Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

Praise for the first edition: "Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book-not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

Learn how to evaluate and apply health sciences research with this beginner's guide! Reading Research: A User-Friendly Guide for Health Professionals, 7th Edition provides a clear introduction to reading and understanding research articles, with practical guidelines for implementing research into clinical practice. It describes how to interpret common research methods including qualitative, quantitative and mixed-method approaches, and explains how to find relevant, reliable research on the internet. Written by Barbara Davies and Jo Logan, both of whom are noted educators and research experts, this easy-to-use pocket guide is ideal for both students and health professionals. Concise overview of health sciences-related research maximizes your study time and makes it easier to understand qualitative, quantitative, and mixed-methods research. Succinct introduction to reading and understanding health sciences research articles is accompanied by practice worksheets and other learning resources on an Evolve website. Helpful guidelines suggest how to find interesting research results, identify how to use research results towards planning and delivering best practices and improving patient outcomes, and recommend actions to address barriers to using research in practice. UNIQUE! Tips boxes provide practical, easy-to-follow advice for those who are new to the subject. UNIQUE! Alert! boxes warn of common assumptions made when reading research. Recommendations for best practices in research include brief definitions of popular research terms as well as links to World Health Organization information, the latest RNAO (Registered Nurses' Association of Ontario) Best Practice Guidelines, and guidelines from Australia, the USA, the UK, and other countries. NEW! Enhanced worksheet exercises on the Evolve website demonstrate how to apply knowledge gained from the text, based on research articles drawn from Australia, Canada, Europe, and the USA, on a variety of health issues encountered in hospital and community settings.

In this volume, the major metabolic alterations identified in cancer and tumor-associated cells are explored, including discussions of former and emerging approaches to drug development in targeting cancer cell metabolism. The metabolic network in cells promotes the generation of both energy and biomass needed for them to grow, divide and differentiate. However, the metabolism of malignant cells generally varies from that of normal cells. These differences provide a platform for the discovery of new approaches to targeting potential vulnerabilities in cancer cells for therapeutic options Some of the significant changes that occur involve ATP production and consumption that modulates the ATP to ADP ratio, hypoxia and the effects of reactive oxygen species on glycolysis, regulation of mitochondrial respiration, induction and suppression of autophagy, and the Warburg effect and "reverse" Warburg effect--these topics and more are discussed in this volume.

The aim of this unique volume is to help medical researchers design clinical trials to improve survival, remission duration, or time to recurrence of disease. Written in a user-friendly step-by-step format, this work enables the researcher-with no background in statistics-to determine sample size and write statistical considerations for their protocols. It provides critical language which can help with FDA submissions and/or research grants. It also provides the mathematical justification of the material at a level consistent with one year of undergraduate mathematical statistics. It presents survival analysis methods at a more elementary level than any known text. Filled with tables, figures, plus an extensive appendix, this one-of-a-kind reference is an absolute must for all clinical researchers and biostatisticians.

The definitive "go to" text for Master's and Doctoral level courses on behavioral intervention research. It provides comprehensive coverage of the development, testing, and implementation of novel behavioral interventions in service and practice settings. This handbook provides comprehensive coverage of one of the most under-discussed and understood areas of public health research: developing, testing, and implementing novel behavioral interventions in service and practice settings. It examines the most critical issues related to behavioral intervention research in order to maximize the ability of intervention researchers to successfully implement current and future evidenced-based intervention protocols in targeted practice settings.

