"Summaries of papers" contained in the journal accompany each issue, 19--
Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs
Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.
Health care systems worldwide are faced with the challenge of improving the quality of care. Providing evidence from health research is necessary but not sufficient for the provision of optimal care and so knowledge translation (KT), the scientific study of methods for closing the knowledge-to-action gap and of the barriers and facilitators inherent in the process, is gaining significance. Knowledge Translation in Health Care explains how to use research findings to improve health care in real life, everyday situations. The authors define and describe knowledge translation, and outline strategies for successful knowledge translation in practice and policy making. The book is full of examples of how knowledge translation models work in closing the gap between evidence and action. Written by a team of authors closely involved in the development of knowledge translation this unique book aims to extend understanding and implementation worldwide. It is an introductory guide to an emerging hot topic in evidence-based care and essential for health policy makers, researchers, managers, clinicians and trainees.
Throughout history, physicians have played a vital role in medical discovery. These physician-scientists devote the majority of their professional effort to seeking new knowledge about health and disease through research and represent the entire continuum of biomedical investigation. They bring a unique perspective to their work and often base their scientific questions on the experience of caring for patients. Physician-scientists also effectively communicate between researchers in the "pure sciences" and practicing health care providers. Yet there has been growing concern in recent decades that, due to complex changes, physician-scientists are vanishing from the scene. In this book, leading physician-scientists and academic physicians examine the problem from a variety of perspectives: historical, demographic, scientific, cultural, sociological, and economic. They make valuable recommendations that—if heeded—should preserve and revitalize the community of physician-scientists as the profession continues to evolve and boundaries between doctors and researchers shift.
Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the "bench to bedside" translational approach to drug development. Clearly structured into three major parts, the book stakes out the boundaries of peptide drug development in the preclinical as well as clinical stages. The first part provides a general background and focuses on the characteristic strengths and weaknesses of peptide drugs. The second section contains five cases studies of peptides from diverse therapeutic fields, and the lessons to be learned from them, while the final part looks at new targets and opportunities, discussing several drug targets and diseases for which peptide drugs are currently being developed.
Mixed Methods in Health Sciences Research: A Practical Primer, by Leslie Curry and Marcella Nunez-Smith, presents key theories, concepts, and approaches in an accessible way. Packed with illustrations from the health sciences literature, this ready-to-use guidebook shows readers how to design, conduct, review, and use mixed methods research findings. Helpful checklists, figures, tables, templates, and much more give readers examples that will elevate the quality of their research, facilitate communication about their methods, and improve efficiency over the course of their projects. Real-world examples and insights from mixed methods researchers provide unique perspectives on every aspect of mixed methods research. This book successfully pulls together foundational mixed methods principles, synthesizes the knowledge base in the field, and translates it for a health science researcher audience. “The content is highly applicable to real life research teams in the areas of clinical research, health services research, and implementation science, providing sound content and practical advice. The authors have synthesized and pull key concepts from a variety of sources to provide a concise resource.” —Linda M. Herrick, South Dakota State University “Everything from the references, to the topics, checklists, conceptual graphic representations, and organizers, interviews, and resources, all contribute to the content and aid with understanding and/or application. … It addresses specific MM research as it pertains to health sciences in a way that other texts just do not even attempt.” —Denise L. Winsor, University of Memphis “[This text is] a very pragmatic approach to mixed methods research; excellent resources, tables, and figures [are] provided, along with cases and examples of value to researchers and grant reviewers. Its relevance to practice, education, and research, as well as to potential policy implications, is a strong focus that would make this a valued textbook for any researcher!” ? —Karen Devereaux Melillo, University of Massachusetts Lowell “The text is cutting edge. It leads the way with its focus on team dynamics. [The authors] succeed in making the book relevant and practical. They also articulate a number of key insights in the area of mixed methods that rarely get addressed, such as teams and conflict. Great read with a lot of good, practical information for mixed methods researchers at all levels. The practical approach of this text makes it an innovative and valuable resource.” —John G. Schumacher, University of Maryland
