As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region. Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.
Praise for the Second Edition: “...a grand feast for biostatisticians. It stands readyto satisfy the appetite of any pharmaceutical scientist with arespectable statistical appetite.” —Journal of ClinicalResearch Best Practices The Third Edition of Design and Analysis of ClinicalTrials provides complete, comprehensive, and expanded coverageof recent health treatments and interventions. Featuring a unifiedpresentation, the book provides a well-balanced summary of currentregulatory requirements and recently developed statistical methodsas well as an overview of the various designs and analyses that areutilized at different stages of clinical research and development.Additional features of this Third Edition include: • New chapters on biomarker development and targetclinical trials, adaptive design, trials for evaluating diagnosticdevices, statistical methods for translational medicine, andtraditional Chinese medicine • A balanced overview of current and emerging clinicalissues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrateeveryday applicability, with illustrations and examples to explainkey concepts • New sections on bridging studies and global trials, QTstudies, multinational trials, comparative effectiveness trials,and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical andscientific issues, statistical concepts, and methodologies forbridging clinical and statistical disciplines • An update of each chapter that reflects changes inregulatory requirements for the drug review and approval processand recent developments in statistical design and methodology forclinical research and development Design and Analysis of Clinical Trials, Third Editioncontinues to be an ideal clinical research reference for academic,pharmaceutical, medical, and regulatory scientists/researchers,statisticians, and graduate-level students.
Scholars and policymakers alike agree that innovation in the biosciences is key to future growth. The field continues to shift and expand, and it is certainly changing the way people live their lives in a variety of ways. With a large share of federal research dollars devoted to the biosciences, the field is just beginning to live up to its billing as a source of innovation, economic productivity and growth. Vast untapped potential to imagine and innovate exists in the biosciences given new tools now widely available. In The Biologist's Imagination, William Hoffman and Leo Furcht examine the history of innovation in the biosciences, tracing technological innovation from the late eighteenth century to the present and placing special emphasis on how and where technology evolves. Place is often key to innovation, from the early industrial age to the rise of the biotechnology industry in the second half of the twentieth century. The book uses the distinct history of bioinnovation to discuss current trends as they relate to medicine, agriculture, energy, industry, ecosystems, and climate. Fast-moving research fields like genomics, synthetic biology, stem cell research, neuroscience, bioautomation and bioprinting are accelerating these trends. Hoffman and Furcht argue that our system of bioscience innovation is itself in need of innovation. It needs to adapt to the massive changes brought about by converging technologies and the globalization of higher education, workforce skills, and entrepreneurship. The Biologist's Imagination is both a review of past models for bioscience innovation and a forward-looking, original argument for what future models should take into account.
Presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. Emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references.
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator’s biologic products. But scientific challenges remain due to the complexity of both the manufacturing process and the structures of biosimilar products. Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity and interchangeability of biosimilar products. It includes comparability tests of important quality attributes at critical stages of the manufacturing processes of biologic products. Connecting the pharmaceutical/biotechnology industry, government regulatory agencies, and academia, this state-of-the-art book focuses on the scientific factors and practical issues related to the design and analysis of biosimilar studies. It covers most of the statistical questions encountered in various study designs at different stages of research and development of biological products.
Sample size calculation plays an important role in clinical research. It is not uncommon, however, to observe discrepancies among study objectives (or hypotheses), study design, statistical analysis (or test statistic), and sample size calculation. Focusing on sample size calculation for studies conducted during the various phases of clinical research and development, Sample Size Calculation in Clinical Research explores the causes of discrepancies and how to avoid them. This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions. The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.