Participatory Visual Methodologies in Global Public Health focuses on the use of participatory visual methodologies such as photovoice, participatory video (including cellphilming or the use of cell phones to make videos), drawing and mapping in public health research. These approaches are modes of inquiry that can engage participants and communities, eliciting evidence about their own health and well-being, as well as modes of representation and modes of production in the co-creation of knowledge, and modes of dissemination in relation to knowledge translation and mobilization. Thus, the production by a group of girls or young women of a set of photos or videos from their own visual perspective can offer new evidence on how, for example, they see sexual violence. Unlike other data such as those collected through surveys or even conventional interviews, the images they have produced not only inform the empirical evidence, but also do not need to remain in a laboratory or the office of a researcher. They can, through exhibitions and screenings, reach various audiences: school or health personnel, parents and community members, and perhaps also policy-makers. This collection offers a critical overview for students, practitioners, researchers and policy-makers working in or concerned with the use of participatory methodologies in public health around the globe. This book was originally published as a special issue of Global Public Health.

One week, red wine is good for the heart. The next week, new reports say it's bad for the health. So which is true? Anyone who's ever read science news with fascination, or who's ever been confounded by conflicting stories will appreciate this book. Taking a look at some true to life contemporary news stories, the author assesses recent studies on topics ranging from vitamin C and caffeine to pollution and cancer. With straight talk and a passion for the whole project of science, he demysifies the cult of the expert and sheds light on the nitty-gritty details of scientific processes. Any scientist loves a challenge, but the biggest challenge of all, observes Jenkins, is shared by scientists and nonscientitsts alike: how to make practical decisions in light of ambiguous evidence. Promising no simple answers, this book does offer excellent food for thought for people pondering that next glass of wine.

This book provides a simplified, yet comprehensive, overview of the signalling pathways operating between and inside cells, which will help younger oncologists find their way in the labyrinth of signalling pathways and in the multitude of signals and signal receptors, transducers and effectors that contribute to oncogenesis. This comprehensive reference text is based on the master's courses delivered by Prof. Jacques Robert to graduate students at the University of Bordeaux, France. It includes a large number of colour schemas and figures that have been improved year after year for educational purposes. Signalling pathways are described individually and in depth, but without ignoring the multiplicity of interconnections and crosstalk. The presentation of each pathway is followed by a brief description of the alterations found in cancers as well as of the targeted pharmacological approaches that can be used to prevent or overcome the consequences of these oncogenic alterations. The basic mechanisms of molecular biology at the DNA replication, RNA transcription and protein activity levels are presented in a series of didactic annexes, enabling readers to better understand the alterations in signalling pathways.

2009 Choice Outstanding Academic Title 2009 Association of American University Presses Award for Jacket Design The stories of 70 women living in the aftermath of breast cancer Chemo brain. Fatigue. Chronic pain. Insomnia. Depression. These are just a few of the ongoing, debilitating symptoms that plague some breast-cancer survivors long after their treatments have officially ended. While there are hundreds of books about breast cancer, ranging from practical medical advice to inspirational stories of survivors, what has been missing until now is testimony from the thousands of women who continue to struggle with persistent health problems. After the Cure is a compelling read filled with fascinating portraits of more than seventy women who are living with the aftermath of breast cancer. Emily K. Abel is one of these women. She and her colleague, Saskia K. Subramanian, whose mother died of cancer, interviewed more than seventy breast cancer survivors who have suffered from post-treatment symptoms. Having heard repeatedly that "the problems are all in your head," many don't know where to turn for help. The doctors who now refuse to validate their symptoms are often the very ones they depended on to provide life-saving treatments. Sometimes family members who provided essential support through months of chemotherapy and radiation don't believe them. Their work lives, already disrupted by both cancer and its treatment, are further undermined by the lingering symptoms. And every symptom serves as a constant reminder of the trauma of diagnosis, the ordeal of treatment, and the specter of recurrence. Most narratives about surviving breast cancer end with the conclusion of chemotherapy and radiation, painting stereotypical portraits of triumphantly healthy survivors, women who not only survive but emerge better and stronger than before. Here, at last, survivors step out of the shadows and speak compellingly about their "real" stories, giving voice to the complicated, often painful realities of life after the cure. This book received funding from the Susan G. Komen Foundation.

