniques for lead discovery. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug di

In recent years, the role of cilia in the study of health, development and disease has been increasingly clear and new discoveries have made this an exciting and important field of research. This comprehensive volume, a complement to the new three-volume treatment of cilia and flagella by King and Pazour, presents easy-to-follow protocols and detailed background information for researchers working with cilia and flagella.

*Covers protocols for primary cilia across several systems and species * Both classic and state-of-the-art methods readily adaptable across model systems, and designed to last the test of time * Relevant to clinicians and scientists working in in a wide range of fields