Clinical Research And Practice

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Principles and Practice of Clinical Research

John I. Gallin,Frederick P Ognibene
Principles and Practice of Clinical Research Book PDF

Author : John I. Gallin,Frederick P Ognibene
Publisher : Elsevier
Page : 448 pages
File Size : 52,9 Mb
Release : 2011-04-28
Category : Medical
ISBN : 0080489567

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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

Principles and Practice of Clinical Trial Medicine

Richard Chin,Bruce Y Lee
Principles and Practice of Clinical Trial Medicine Book PDF

Author : Richard Chin,Bruce Y Lee
Publisher : Elsevier
Page : 560 pages
File Size : 43,5 Mb
Release : 2008-07-25
Category : Medical
ISBN : 0080557937

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Principles and Practice of Clinical Trial Medicine by Richard Chin,Bruce Y Lee Pdf

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

Principles and Practice of Clinical Trials

Steven Piantadosi,Curtis L. Meinert
Principles and Practice of Clinical Trials Book PDF

Author : Steven Piantadosi,Curtis L. Meinert
Publisher : Springer Nature
Page : 2573 pages
File Size : 41,6 Mb
Release : 2022-07-19
Category : Medical
ISBN : 9783319526362

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Principles and Practice of Clinical Trials by Steven Piantadosi,Curtis L. Meinert Pdf

This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.

Clinical Practice Guidelines We Can Trust

Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Clinical Practice Guidelines We Can Trust Book PDF

Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Publisher : National Academies Press
Page : 217 pages
File Size : 54,5 Mb
Release : 2011-06-16
Category : Medical
ISBN : 9780309216463

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Clinical Practice Guidelines We Can Trust by Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines Pdf

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Transforming Clinical Research in the United States

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

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 : 45,6 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.

Principles and Practice of Clinical Research

John I. Gallin,Frederick P Ognibene
Principles and Practice of Clinical Research Book PDF

Author : John I. Gallin,Frederick P Ognibene
Publisher : Academic Press
Page : 798 pages
File Size : 49,7 Mb
Release : 2012-05-31
Category : Medical
ISBN : 9780123821676

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

This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.

Foundations of Clinical Research

Leslie Gross Portney,Mary P. Watkins
Foundations of Clinical Research Book PDF

Author : Leslie Gross Portney,Mary P. Watkins
Publisher : Unknown
Page : 0 pages
File Size : 43,6 Mb
Release : 2015
Category : Biomedical Research
ISBN : 0803646577

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Foundations of Clinical Research by Leslie Gross Portney,Mary P. Watkins Pdf

Draw upon the foundations necessary for finding and interpreting research evidence across all healthcare professions. Revised to reflect the most current changes in the field of clinical research in rehabilitation and medicine, you'll find a growing emphasis on evidence-based practice (EBP) as well as new vocabulary that is being integrated into research and practice across disciplines.

Conflict of Interest in Medical Research, Education, and Practice

Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
Conflict of Interest in Medical Research Education and Practice Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
Publisher : National Academies Press
Page : 436 pages
File Size : 48,5 Mb
Release : 2009-09-16
Category : Medical
ISBN : 9780309145442

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Conflict of Interest in Medical Research, Education, and Practice by Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice Pdf

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Essentials of Clinical Research

Stephen P. Glasser
Essentials of Clinical Research Book PDF

Author : Stephen P. Glasser
Publisher : Springer
Page : 461 pages
File Size : 41,6 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.

Critical Thinking in Clinical Research

Felipe Fregni,Ben M. W. Illigens
Critical Thinking in Clinical Research Book PDF

Author : Felipe Fregni,Ben M. W. Illigens
Publisher : Oxford University Press
Page : 537 pages
File Size : 40,5 Mb
Release : 2018
Category : Medical
ISBN : 9780199324491

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Critical Thinking in Clinical Research by Felipe Fregni,Ben M. W. Illigens Pdf

Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all medical specialties.

Quick Guide to Good Clinical Practice

Cemal Cingi,Nuray Bayar Muluk
Quick Guide to Good Clinical Practice Book PDF

Author : Cemal Cingi,Nuray Bayar Muluk
Publisher : Springer
Page : 237 pages
File Size : 47,9 Mb
Release : 2016-11-15
Category : Medical
ISBN : 9783319443447

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Quick Guide to Good Clinical Practice by Cemal Cingi,Nuray Bayar Muluk Pdf

This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.

Clinical Research

Manfred Stommel,Celia Wills
Clinical Research Book PDF

Author : Manfred Stommel,Celia Wills
Publisher : Lippincott Williams & Wilkins
Page : 484 pages
File Size : 46,5 Mb
Release : 2004
Category : Medical
ISBN : 0781735181

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Clinical Research by Manfred Stommel,Celia Wills Pdf

This unique textbook integrates statistical concepts into evidence-based clinical practice and patient management. Research concepts and techniques are drawn from epidemiology, bio-statistics, and psychometrics, as well as educational and social science research. Clinical examples throughout the text illustrate practical and scientifically sound applications of the concepts. Data tables and research vignettes highlight statistical distributions involving probability. Methods to locate and utilize web-based information relevant to clinical research are discussed, and web URLs are provided. Further learning is encouraged by the inclusion of suggested activities, recommended readings, references, and a comprehensive glossary of research terms. Additional resources are available at a Connection Website, connection.LWW.com/go/stommel.

The Prevention and Treatment of Missing Data in Clinical Trials

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
The Prevention and Treatment of Missing Data in Clinical Trials Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 43,7 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

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The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

A Practical Guide to Managing Clinical Trials

JoAnn Pfeiffer,Cris Wells
A Practical Guide to Managing Clinical Trials Book PDF

Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Page : 292 pages
File Size : 51,9 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.

Principles and Practice of Clinical Research

John I. Gallin
Principles and Practice of Clinical Research Book PDF

Author : John I. Gallin
Publisher : Unknown
Page : 490 pages
File Size : 45,8 Mb
Release : 2002-01-01
Category : Medical
ISBN : 0122740653

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Principles and Practice of Clinical Research by John I. Gallin Pdf

A comprehensive text that addresses the theoretical and practical issues involved in conducting clinical research. Clinical research encompasses all studies involving human subjects-laboratory analysis of cell lines and tissues from patients, epidemiological studies and clinical trials of new drugs and treatments-directed at elucidating the causes of disease, as well as strategies for preventing and curing it. The book is based on the course materials for the Core Course on Clinical Research which has been given at the NIH for the past two years to their clinical fellows.