This open access book is the outcome of a Global Forum on Innovation, Intellectual Property and Access to Medicines held in December 2019 at the Max Plank Instititute in Munich, organised by the South Centre and the Max Plank Institute. The academics and experts from international organisations participating have contributed chapters to this book. The book is for policy makers (in Ministries of Health, Ministries of Trade, Ministries of Foreign Affairs, patent offices), but also relevant for academics (law, trade, public health), on the flexibilities available in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization to promote access to medicines.

"Hox Genes: Methods and Protocols" explores techniques and methodologies which arose from or were successfully applied to the study of Hox genes and Hox proteins, at the intersection of experimental embryology, genetics, biochemistry, physiology, evolutionary biology and other life sciences. This detailed volume begins with a section on discovery and functional analysis of Hox genes and then it continues onward to discuss mode of action and biomedical applications of Hox proteins. Written in the highly successful "Methods in Molecular Biology" series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols and tips on troubleshooting and avoiding known pitfalls.

Expert and practical, "Hox Genes: Methods and Protocols" serves as an ideal guide to researchers striving to move forward in this dynamic and exciting area of study.

This book details the advances in drug discovery and delivery and the present need for emerging technologies. Throughout the text new micro and nanofabrication techniques are described, including methods like electrohydrodynamic processes, additive manufacturing, and microfluidics, which have the potential to produce drug delivery systems that were not possible a few years ago. This book is of great use to both entry-level and experienced researchers in the field of emerging technologies for the manufacturing of drug delivery devices.

Helping you become a creative, logical thinker and skillful "simulator," Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization. It presents the theories and methods needed to carry out computer simulations efficiently, covers both descriptive and pseudocode algorithms that provide the basis for implementation of the simulation methods, and illustrates real-world problems through case studies. The text first emphasizes the importance of analogy and simulation using examples from a variety of areas, before introducing general sampling methods and the different stages of drug development. It then focuses on simulation approaches based on game theory and the Markov decision process, simulations in classical and adaptive trials, and various challenges in clinical trial management and execution. The author goes on to cover prescription drug marketing strategies and brand planning, molecular design and simulation, computational systems biology and biological pathway simulation with Petri nets, and physiologically based pharmacokinetic modeling and pharmacodynamic models. The final chapter explores Monte Carlo computing techniques for statistical inference. This book offers a systematic treatment of computer simulation in drug development. It not only deals with the principles and methods of Monte Carlo simulation, but also the applications in drug development, such as statistical trial monitoring, prescription drug marketing, and molecular docking.

This book presents advanced expression technologies for the production of protein complexes. Since complexes lie at the heart of modern biology, the expression, purification, and characterization of large amounts of high-quality protein complexes is crucial for the fields of biomedicine, biotechnology, and structural biology. From co-expression in E. coli, yeast, mammalian and insect cells to complex reconstitution from individual subunits, this book offers useful insights and guidance for successful protein expressionists. Across several sections readers will discover existing opportunities for the production of protein complexes in bacterial systems (including membrane proteins and cell-free co-expression), methylotrophic and non-methylotrophic yeasts, protozoa (Leishmania terantolae and Dictyostelium discoideum), baculovirus-infected insect cells, mammalian cells, plants and algae. Complex reconstitution from individually purified subunits or subcomplexes is discussed as a complementary strategy. A last section introduces briefly some of the biophysical and structural characterization techniques for macromolecular complexes using state-of-the-art solution scattering and nuclear magnetic resonance. This work is a guided tour over some of the most powerful and successful protein expression technologies, with a focus on co-expression and high-throughput applications. It is addressed to everyone interested in the production and characterization of macromolecular complexes, from university students who want an accessible description of the major co-expression systems to researchers in biomedicine and the life sciences seeking for an up-to-date survey of available technologies.

