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Global Clinical Trials Playbook

Global Clinical Trials Playbook
  • Author : Menghis Bairu,Richard Chin
  • Publisher :Unknown
  • Release Date :2012-06-12
  • Total pages :320
  • ISBN : 9780124158603
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Summary : 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 devices to market. Because of timeline pressures and cost as well as the 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 this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools 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

Global clinical trials playbook : management and implementation when resources are limited

Global clinical trials playbook : management and implementation when resources are limited
  • Author : Menghis Bairu,Richard Yoonsik Chin
  • Publisher :Unknown
  • Release Date :2012
  • Total pages :229
  • ISBN : OCLC:1132121848
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Summary : 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 devices to market. Because of timeline pressures and cost as well as the 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 this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials

Global Clinical Trials

Global Clinical Trials
  • Author : Richard Chin,Menghis Bairu
  • Publisher :Unknown
  • Release Date :2011-05-06
  • Total pages :522
  • ISBN : 012381538X
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Summary : This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA

Global Clinical Trials for Alzheimer's Disease

Global Clinical Trials for Alzheimer's Disease
  • Author : Menghis Bairu,Michael Weiner
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780124115309
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Summary : Global Clinical Trials for Alzheimer’s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer’s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer’s disease. Written by leading experts with hands-on experience in designing and running global Alzheimer’s disease and other neurodegenerative diseases clinical trials A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer’s disease global clinical trials in emerging markets and developing countries

Global Clinical Trials for Alzheimer’s Disease

Global Clinical Trials for Alzheimer’s Disease
  • Author : Yağız Üresin,Hilal İlbars,İbrahim Hakan Gürvit,Murat Emre
  • Publisher :Unknown
  • Release Date :2013-08-28
  • Total pages :432
  • ISBN : 9780128070529
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Summary : Turkey straddles the continents of Europe and Asia, and this unique geographical location steers its economy. On the world economic scale, as an exceptional emerging economy, Turkey is the 16th largest economy in the world and the sixth largest economy as compared with the European Union countries, according to gross domestic product. The Turkish pharmaceutical sector is ranked 16th in terms of market value, and it is 36th in terms of the clinical research conducted and the volume of pharmaceutical exports. Investments by foreign companies have increased since 1984 and 19 foreign capital firms have entered the Turkish pharmaceuticals market since 1990. Today, there are approximately 300 entities operating in Turkey. Turkey has a long tradition of providing clinical trial legislation, regulation and guidelines; the country has taken major steps towards harmonizing its legislation with those of the European Union in the field of clinical research. Currently Turkish regulations are completely in line with EC Directives. Clinical trials performed in the field of Alzheimer’s disease in Turkey since 1997, including their rationale, design, summary, and outcomes, are discussed in this chapter.

A Comprehensive and Practical Guide to Clinical Trials

A Comprehensive and Practical Guide to Clinical Trials
  • Author : Delva Shamley,Brenda Wright
  • Publisher :Unknown
  • Release Date :2017-06-07
  • Total pages :210
  • ISBN : 9780128047309
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Summary : A Comprehensive and Practical Guide to Clinical Trials provides an overview of the entire process of clinical research in one thorough and easy-to-read handbook that offers those involved in clinical research a clear understanding of how the components of a study are related. It focuses on the practical aspects of the preparation and execution of a clinical trial and offers tools and resources to help the entire team understand how their responsibilities tie together with the tasks and duties of other members. This allows for better planning and prioritization, and can lead to more effective and successful clinical trials. With practical examples, checklists and forms, this book is a useful guide for planning and conducting clinical trials from beginning to end. Describes the entire clinical trial management process from start to finish in a step-by-step guide Provides best practice elements, including case studies, practical examples, activities, and checklists Accompanied by a website with PowerPoint slides and an image bank

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
  • Author : Richard Chin,Bruce Y Lee
  • Publisher :Unknown
  • Release Date :2008-07-25
  • Total pages :560
  • ISBN : 0080557937
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Summary : Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results. Jargon-free writing style enables those with less experience to run their own clinical trials and interpret data Book contains an ideal mix of theory and practice so researchers will understand both the rationale and logistics to clinical trial medicine Expert authorship whose experience includes running clinical trials in an academic as well as industry settings Numerous illustrations reinforce and elucidate key concepts and add to the book's overall pedagogy

Bad Science

Bad Science
  • Author : Ben Goldacre
  • Publisher :Unknown
  • Release Date :2010-10-12
  • Total pages :304
  • ISBN : 9780771035760
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Summary : The informative and witty expose of the "bad science" we are all subjected to, called "one of the essential reads of the year" by New Scientist. We are obsessed with our health. And yet — from the media's "world-expert microbiologist" with a mail-order Ph.D. in his garden shed laboratory, and via multiple health scares and miracle cures — we are constantly bombarded with inaccurate, contradictory, and sometimes even misleading information. Until now. Ben Goldacre masterfully dismantles the questionable science behind some of the great drug trials, court cases, and missed opportunities of our time, but he also goes further: out of the bullshit, he shows us the fascinating story of how we know what we know, and gives us the tools to uncover bad science for ourselves. From the Hardcover edition.

Cytokine Storm Syndrome

Cytokine Storm Syndrome
  • Author : Randy Q. Cron,Edward M. Behrens
  • Publisher :Unknown
  • Release Date :2019-09-09
  • Total pages :617
  • ISBN : 9783030220945
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Summary : Cytokine Storm Syndromes, including HLH and MAS, are frequently fatal disorders, particularly if not recognized early and treated during presentation. The genetics of Cytokine Storm Syndromes are being defined with many of the risk alleles giving rise to mutations in the perforin-mediated cytolytic pathway used by CD8 cytotoxic T cells and natural killer cells. These are being studied using murine models. Up to 10% of the general population may carry risk alleles for developing Cytokine Storm Syndromes, and Cytokine Storm Syndromes are being increasingly recognized around the world in pediatric and adult hospitals. A variety of infectious, rheumatic, and oncologic triggers are commonly associated with Cytokine Storm Syndromes, but understanding this disorder is critical for all researchers and physicians to ensure timely and appropriate therapy. This textbook, the first of its kind, addresses all aspects of the disorder – from genetics, pathophysiology, and ongoing research, to clinical presentations, risk factors, and treatment.

Confronting Covid-19: A Strategic Playbook for Leaders and Decision Makers

Confronting Covid-19: A Strategic Playbook for Leaders and Decision Makers
  • Author : Devadas Krishnadas
  • Publisher :Unknown
  • Release Date :2020-10-30
  • Total pages :229
  • ISBN : 9789814928489
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Summary : COVID-19 is the most challenging crisis the world has faced for almost a century. As a truly global pandemic, there is not a single country on earth – or even a single person – immune to the economic, political and social impact of the devastating virus. This book analyses the coronavirus crisis in unparalleled depth. The author begins in section one by framing the COVID-19 pandemic by categorically identifying variables and factors central to understanding how COVID-19 has panned out. This is followed in section two with an examination of the pandemic in the realms of politics, public health and economics .Section three comprises in-depth country case studies, complete with scenario mapping and a formulation of recommendations, before section four looks beyond the immediate imperatives of the ongoing pandemic and pictures our shared future in a 'post-Covid' world. Confronting COVID-19's combination of rigorous, evidence-based analyses, projections and actionable recommendations makes this a must-read book for all leaders and decision makers in public, private and community sectors. Most of all, the ideas presented within these pages command the urgent attention of those within the international policy-making community.

The Online Advertising Playbook

The Online Advertising Playbook
  • Author : Joe Plummer,Stephen D. Rappaport,Taddy Hall,Robert Barocci
  • Publisher :Unknown
  • Release Date :2007-07-20
  • Total pages :320
  • ISBN : 0470140356
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Summary : Praise for The Online Advertising Playbook "Finally, someone has documented all we know about online advertising and how to do it right. As much as this confirms that online advertising really works, we know that marketers don't always get it right. The ARF's The Online Advertising Playbook provides critical insight on what sticks and what doesn't in online advertising and marketing." —Greg Stuart, CEO and President, Interactive Advertising Bureau and coauthor of What Sticks "The Online Advertising Playbook's principles, case studies, and strategic insights equip marketers with the best knowledge available. It will help your online advertising achieve the full range of marketing objectives, from lead generation and customer acquisition to driving trial and loyalty." —Tim Kopp, Vice President, Global Interactive Marketing, The Coca-Cola Company "To grow interactive marketing from here we need to institutionalize our wisdom and experience about what works. This book explains, in a disciplined way, what marketers have learned from a decade of massive change." —Ted McConnell, Interactive Innovation Director, Procter & Gamble "The Online Advertising Playbook is a milestone in the maturation of interactive advertising, but also an invaluable go-to guide for managers trying to make smart decisions with their advertising budgets." —Van Riley, Vice President of Research, AOL "The best marketing communication is spawned from what I call 'informed intuition.' After reading The Online Advertising Playbook, I am far better informed on how to optimize the online channel in our advertising and promotional programs. It's a perfect blend of case studies and research-backed learning." —Rod DeVar, Manager, Advertising and Promotion, United States Postal Service "Savvy marketers should take advantage of The Online Advertising Playbook's findings and principles to get real results." —Chris Theodoros, Director of Industry Relations, Google "A work of wisdom and rigor in the digital space that is as relevant for the newbie as it is for the digerati." —Mike Donahue, Executive Vice President, American Association of Advertising Agencies "This is a must-read for any marketing executive involved in online advertising. It's high time that a book looks at online advertising in the context of an integrative promotional strategy, one meant to set objectives, establish creative strategies, and measure results. The book nicely ties the various components of online advertising to relevant case studies, and the emphasis on measurement and results is refreshing. Not only is it relevant for marketing executives, it would also be a good basic text for any Internet advertising course and a good adjunct to any Internet marketing course." —Henry Assael, Professor of Marketing, Stern School of Business, New York University

Data and Safety Monitoring Committees in Clinical Trials

Data and Safety Monitoring Committees in Clinical Trials
  • Author : Jay Herson
  • Publisher :Unknown
  • Release Date :2016-12-19
  • Total pages :241
  • ISBN : 9781498784122
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Summary : 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.

Social and Interpersonal Dynamics in Pain

Social and Interpersonal Dynamics in Pain
  • Author : Tine Vervoort,Kai Karos,Zina Trost,Kenneth M. Prkachin
  • Publisher :Unknown
  • Release Date :2018-07-18
  • Total pages :532
  • ISBN : 9783319783406
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Summary : This groundbreaking analysis moves our knowledge of pain and its effects from the biomedical model to one accounting for its complex psychosocial dimensions. Starting with its facial and physical display, pain is shown in its manifold social contexts—in the lifespan, in a family unit, expressed by a member of a gender and/or race—and as observed by others. These observations by caregivers and family are shown as vital to the social dynamic of pain—as observers react to sufferers’ pain, and as these reactions affect those suffering. The book’s findings should enhance practitioners’ understanding of pain to develop more effective individualized treatments for clients’ pain experience, and inspire researchers as well. Among the topics covered: Why do we care? Evolutionary mechanisms in the social dimension of pain. When, how, and why do we express pain? On the overlap between physical and social pain. Facing others in pain: why context matters. Caregiving impact upon sufferers’ cognitive functioning. Targeting individual and interpersonal processes in therapeutic interventions for chronic pain. Social and Interpersonal Dynamics in Pain will be a valuable resource for clinicians who deal in pain practice and management, as well as for students and researchers interested in the social, interpersonal, and emotional variables that contribute to pain, the processes with which pain is associated, and the psychology of pain in general.

The Importance of Pharmacovigilance

The Importance of Pharmacovigilance
  • Author : World Health Organization
  • Publisher :Unknown
  • Release Date :2002-01-01
  • Total pages :48
  • ISBN : 9241590157
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Summary : The purpose of this document is to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
  • Author : Agency for Healthcare Research and Quality/AHRQ
  • Publisher :Unknown
  • Release Date :2014-04-01
  • Total pages :356
  • ISBN : 9781587634338
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Summary : This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Adaptive and Flexible Clinical Trials

Adaptive and Flexible Clinical Trials
  • Author : Richard Chin
  • Publisher :Unknown
  • Release Date :2016-04-19
  • Total pages :198
  • ISBN : 9781439838334
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Summary : Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial. This often results in studies that are substantially faster, more efficient, and more powerful. Recent developments in web-based real-time data entry and advances in statistical methods have made adaptive clinical trials much more popular because they have become both more practical and attractive. However, there is paucity of resources that explain the mathematical framework and the practical considerations for adaptive designs without the use of highly technical statistical jargon. Suitable for readers in academia, industry, and government involved in drug development, Adaptive and Flexible Clinical Trials is the first book that comprehensively explains all essential aspects of adaptive clinical trials. Written in an easy-to-understand style aimed at clinicians and other non-statisticians, this book focuses not on the statistical details, but rather on the application of statistical concepts for adaptive clinical trials. Utilizing concrete examples, the book thoroughly explains the design, conduct, and analysis of adaptive and flexible clinical trials, allowing readers to select and design the appropriate trial designs from a conceptual perspective. From basic theory to real-life practical issues, it covers all aspects of adaptive and flexible clinical trials, including regulatory issues, interim analysis, adaptive dosing, and sequential designs.

