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Principles And Practice Of Clinical Trial Medicine

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Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine Book
Author : Richard Yoonsik Chin,Bruce Y. Lee
Publisher : Academic Press
Release : 2008
ISBN : 9780123736956
Language : En, Es, Fr & De

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Book Description :

A concise overview of the essential aspects of clinical research and trial design. Presents the principles and practical details needed to design, conduct, and interpret the results on clinical trials, as well as how to take a drug from initial development to approval stage.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research Book
Author : John I. Gallin,Frederick P Ognibene
Publisher : Elsevier
Release : 2011-04-28
ISBN : 9780080489568
Language : En, Es, Fr & De

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Book Description :

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 Trials

Principles and Practice of Clinical Trials Book
Author : Steven Piantadosi,Curtis L. Meinert
Publisher : Springer
Release : 2022-09-21
ISBN : 9783319526355
Language : En, Es, Fr & De

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Book Description :

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.

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine Book
Author : Richard Chin,Bruce Y Lee
Publisher : Elsevier
Release : 2008-07-25
ISBN : 9780080557939
Language : En, Es, Fr & De

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Book Description :

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

Clinical Trials in Cancer

Clinical Trials in Cancer Book
Author : David J. Girling
Publisher : Oxford University Press, USA
Release : 2003
ISBN : 9780192629593
Language : En, Es, Fr & De

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Book Description :

Clinical Trials in Cancer provides concise, accessible and practical information on the practicalities of planning, designing, conducting, analysing, reporting, and interpreting phase III clinical trials predominantly, but also single-arm and randomized phase II trials. The book shows clearly how recent developments and current thinking can be implemented. Information on the need to decide and measure realistic target differences in trials, the conduct and interpretation of interim analyses, patient advocacy, good clinical practice, the study of quality of life, the role of meta-analyses, and informed consent and other ethical issues are also covered. DEGREESNL This book will prove invaluable for medical, statistical, and biological cancer researchers, health care professionals, and researchers in the pharmaceutical industry. Trial sponsors, principal investigators, members of data monitoring and trial supervisory committees, specialists invited to provide independent assessments, and many others involved in all aspects of research related to clinical trials should also find this book helpful.

Clinical Trials

Clinical Trials Book
Author : Stuart J. Pocock
Publisher : John Wiley & Sons
Release : 2013-07-17
ISBN : 1118794109
Language : En, Es, Fr & De

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Book Description :

This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

Sharing Clinical Trial Data

Sharing Clinical Trial Data Book
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Publisher : National Academies Press
Release : 2015-04-20
ISBN : 0309316324
Language : En, Es, Fr & De

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Book Description :

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Principles of Good Clinical Practice

Principles of Good Clinical Practice Book
Author : Michael J. McGraw,Thomas F. Haws, Jr.
Publisher : Pharmaceutical Press
Release : 2010
ISBN : 0853697906
Language : En, Es, Fr & De

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Book Description :

Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research Book
Author : John I. Gallin,Frederick P Ognibene
Publisher : Academic Press
Release : 2012-05-31
ISBN : 0123821673
Language : En, Es, Fr & De

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Book Description :

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.

Critical Thinking in Clinical Research

Critical Thinking in Clinical Research Book
Author : Felipe Fregni,Ben M. W. Illigens
Publisher : Oxford University Press
Release : 2018
ISBN : 0199324492
Language : En, Es, Fr & De

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Book Description :

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.

A Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials Book
Author : JoAnn Pfeiffer,Cris Wells
Publisher : CRC Press
Release : 2017-05-18
ISBN : 1315299771
Language : En, Es, Fr & De

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Book Description :

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 Phytotherapy E Book

Principles and Practice of Phytotherapy   E Book Book
Author : Kerry Bone,Simon Mills
Publisher : Elsevier Health Sciences
Release : 2013-01-08
ISBN : 0702052973
Language : En, Es, Fr & De

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Book Description :

The authoritative and comprehensive modern textbook on western herbal medicine - now in its second edition This long-awaited second edition of Principles and Practice of Phytotherapy covers all major aspects of herbal medicine from fundamental concepts, traditional use and scientific research through to safety, effective dosage and clinical applications. Written by herbal practitioners with active experience in clinical practice, education, manufacturing and research, the textbook is both practical and evidence based. The focus, always, is on the importance of tailoring the treatment to the individual case. New insights are given into the herbal management of approxiately 100 modern ailments, including some of the most challenging medical conditions, such as asthma, inflammatory bowel disease and other complex autoimmune and inflammatory conditions, and there is vibrant discussion around the contribution of phytotherapy in general to modern health issues, including health ageing. Fully referenced throughout, with more than 10, 000 citations, the book is a core resource for students and practitioners of phytotherapy and naturopathy and will be of value to all healthcare professionals - pharmacists, doctors, nurses - with an interest in herbal therapeutics. 50 evidence-based monographs, including 7 new herbs Rational guidance to phytotherapeutic strategies in the consulting room New appendices provide useful information on topics such as herbal actions, dosage in children and reading and interpreting herbal clinical trials Comprehensive revision of vital safety data, including an extensive herb-drug interaction chart. 50 evidence-based monographs, including 7 new herbs Rational guidance to phytotherapeutic strategies in the consulting room New appendices provide useful information on topics such as herbal actions, dosage in children and reading and interpreting herbal clinical trials Comprehensive revision of vital safety data, including an extensive herb-drug interaction chart.

Principles of Clinical Research

Principles of Clinical Research Book
Author : Institute of Clinical Research
Publisher : Routledge
Release : 2001
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

In an arena which has seen rapid change over the past decade, this work provides a comprehensive and up-to-date guide to the planning, organization and management of clinical trials.

Principles of Translational Science in Medicine

Principles of Translational Science in Medicine Book
Author : Martin Wehling
Publisher : Academic Press
Release : 2021-07-15
ISBN : 032399962X
Language : En, Es, Fr & De

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Book Description :

Principles of Translational Science in Medicine: From Bench to Bedside, Third Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing number of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. New chapters include: Translation in Oncology, Biologicals, and Orphan Drugs. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine and is written by worldwide experts in their respective fields. Includes state-of-the-art principles, tools such as biomarkers and early clinical trials, algorithms of translational science in medicine Provides in-depth description of special translational aspects in the currently most successful areas of clinical translation, namely oncology and immunology Covers status of institutionalization of translational medicine, networking structures and outcomes at the level of marketing authorization

Principles of Research Methodology

Principles of Research Methodology Book
Author : Phyllis G. Supino,Jeffrey S. Borer
Publisher : Springer Science & Business Media
Release : 2012-06-22
ISBN : 1461433606
Language : En, Es, Fr & De

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Book Description :

Principles of Research Methodology: A Guide for Clinical Investigators is the definitive, comprehensive guide to understanding and performing clinical research. Designed for medical students, physicians, basic scientists involved in translational research, and other health professionals, this indispensable reference also addresses the unique challenges and demands of clinical research and offers clear guidance in becoming a more successful member of a medical research team and critical reader of the medical research literature. The book covers the entire research process, beginning with the conception of the research problem to publication of findings. Principles of Research Methodology: A Guide for Clinical Investigators comprehensively and concisely presents concepts in a manner that is relevant and engaging to read. The text combines theory and practical application to familiarize the reader with the logic of research design and hypothesis construction, the importance of research planning, the ethical basis of human subjects research, the basics of writing a clinical research protocol and scientific paper, the logic and techniques of data generation and management, and the fundamentals and implications of various sampling techniques and alternative statistical methodologies. Organized in thirteen easy to read chapters, the text emphasizes the importance of clearly-defined research questions and well-constructed hypothesis (reinforced throughout the various chapters) for informing methods and in guiding data interpretation. Written by prominent medical scientists and methodologists who have extensive personal experience in biomedical investigation and in teaching key aspects of research methodology to medical students, physicians and other health professionals, the authors expertly integrate theory with examples and employ language that is clear and useful for a general medical audience. A major contribution to the methodology literature, Principles of Research Methodology: A Guide for Clinical Investigators is an authoritative resource for all individuals who perform research, plan to perform it, or wish to understand it better.