Incidences of inflammatory airway diseases are on the rise across the world. Existing therapeutic options are ineffective, unsafe, and expensive, and severe cases are nonresponsive to conventional therapy. Therefore, it is imperative that research be undertaken to discover new treatment options. Obstructive Airway Diseases: Role of Lipid Mediators discusses clinically successful and potential lipid targets that can make a difference in treating some of the most intractable disease states. Topics discussed include: Obstructive airway diseases, etiology, pathophysiology, and existing therapeutic options What constitutes a lipid and how it is broken down to generate biologically active mediators The role of enzymes in the process of lipid mediator synthesis The biology of arachidonic acid, platelet-activating factor, and lysophosphatidic acid and the role they play in airway inflammation Products of arachidonic acid metabolism such as leukotrienes, prostaglandins, epieicosatrienoic acid, and oxoeicosatetraenoic acid Proresolution lipid mediators in inflammatory airway disease conditions The role of sphingosine and ceramide in inflammatory airway disease Protein kinases activated by lipid mediators and those that trigger the generation of lipid messengers The combined input of a panel of international authorities on lipid mediators makes this volume a valuable resource for all those involved in researching, teaching, and studying airway inflammation as well as those involved in drug discovery research. Punit Srivastava maintains a blog with additional information about the book and his work.

This book describes a novel and unique approach to the treatment of human diseases based on the study of natural animal models. A natural animal model is defined as an animal group or species that possesses a set of biochemical/physiological characteristics which are natural and adaptive for that animal, but are quite abnormal for humans. For example, how is it that birds can tolerate blood glucose concentrations which in humans are associated with diabetes. The natural animal model is living proof that a biological answer to this question is available. By studying natural animal models, we can gain valuable insights into the treatment of various human clinical disorders. Covering a wide range of disorders, this book describes in detail how medical scientists can take advantage of all the "research" that nature has already performed over billions of years in biological problem solving through extensive animal design testing and selection.

Many health professionals want to investigate their health care practice and how it could be improved to benefit their patients. This book introduces the range of research approaches available, and explains what can be achieved with different methods and how they can compliment each other. Research Methods for Health Care Practice guides the researcher through their journey, giving detailed, step-by-step advice on planning and carrying out each stage of the research. Useful examples from health care research are included throughout to illustrate the application of the techniques and methods discussed. The book provides discussion of all the key issues and stages of research, including: - user involvement in research - research ethics - deciding on a research approach - data collection and analysis methods Research Methods for Health Care Practice is ideal for professionals wanting to undertake research in their own health care setting, and will be of use to any students undertaking a research project as part of their course in health and related fields.

This book examines developments in qualitative psychotherapeutic research. It focuses on different methods and aspects of clinical practice. These range from the experiences of service users and clinicians, examining in detail different aspects of how therapy gets done in practice, to critiquing the politics and ideologies of psychotherapy practice. It aims to reflect the diversity that characterises this developing field and to represent practice-based research carried out in different clinical settings, from different perspectives and in different sociocultural contexts. The wide range of research projects presented arise from a network of clinicians and psychotherapy researchers who have established an international transdisciplinary forum for dedicated qualitative research on a range of topics in the field of mental health, using a variety of methodologies and theoretical approaches. In the spirit of dialogue, this book further provides chapters written by key practitioners in the field of qualitative research in mental health discussing these contributions. This book was originally published as a special issue of the European Journal of Psychotherapy & Counselling.

This book presents a state-of-the-art report on recent advances concerning Ganoderma and where the field is going. Although some older work is also cited, the main focus is on advances made over the past 20 years in the pharmacology and clinical applications of Ganoderma. Ganoderma lucidum (Lingzhi) has been used as a traditional medicine in Asian countries to maintain health and to treat diseases for more than two thousand years. Recently, its value has been demonstrated in preventing and treating certain diseases, such as tumors, liver disorders, renal injury, hypercholesterolemia, obesity, cerebral ischemia reperfusion, bronchitis etc. In addition, laboratory and clinical studies have confirmed that the chemical components of Ganoderma, such as Ganoderma lucidum polysaccharide peptides and triterpenes isolated from the fruiting body of Ganoderma lucidum, produce diverse pharmacological effects. Ganoderma and its components play an important part in antioxidant stress, radical-scavenging, immunomodulation, and intracellular signaling regulation, and accordingly warrant further study. This book systematically reviews the latest advances in our understanding of pharmacology and clinical applications of Ganoderma, and offers researchers and graduate students valuable new insights into the pharmacology and clinical applications of Ganoderma and related products.