2012 First Place AJN Book of the Year Award Winner in Nursing Research! "This is a resource for success and should be a part of any researcher's library."--Doody's Medical Reviews This book is a practical, user-friendly guide for health care researchers across multiple disciplines who are involved in intervention research. It provides all of the essential elements needed for understanding how to design, conduct, analyze, and fund intervention studies that are replicable and can withstand the scrutiny of the Institutional Review Board and peer review. Developed from an annual continuing education workshop on intervention studies conducted by Dr. Melnyk, this text is the most comprehensive body of information available on this topic. Contributors address the design of interventions that are ethically considerate and sensitive to culture, race/ethnicity, and gender, minimizing threats to external and internal validity, measurement, and budgeting. The guide explores such implementation issues as subject recruitment and retention, data management, and specialized settings, cost analysis, and explaining intervention effects. The text also guides readers in writing grant applications that fund , and addresses how to move intervention study findings into the real world. A unique addition to the book is the availability of digital examples of progress reports, final reports, and research grant applications that have received funding from the National Institutes of Health and other relevant organizations. This text is a valuable resource for all health care professionals conducting research and for doctoral students in health care studies. Key Features: Presents the essential tools for designing, conducting, analyzing, and funding intervention studies Designed for use by health care professionals conducting intervention research Provides comprehensive, accessible guidelines for doctoral students across all health care disciplines Instructs readers on writing grant applications that fund Includes digital examples of funded research grants, progress reports, and final reports
A guide to state-of-the-art cancer immunotherapy in translational cancer research A volume in the Translational Oncology series, Immunotherapy in Translational Cancer Research explores the recent developments in the role that immunotherapy plays in the treatment of a wide range of cancers. The editors present key concepts, illustrative examples, and suggest alternative strategies in order to achieve individualized targeted therapy. Comprehensive in scope, Immunotherapy in Translational Cancer Research reviews the relevant history, current state, and the future of burgeoning cancer-fighting therapies. The book also includes critical information on drug development, clinical trials, and governmental resources and regulatory issues. Each chapter is created to feature: development of the immunotherapy; challenges that have been overcome in order to scale up and undertake clinical trials; and clinical experience and application of research. This authoritative volume is edited by a team of noted experts from MD Anderson Cancer Center, the world’s foremost cancer research and care center and: Offers a comprehensive presentation of state-of-the-art cancer immunotherapy research that accelerates the pace of clinical cancer care Filled with the concepts, examples, and approaches for developing individualized therapy Explores the breath of treatments that reflect the complexity of the immune system itself Includes contributions from a panel international experts in the field of immunotherapy Designed for physicians, medical students, scientists, pharmaceutical executives, public health and public policy government leaders and community oncologists, this essential resource offers a guide to the bidirectional interaction between laboratory and clinic immunotherapy cancer research.
|Author||: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation|
|Publisher||: National Academies Press|
|Release Date||: 2010-10-22|
|ISBN 10||: 9780309163354|
|Pages||: 150 pages|
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Learn rigorous statistical methods to ensure valid clinicaltrials This Second Edition of the critically hailed Clinical Trials buildson the text's reputation as a straightforward and authoritativepresentation of statistical methods for clinical trials. Readersare introduced to the fundamentals of design for various types ofclinical trials and then skillfully guided through the completeprocess of planning the experiment, assembling a study cohort,assessing data, and reporting results. Throughout the process, theauthor alerts readers to problems that may arise during the courseof the trial and provides commonsense solutions. The author bases the revisions and updates on his own classroomexperience, as well as feedback from students, instructors, andmedical and statistical professionals involved in clinical trials.The Second Edition greatly expands its coverage, ranging fromstatistical principles to controversial topics, includingalternative medicine and ethics. At the same time, it offers morepragmatic advice for issues such as selecting outcomes, samplesize, analysis, reporting, and handling allegations of misconduct.Readers familiar with the First Edition will discover completelynew chapters, including: * Contexts for clinical trials * Statistical perspectives * Translational clinical trials * Dose-finding and dose-ranging designs Each chapter is accompanied by a summary to reinforce the keypoints. Revised discussion questions stimulate critical thinkingand help readers understand how they can apply their newfoundknowledge, and updated references are provided to direct readers tothe most recent literature. This text distinguishes itself with its accessible and broadcoverage of statistical design methods--the crucial building blocksof clinical trials and medical research. Readers learn to conductclinical trials that produce valid qualitative results backed byrigorous statistical methods.