Author: Emily P. Wen,Ronald Ellis,Narahari S. Pujar
Publisher: John Wiley & Sons
Category: Technology & Engineering
Vaccine Manufacturing and Production is an invaluablereference on how to produce a vaccine - from beginning to end -addressing all classes of vaccines from aprocessing, production, and regulatory viewpoint. It willprovide comprehensive information on the various fields involved inthe production of vaccines, from fermentation, purification,formulation, to regulatory filing and facility designs. In recentyears, there have been tremendous advances in all aspects ofvaccine manufacturing. Improved technology and growth media havebeen developed for the production of cell culture with high celldensity or fermentation. Vaccine Manufacturing andProduction will serve as a reference on all aspects of vaccineproduction by providing an in-depth description of the availabletechnologies for making different types of vaccines and the currentthinking in facility designs and supply issues. This book willprovide insight to the issues scientists face when producing avaccine, the steps that are involved, and will serve asa reference tool regarding state-of-the-art vaccinemanufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a processpoint of view- fermentation to purification to formulationdevelopments; from a production point of view - from facilitydesign to manufacturing; and from a regulatory point of view -requirements from government agencies Authors from different major pharmaceutical and biotechnologycompanies Describes the challenges and issues involved in vaccineproduction and manufacturing of the different classes of vaccines,an area not covered by other books currently on the market
Supporting Professional Development through Collaborative Studies of Classroom Teaching with Technology
Author: Sara Hennessy
Publisher: Springer Science & Business Media
This book presents a fresh approach to bridging the perceived gap between academic and classroom cultures. It describes a unique form of research partnership whereby Cambridge University academics and school teachers together grappled with and reformulated theory – through in-depth case studies analysing practice using interactive whiteboards in five subject areas. The inquiry exploited the collaborators’ complementary professional knowledge bases. Teachers’ voices are particularly audible in co-authored case study chapters. Outcomes included deeper insights into concepts of sociocultural learning theory and classroom dialogue, more analytical mindsets, sustained new practices and ways of working collegially. The book reflects upon the power of lesson video review and details how the co-inquirers negotiated “intermediate theory” – bridging educational theory and specific settings – framed in mutually accessible language and embodied in interactive multimedia resources for teacher development. These include video clips, analytic commentary from multiple perspectives, lesson materials, plus optional prompts for reflection and critique – not models of “best practice”. The resources make pedagogy explicit and vividly illustrate the book’s ideas, offering theory-informed yet practical tools designed with and for practitioners. Hennessy and colleagues have tested a model of ongoing, teacher-led development and innovation, professional dialogue and classroom trialing stimulated by discussing selected multimedia resources. The book will interest academic and teacher researchers, initial teacher educators, professional development leaders, mentors, plus practitioners interested in using interactive whiteboards and dialogic teaching. It explores widening approaches to collegial development to reach educators working in other contexts (with and without technology). This could involve intermediate theory building or shortcutting by sharing and adapting the outcomes – springboarding teachers’ further critique and professional learning. “I cannot recommend this book too highly ... it weaves a complex developmental story with a range of facets. It emphasises clearly the rigour of the research that was conducted, while demonstrating the complexity of the inter-relationships, practices and issues for both teachers and researchers in developing practical and theoretical knowledge. Its graphic insights through text and associated media provide exemplars for teachers and those who work with teachers as a rich resource. It shows us all what can be achieved and the means of achieving it.” Prof. Barbara Jaworski, University of Loughborough
This book takes up the debate about matching vocational education with the labour market and shows progress in terms of theoretical models, tools (transformation and matching processes), and learning environments. The solutions, showing up the need for core or key skills, the necessity of embedding learning skills in authentic and guided learning environments, shows a perspective of research and developmen-tal work to be tested in schools and in workplaces, to find better curricula for a better skilling.
This book provides a hitherto unprecedented inside view on the European Commission - the institution, which substantially influences the legislative agenda of the European Union. The public usually views the Commission as a technocratic monolith. However, based on the testimony of 150 insiders, our systematic analyses show that the institution is internally ridden with political power struggles that affect the rules that govern Europe. It also provides newfirst-hand insights on some of the most contested policies of the EU's recent history, such as the European Research Council, Food labelling regulation or the Services Directive.
This reports details the findings of the full-scale studies on UV Disinfection Systems done in Austin, Orem and Atlanta. Coverage includes impact of common water treatment chemicals on UV disinfection, UV reactor performance modeling, a state's acceptance of UV technology. Findings discuss the use of native spore formers used an indicator of full-scale performance, the UCV systems inactivated all the human enteric viruses and no infections viruses were detected, the most prevalent virus in wastewater samples was adenovirus.
Robert A. Neimeyer,Darcy L. Harris,Howard R. Winokuer,Gordon F. Thornton
Author: Robert A. Neimeyer,Darcy L. Harris,Howard R. Winokuer,Gordon F. Thornton
Grief and Bereavement in Contemporary Society is an authoritative guide to the study of and work with major themes in bereavement. Its chapters synthesize the best of research-based conceptualization and clinical wisdom across 30 of the most important topics in the field. The volume’s contributors come from around the world, and their work reflects a level of cultural awareness of the diversity and universality of bereavement and its challenges that has rarely been approximated by other volumes. This is a readable, engaging, and comprehensive book that will share the most important scientific and applied work on the contemporary scene with a broad international audience, and as such, it will be an essential addition to anyone with a serious interest in death, dying, and bereavement.
H. Troidl,W.O. Spitzer,B. McPeek,D.S. Mulder,Martin F. Bach
Author: H. Troidl,W.O. Spitzer,B. McPeek,D.S. Mulder,Martin F. Bach
Publisher: Springer Science & Business Media
emerging on the surgical scene to challenge or For some readers, the title of this book will im thodoxy. Although these innovations are often mediately raise the question, what exactly is greeted with great optimism, a factual basis for meant by surgical research? In the very broadest that enthusiasm is sometimes far from secure sense the term can be taken to include all en and much further work is frequently required to deavors, however elementary or limited in discover whether we are dealing with genuine scope, to advance surgical knowledge. Ideally, advances or not. it refers to well-organized attempts to establish The most exciting and attractive scenario for on a proper scientific basis, i. e. , to place beyond surgical research is unquestionably one that de reasonable doubt, the truth or otherwise of any picts a successful attempt by a researcher to es concepts, old or new, within the ambit of sur gery, and, of course, anaesthesia. tablish the accuracy of some bold innovation for which he himself is responsible. Joseph Lister, The methods used to achieve that end vary demonstrating by clinical trial that wound sup enormously, depending on the issue being in vestigated.