Multiscale Fibrous Scaffolds in Regenerative Medicine, by Sowmya Srinivasan, R. Jayakumar, K. P. Chennazhi, Erica J. Levorson, Antonios G. Mikos and Shantikumar V. Nair; Stem Cells and Nanostructures for Advanced Tissue Regeneration, by Molamma P. Prabhakaran, J. Venugopal, Laleh Ghasemi-Mobarakeh, Dan Kai Guorui Jin and Seeram Ramakrishna; Creating Electrospun Nanofiber-Based Biomimetic Scaffolds for Bone Regeneration, by Eleni Katsanevakis, Xuejun Wen and Ning Zhang; Synthetic/Biopolymer Nanofibrous Composites as Dynamic Tissue Engineering Scaffolds, by J. A. Kluge and R. L. Mauck; Electrospun Fibers as Substrates for Peripheral Nerve Regeneration, by Jorg Mey, Gary Brook, Dorothee Hodde and Andreas Kriebel; Highly Aligned Polymer Nanofiber Structures: Fabrication and Applications in Tissue Engineering, by Vince Beachley, Eleni Katsanevakis, Ning Zhang, Xuejun Wen; Electrospinning of Biocompatible Polymers and Their Potentials in Biomedical Applications, by Pitt Supaphol, Orawan Suwantong, Pakakrong Sangsanoh, Sowmya Srinivasan, Rangasamy Jayakumar and Shantikumar V. Nair; Electrospun Nanofibrous Scaffolds-Current Status and Prospects in Drug Delivery, by M. Prabaharan, R. Jayakumar and S. V. Nair.; Biomedical Applications of Polymer/Silver Composite Nanofibers, by R. Jayakumar, M. Prabaharan, K. T. Shalumon, K. P. Chennazhi and S. V. Nair.-"

The second volume in the Wiley reference series in Biostatistics.

Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in:

• Bayesian methods
  
• Benefit/risk assessment
  
• Cost-effectiveness
  
• Ethics
  
• Fraud

Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials:

• Includes concise definitions and introductions to numerous concepts found in current literature

• Discusses the software and textbooks available

• Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts

As a truly translational area of biomedical investigation, epilepsy research spans an extraordinary breadth of subjects and involves virtually every tool that modern neuroscience has at its disposal. The Encyclopedia of Basic Epilepsy Research provides an up to date, comprehensive reference for all epilepsy researchers. With an expert list of authors, the encyclopedia covers the full spectrum of research activities from genes and molecules to animal models and human patients. The encyclopedia's electronic format also provides unparalleled access to frequent updates and additions, while the limited edition print version provides another option for owning this content. The Encyclopedia of Basic Epilepsy Research is an essential resource for researchers of all levels and clinicians who study epilepsy.
* The only comprehensive reference for basic research and current activities in epilepsy.
* Electronic format provides fast and easy access to updates and additions, with limited print version available as well.
* Contains over 85 articles, all written by experts in epilepsy research.

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.

This contributed volume gathers the latest knowledge in the field of stem cells in human reproductive organs, as well as animal models, and to consider the possibility of using this knowledge for clinical purposes. The scope of the book covers both clinical and basic knowledge of stem cells in both reproductive medicine (gynecology and obstetrics) and regenerative medicine as well as cellular and molecular medicine and reproductive biology. Chapters on basic stem cell knowledge in human reproductive tissues and organs or animal models are included, as well as clinical knowledge on their role in the manifestation of infertility and cancer and their clinical use.