This practical guide briefly covers the historical and epidemiological background of palliative care and the growth of palliative medicine as a specialty, before dealing with major physical, psychological, spiritual, and symptom management issues from diagnosis to bereavement care.
|Author||: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation|
|Publisher||: National Academies Press|
|Release Date||: 2012-09-13|
|ISBN 10||: 0309253187|
|Pages||: 248 pages|
There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.
Developing a Program of Research offers the first practical guide on creating, evolving and sustaining a successful program of research in applied health, social sciences, and education fields. Discover how accomplished researchers from a variety of disciplines developed their programs built interdisciplinary networks, and worked with decision-makers to maximize their research impact. Learn how to navigate the key roles and structures of research institutes, and develop an understanding of the role and context of funding agencies. Enriched with practical exercises, international case studies and thought-provoking questions, this is the essential guide for anyone who's exploring--or revisiting--the challenging and rewarding process of developing a research program. An indispensable resource for early- and mid-career researchers, Developing a Program of Research also holds invaluable information for established researchers seeking to shifting their focus--as well as for mentors and educators of early-career researchers, and leaders of organizational research units, centres, and institutes. Filled with insights from established and experienced researchers, this book serves as both a practical handbook and a behind-the-scenes look at how to develop a program of research.
|Author||: Chap T. Le|
|Publisher||: John Wiley & Sons|
|Release Date||: 2010|
|ISBN 10||: 0470371307|
|Pages||: 399 pages|
An updated treatment of categorical data analysis in the biomedical sciences that now explores applications to translational research Thoroughly updated with the latest advances in the field, Applied Categorical Data Analysis and Translational Research, Second Edition maintains the accessible style of its predecessor while also exploring the importance of translational research as it relates to basic scientific findings within clinical practice. With its easy–to–follow style, updated coverage of major methodologies, and broadened scope of coverage, this new edition provides an accessible guide to statistical methods involving categorical data and the steps to their application in problem solving in the biomedical sciences. Delving even further into the applied direction, this update offers many real–world examples from biomedicine, epidemiology, and public health along with detailed case studies taken straight from modern research in these fields. Additional features of the Second Edition include: A new chapter on the relationship between translational research and categorical data, focusing on design study, bioassay, and Phase I and Phase II clinical trials A new chapter on categorical data and diagnostic medicine, with coverage of the diagnostic process, prevalence surveys, the ROC function and ROC curve, and important statistical considerations A revised chapter on logistic regression models featuring an updated treatment of simple and multiple regression analysis An added section on quantal bioassays Each chapter features updated and new exercise sets along with numerous graphs that demonstrate the highly visual nature of the topic. A related Web site features the book′s examples as well as additional data sets that can be worked with using SAS® software. The only book of its kind to provide balanced coverage of methods for both categorical data and translational research, Applied Categorical Data Analysis and Translational Research, Second Edition is an excellent book for courses on applied statistics and biostatistics at the upper–undergraduate and graduate levels. It is also a valuable reference for researchers and practitioners in the biomedical and public health fields.
|Author||: Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer|
|Publisher||: Academic Press|
|Release Date||: 2015-03-13|
|ISBN 10||: 012417146X|
|Pages||: 716 pages|
The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes