An Introduction To Clinical Research

Author : Piers Page,James Carr,William Eardley,David Chadwick,Keith Porter
Publisher : OUP Oxford
Page : 224 pages
File Size : 48,8 Mb
Release : 2011-11-10
Category : Medical
ISBN : 9780191629594

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An Introduction to Clinical Research by Piers Page,James Carr,William Eardley,David Chadwick,Keith Porter Pdf

This practical book is written specifically for junior doctors by a team of highly experienced authors, as an introductory guide to clinical research. It covers all areas that a junior doctor needs to consider, including funding, study design, ethics, data analysis, disseminating findings, and furthering one's research career. It presents a balance view of clinical research and is written by authors actively involved in clinical research both at the 'coal-face' and at a more supervisory level. Research can be a difficult process and it is essential to make sure that the project is set up in the correct way in order to get verifiable results. This easy-to-read guide is available to help junior doctors develop a good study design and present evidence of a sound academic practice, which will make obtaining funding more likely and be time-efficient. Getting started early in research and developing a solid, gradual understanding of clinical research through using this approachable book will be of huge benefit to junior doctors and their discipline.

Author : Bryan Kestenbaum
Publisher : Springer Science & Business Media
Page : 242 pages
File Size : 44,8 Mb
Release : 2009-08-28
Category : Medical
ISBN : 9780387884332

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Epidemiology and Biostatistics by Bryan Kestenbaum Pdf

Concise, fast-paced, intensive introduction to clinical research design for students and clinical research professionals Readers will gain sufficient knowledge to pass the United States Medical Licensing Examination part I section in Epidemiology

Author : Stephen P. Glasser
Publisher : Springer
Page : 461 pages
File Size : 43,6 Mb
Release : 2014-06-02
Category : Medical
ISBN : 9783319054704

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Essentials of Clinical Research by Stephen P. Glasser Pdf

In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research. All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations. Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.

Author : Hesham Abdeldayem
Publisher : BoD – Books on Demand
Page : 91 pages
File Size : 52,9 Mb
Release : 2018-06-06
Category : Medical
ISBN : 9781789232387

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The Management of Clinical Trials by Hesham Abdeldayem Pdf

This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy.

Author : Chris Sauber,Dan Sfera
Publisher : Independently Published
Page : 218 pages
File Size : 44,7 Mb
Release : 2019-04-21
Category : Electronic
ISBN : 1090349521

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The Comprehensive Guide To Clinical Research by Chris Sauber,Dan Sfera Pdf

Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!In this book you will learn about:Regulations and the history as well as evolution of GCP.Clinical Research Site OperationsMonitoring Dynamics and Typical Monitoring VistsCRO ActivitiesSponsor Level DynamicsIndustry VendorsCommon Career Opportunities and Employment Roadmaps

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 52,6 Mb
Release : 2017-05-18
Category : Mathematics
ISBN : 9781315299778

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A Practical Guide to Managing Clinical Trials by JoAnn Pfeiffer,Cris Wells Pdf

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application. Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.

Author : Anonim
Publisher : Unknown
Page : 0 pages
File Size : 41,5 Mb
Release : 1972
Category : Research
ISBN : OCLC:784959525

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An Introduction to Clinical Research by Anonim Pdf

Author : J. Rick Turner
Publisher : Springer Science & Business Media
Page : 269 pages
File Size : 40,8 Mb
Release : 2010-07-16
Category : Medical
ISBN : 9781441964182

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New Drug Development by J. Rick Turner Pdf

New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 151 pages
File Size : 53,8 Mb
Release : 2010-10-22
Category : Medical
ISBN : 9780309163354

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Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Author : Bryan Kestenbaum
Publisher : Springer
Page : 277 pages
File Size : 55,7 Mb
Release : 2018-10-12
Category : Medical
ISBN : 9783319966441

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Epidemiology and Biostatistics by Bryan Kestenbaum Pdf

This is a concise introduction to epidemiology and biostatistics written specifically for medical students and first-time learners of clinical research methods. It presents the core concepts of epidemiology and of biostatistics and illustrates them with extensive examples from the clinical literature. It is the only book on the market written to speak directly to medical students and first-time biomedical researchers by using language and examples that are easy to understand. This newly updated second edition is extensively rewritten to provide the clearest explanations and examples. There is also a sister-text, a 150-problem workbook of practice problems that can be purchased alongside this textbook. The author continues to provide a text that is attractively fast-paced and concise for use in condensed courses, such as those taught in medical school. The book is an excellent review for the epidemiology section of the United States Medical Licensing Examination Part I which all medical students must take at the end of the second year.

Author : Lawrence M. Friedman,Curt Furberg,David L. DeMets
Publisher : Springer Science & Business Media
Page : 384 pages
File Size : 46,7 Mb
Release : 1998
Category : Clinical trials
ISBN : 0387985867

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Fundamentals of Clinical Trials by Lawrence M. Friedman,Curt Furberg,David L. DeMets Pdf

This classic reference, now updated with the newest applications and results, addresses the fundamentals of such trials based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

Author : John I. Gallin,Frederick P Ognibene
Publisher : Elsevier
Page : 447 pages
File Size : 49,9 Mb
Release : 2011-04-28
Category : Science
ISBN : 9780080489568

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Principles and Practice of Clinical Research by John I. Gallin,Frederick P Ognibene Pdf

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 127 pages
File Size : 49,9 Mb
Release : 2019-11-16
Category : Medical
ISBN : 9780309494885

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Virtual Clinical Trials by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Author : Prakash Nadkarni
Publisher : Academic Press
Page : 240 pages
File Size : 52,7 Mb
Release : 2016-04-29
Category : Medical
ISBN : 9780128031452

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Clinical Research Computing by Prakash Nadkarni Pdf

Clinical Research Computing: A Practitioner’s Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings Offers didactic content organization and an increasing complexity through the chapters

Author : John N.S. Matthews
Publisher : CRC Press
Page : 304 pages
File Size : 47,8 Mb
Release : 2006-06-26
Category : Mathematics
ISBN : 9781420011302

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Introduction to Randomized Controlled Clinical Trials by John N.S. Matthews Pdf

Evidence from randomized controlled clinical trials is widely accepted as the only sound basis for assessing the efficacy of new medical treatments. Statistical methods play a key role in all stages of these trials, including their justification, design, and analysis. This second edition of Introduction to Randomized Controlled Clinical Trials prov