Ghost-Managed Medicine

Ghost-Managed Medicine
  • Author : SERGIO. SISMONDO
  • Publisher :Unknown
  • Release Date :2018-07-23
  • Total pages :234
  • ISBN : 0995527776
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Summary : Ghost-Managed Medicine probes the pharmaceutical industry and its agents as they work to shape medicine and createmarkets for drugs. The book traces paths of information about drugs, from the extraction of data from experimental bodies to articles ghostwritten for researchers to manifold infl uences of doctors and consumers.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
  • Author : Divya Vohora,Gursharan Singh
  • Publisher :Unknown
  • Release Date :2017-11-14
  • Total pages :526
  • ISBN : 9780128020982
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Summary : Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

The Indestructible Brand

The Indestructible Brand
  • Author : Venke Sharma,Hushidar Kharas
  • Publisher :Unknown
  • Release Date :2017-06-27
  • Total pages :172
  • ISBN : 9789386446800
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Summary : Whether or not your brand is on social media, your consumers are. They are continuously sharing their good and bad experiences about your brand. Most brands are not prepared to deal with negative feedback which, if ignored, can spiral into a crisis. This book seeks to aid brand and business owners to structure organizations to be crisis- ready. Creating a crisis squad and a crisis playbook, envisioning various scenarios that can occur, and what the brand’s response should be are some of the areas the book delves into. It also recommends preventive measures that can save brands from social embarrassment, and social listening strategies that can alert organizations to a problem before it becomes a crisis. When everything else fails and a crisis is at hand, the focus shifts to executing the playbook, turning the conversation around leveraging evangelists and influencers. Once the crisis has ended, it’s time to audit the playbook and close the gaps, as well as evaluate financial or reputational damage done to the brand, and see how quickly one can recover.

Ten Types of Innovation

Ten Types of Innovation
  • Author : Larry Keeley,Helen Walters,Ryan Pikkel,Brian Quinn
  • Publisher :Unknown
  • Release Date :2013-07-15
  • Total pages :288
  • ISBN : 9781118571392
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Summary : Innovation principles to bring about meaningful and sustainablegrowth in your organization Using a list of more than 2,000 successful innovations,including Cirque du Soleil, early IBM mainframes, the Ford Model-T,and many more, the authors applied a proprietary algorithm anddetermined ten meaningful groupings—the Ten Types ofInnovation—that provided insight into innovation. The TenTypes of Innovation explores these insights to diagnosepatterns of innovation within industries, to identify innovationopportunities, and to evaluate how firms are performing againstcompetitors. The framework has proven to be one of the mostenduring and useful ways to start thinking abouttransformation. Details how you can use these innovation principles to bringabout meaningful—and sustainable—growth within yourorganization Author Larry Keeley is a world renowned speaker, innovationconsultant, and president and co-founder of Doblin, the innovationpractice of Monitor Group; BusinessWeek named Keeley one of sevenInnovation Gurus who are changing the field The Ten Types of Innovation concept has influenced thousands ofexecutives and companies around the world since its discovery in1998. The Ten Types of Innovation is the first bookexplaining how to implement it.

Implementation Research in Health

Implementation Research in Health
  • Author : David H. Peters,Nhan T. Tran,Taghreed Adam,World Health Organization
  • Publisher :Unknown
  • Release Date :2013
  • Total pages :67
  • ISBN : 9789241506212
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Summary : Interest in implementation research is growing, largely in recognition of the contribution it can make to maximizing the beneficial impact of health interventions. As a relatively new and, until recently, rather neglected field within the health sector, implementation research is something of an unknown quantity for many. There is therefore a need for greater clarity about what exactly implementation research is, and what it can offer. This Guide is designed to provide that clarity. Intended to support those conducting implementation research, those with responsibility for implementing programs, and those who have an interest in both, the Guide provides an introduction to basic implementation research concepts and language, briefly outlines what it involves, and describes the many opportunities that it presents. The main aim of the Guide is to boost implementation research capacity as well as demand for implementation research that is aligned with need, and that is of particular relevance to health systems in low- and middle-income countries (LMICs). Research on implementation requires the engagement of diverse stakeholders and multiple disciplines in order to address the complex implementation challenges they face. For this reason, the Guide is intended for a variety of actors who contribute to and/or are impacted by implementation research. This includes the decision-makers responsible for designing policies and managing programs whose decisions shape implementation and scale-up processes, as well as the practitioners and front-line workers who ultimately implement these decisions along with researchers from different disciplines who bring expertise in systematically collecting and analyzing information to inform implementation questions. The opening chapters (1-4) make the case for why implementation research is important to decision-making. They offer a workable definition of implementation research and illustrate the relevance of research to problems that are often considered to be simply administrative and provide examples of how such problems can be framed as implementation research questions. The early chapters also deal with the conduct of implementation research, emphasizing the importance of collaboration and discussing the role of implementers in the planning and designing of studies, the collection and analysis of data, as well as in the dissemination and use of results. The second half of the Guide (5-7) detail the various methods and study designs that can be used to carry out implementation research, and, using examples, illustrates the application of quantitative, qualitative, and mixed-method designs to answer complex questions related to implementation and scale-up. It offers guidance on conceptualizing an implementation research study from the identification of the problem, development of research questions, identification of implementation outcomes and variables, as well as the selection of the study design and methods while also addressing important questions of rigor.