Principles and Practice of Trial Consultation

Principles and Practice of Trial Consultation Book
Author : Stanley L. Brodsky
Publisher : Guilford Press
Release : 2009-05-04
ISBN : 1606233904
Language : En, Es, Fr & De

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Book Description :

A pragmatic guide to a growing area of professional practice, this book describes the multiple roles of the trial consultant and provides tools for carrying them out competently and ethically. Leading authority Stanley Brodsky uses examples from actual trials and depositions to illustrate how knowledge and skills from psychology and related fields are applied in the legal context. He shows how to use scientific methods and findings to assist with jury selection, help attorneys focus their arguments, prepare witnesses for the rigors of cross-examination, and conduct change of venue evaluations. The examples are drawn from a wide range of civil and criminal cases. In addition to behavioral scientists, legal professionals also will find important insights and strategies in this book.

Statistical Design Monitoring and Analysis of Clinical Trials

Statistical Design  Monitoring  and Analysis of Clinical Trials Book
Author : Weichung Joe Shih,Joseph Aisner
Publisher : CRC Press
Release : 2021-10-26
ISBN : 1000462811
Language : En, Es, Fr & De

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Book Description :

Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters. Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations. This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.

Neuroepidemiology

Neuroepidemiology Book
Author : Lorene M. Nelson,Caroline M. Tanner,Stephen Van Den Eeden,Valerie M. McGuire
Publisher : Oxford University Press
Release : 2004
ISBN : 019513379X
Language : En, Es, Fr & De

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Book Description :

This fine text provides a comprehensive overview of methods for epidemiologic and clinical research on neurological disorders. The book focuses on classic principles of study design in epidemiologic research, strategies for avoiding study biases, methods for conducting clinical trials and prognostic studies, and principles of evidence-based medicine in neurology. The text gives neurologists, epidemiologists, and their students the foundation for conducting rigorous epidemiologic and clinical research on neurologic disorders.

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials Book
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
Release : 2011-01-21
ISBN : 0309158141
Language : En, Es, Fr & De

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Book Description :

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.

Pathy s Principles and Practice of Geriatric Medicine

Pathy s Principles and Practice of Geriatric Medicine Book
Author : Alan J. Sinclair,John E. Morley,Bruno Vellas
Publisher : John Wiley & Sons
Release : 2012-03-13
ISBN : 1119954142
Language : En, Es, Fr & De

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Book Description :

This new edition of the comprehensive and renowned textbook Principles and Practice of Geriatric Medicine offers a fully revised and updated review of geriatric medicine. It covers the full spectrum of the subject, features 41 new chapters, and provides up-to-date, evidence-based, and practical information about the varied medical problems of ageing citizens. The three editors, from UK, USA and France, have ensured that updated chapters provide a global perspective of geriatric medicine, as well as reflect the changes in treatment options and medical conditions which have emerged since publication of the 4th edition in 2006. The book includes expanded sections on acute stroke, dementia, cardiovascular disease, and respiratory diseases, and features a new section on end-of-life care. In the tradition of previous editions, this all-encompassing text continues to be a must-have text for all clinicians who deal with older people, particularly geriatric medical specialists, gerontologists, researchers, and general practitioners. This title is also available as a mobile App from MedHand Mobile Libraries. Buy it now from Google Play or the MedHand Store. Praise for the 4th edition: "...an excellent reference for learners at all clinical and preclinical levels and a useful contribution to the geriatric medical literature." —Journal of the American Medical Association, November 2006 5th edition selected for 2012 Edition of Doody's Core TitlesTM