Institute of Medicine,Committee on Community-Based Drug Treatment
Forging Partnerships with Community-Based Drug and Alcohol Treatment
Author: Institute of Medicine,Committee on Community-Based Drug Treatment
Publisher: National Academies Press
Today, most substance abuse treatment is administered by community-based organizations. If providers could readily incorporate the most recent advances in understanding the mechanisms of addiction and treatment, the treatment would be much more effective and efficient. The gap between research findings and everyday treatment practice represents an enormous missed opportunity at this exciting time in this field. Informed by real-life experiences in addiction treatment including workshops and site visits, Bridging the Gap Between Practice and Research examines why research remains remote from treatment and makes specific recommendations to community providers, federal and state agencies, and other decisionmakers. The book outlines concrete strategies for building and disseminating knowledge about addiction; for linking research, policy development, and everyday treatment implementation; and for helping drug treatment consumers become more informed advocates. In candid language, the committee discusses the policy barriers and the human attitudes--the stigma, suspicion, and skepticism--that often hinder progress in addiction treatment. The book identifies the obstacles to effective collaboration among the research, treatment, and policy sectors; evaluates models to address these barriers; and looks in detail at the issue from the perspective of the community-based provider and the researcher.
Here is a new book on methods and issues in clinical research. Its objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research. The book ends with a brief description of the drug development process and the phases of clinical development.
This book assists new and experienced scholars in planning and conducting high quality, contemporary studies for knowledge building about substance use. The target audience is individuals new to substance use as a field of study, either as novice researchers or as experienced researchers in other areas who find themselves lacking experience to address overlapping issues of substance use. Organized around a translational science framework, the contents address substance use research about epidemiology, etiology, intervention efficacy and effectiveness, and implementation of evidence-informed interventions. In addition, examples and issues are drawn from social work traditions involving multiple levels of study (organisms to large social systems), integrating biopsychosocial aspects, and adopting a lifespan perspective. The authors examine the implications for research of current "great debates" in the field and present readers with a variety of specific substance use research resources and tools. This practical "how to" guide takes the reader step-by-step through issues specific to substance use research in study design, participant recruitment and retention, measurement and analysis, and the processes involved in the dissemination, diffusion, and implementation of evidence-informed innovations. A variety of technical resources and measurement tools are provided, as are references to journals for scholars to consider both as knowledge resources and as outlets for disseminating their work. In sum, this book offers a fresh approach to conducting substance use research that is not readily available in other texts.
The European Union clearly matters for Civil Society Organizations (CSOs). EU officials and European political entrepreneurs has been crucial in the promotion of funding and access opportunities, but they have been proven to have little capacity to use CSOs for their own purposes.
Today, 166 million people in 18 countries lack access to adequate water resources, and it is estimated that by 2025, the number of people affected will increase to approximately three billion or 40 per cent of the worlds population. There is now an international consensus that the severity of the problem requires a strategic approach that emphasises the equitable and sustainable management of water resources. This report examines the implementation of the World Banks 1993 Water Resources Management policy and evaluates the effectiveness of strategies adopted which seek to address identified problems. It also makes recommendations for improving World Bank policy and strategy in the water sector.
The golden standard evaluation reference text Now in its second edition, Evaluation Theory, Models, andApplications is the vital text on evaluation models, perfectfor classroom use as a textbook, and as a professional evaluationreference. The book begins with an overview of the evaluation fieldand program evaluation standards, and proceeds to cover the mostwidely used evaluation approaches. With new evaluation designs andthe inclusion of the latest literature from the field, thisSecond Edition is an essential update for professionals andstudents who want to stay current. Understanding and choosingevaluation approaches is critical to many professions, andEvaluation Theory, Models, and Applications, Second Editionis the benchmark evaluation guide. Authors Daniel L. Stufflebeam and Chris L. S. Coryn, widelyconsidered experts in the evaluation field, introduce and describe23 program evaluation approaches, including, new to this edition,transformative evaluation, participatory evaluation, consumerfeedback, and meta-analysis. Evaluation Theory, Models, andApplications, Second Edition facilitates the process ofplanning, conducting, and assessing program evaluations. Thehighlighted evaluation approaches include: Experimental and quasi-experimental design evaluations Daniel L. Stufflebeam's CIPP Model Michael Scriven's Consumer-Oriented Evaluation Michael Patton's Utilization-Focused Evaluation Robert Stake's Responsive/Stakeholder-Centered Evaluation Case Study Evaluation Key readings listed at the end of each chapter direct readers tothe most important references for each topic. Learning objectives,review questions, student exercises, and instructor supportmaterials complete the collection of tools. Choosing fromevaluation approaches can be an overwhelming process, butEvaluation Theory, Models, and Applications, Second Editionupdates the core evaluation concepts with the latest research,making this complex field accessible in just one book.