Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
Author: John I. Gallin,Frederick P Ognibene,Laura Lee Johnson
Publsiher: Academic Press
Total Pages: 824
Release: 2017-11-17
ISBN: 0128499044
Category: Science
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Research Book Excerpt:

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
Author: John I. Gallin,Frederick P Ognibene
Publsiher: Elsevier
Total Pages: 448
Release: 2011-04-28
ISBN: 9780080489568
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Research Book Excerpt:

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

Principles and Practice of Clinical Trial Medicine
Author: Richard Chin,Bruce Y Lee
Publsiher: Elsevier
Total Pages: 560
Release: 2008-07-25
ISBN: 9780080557939
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Trial Medicine Book Excerpt:

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 Trial Medicine

Principles and Practice of Clinical Trial Medicine
Author: Richard Yoonsik Chin,Bruce Y. Lee
Publsiher: Academic Press
Total Pages: 547
Release: 2008
ISBN: 9780123736956
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Clinical Trial Medicine Book Excerpt:

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.

Global Clinical Trials Playbook

Global Clinical Trials Playbook
Author: Menghis Bairu,Richard Chin
Publsiher: Academic Press
Total Pages: 320
Release: 2012-06-12
ISBN: 0124158609
Category: Medical
Language: EN, FR, DE, ES & NL

Global Clinical Trials Playbook Book Excerpt:

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

Success in Academic Surgery Clinical Trials

Success in Academic Surgery  Clinical Trials
Author: Timothy M. Pawlik,Julie A. Sosa
Publsiher: Springer Science & Business Media
Total Pages: 183
Release: 2013-11-04
ISBN: 1447146794
Category: Medical
Language: EN, FR, DE, ES & NL

Success in Academic Surgery Clinical Trials Book Excerpt:

Surgical education is a rapidly expanding area of surgical research and career interest, and as the Association for Academic Surgery (AAS) Fall Courses (www.aasurg.org) and International courses offer more and more specialty tracking there is a greater need for an accompanying textbook to supplement the material presented in the courses.

Behavioral Clinical Trials for Chronic Diseases

Behavioral Clinical Trials for Chronic Diseases
Author: Lynda H. Powell
Publsiher: Springer Nature
Total Pages: 135
Release: 2022
ISBN: 3030393305
Category: Electronic Book
Language: EN, FR, DE, ES & NL

Behavioral Clinical Trials for Chronic Diseases Book Excerpt:

Principles and Practice of Pharmaceutical Medicine

Principles and Practice of Pharmaceutical Medicine
Author: Lionel D. Edwards,Andrew J. Fletcher,Anthony W. Fox,Peter D. Stonier
Publsiher: John Wiley & Sons
Total Pages: 780
Release: 2007-04-30
ISBN: 9780470093146
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Pharmaceutical Medicine Book Excerpt:

The long awaited second edition of Principles and Practice of Pharmaceutical Medicine provides an invaluable guide to all areas of drug development and medical aspects of marketing. The title has been extensively revised and expanded to include the latest regulatory and scientific developments. New chapters include: European Regulations Ethics of Pharmaceutical Medicine Licensing and Due Diligence Pharmacogenomics Encompassing the entire spectrum of pharmaceutical medicine, it is the most up-to-date international guide currently available. Review of the first edition: “This book was a joy to read and a joy to review. All pharmaceutical physicians should have a copy on their bookshelves, all pharmaceutical companies should have copies in their libraries.” —BRITISH ASSOCIATION OF PHARMACEUTICAL PHYSICIANS

Modern Pharmaceutical Industry

Modern Pharmaceutical Industry
Author: Thomas Jacobsen,Albert Wertheimer
Publsiher: Jones & Bartlett Learning
Total Pages: 317
Release: 2010-10-25
ISBN: 0763766364
Category: Business & Economics
Language: EN, FR, DE, ES & NL

Modern Pharmaceutical Industry Book Excerpt:

With its expansion into the global marketplace, the pharmaceutical industry of today is uniquely positioned to improve the global health standards of society by saving lives and improving the quality of lives around the world. Modern Pharmaceutical Industry: A Primer comprehensively explains the broad range of divisions in this complex industry. Experts actively involved in each division discuss their own contribution to a pharmaceutical company's work and success. Divisions include regulatory affairs, research and development, intellectual property, pricing, marketing, generics, OTC, and more

The NIH Catalyst

The NIH Catalyst
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2004
ISBN: 1928374650XXX
Category: Electronic government information
Language: EN, FR, DE, ES & NL

The NIH Catalyst Book Excerpt:

The Medical Legal Aspects of Acute Care Medicine

The Medical Legal Aspects of Acute Care Medicine
Author: James E. Szalados
Publsiher: Springer Nature
Total Pages: 700
Release: 2021-04-02
ISBN: 3030685705
Category: Medical
Language: EN, FR, DE, ES & NL

The Medical Legal Aspects of Acute Care Medicine Book Excerpt:

The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a comprehensive resource intended to provide a state-of-the-art overview of complex ethical, regulatory, and legal issues of importance to clinical healthcare professionals in the area of acute care medicine; including, for example, physicians, advanced practice providers, nurses, pharmacists, social workers, and care managers. In addition, this book also covers key legal and regulatory issues relevant to non-clinicians, such as hospital and practice administrators; department heads, educators, and risk managers. This text reviews traditional and emerging areas of ethical and legal controversies in healthcare such as resuscitation; mass-casualty event response and triage; patient autonomy and shared decision-making; medical research and teaching; ethical and legal issues in the care of the mental health patient; and, medical record documentation and confidentiality. Furthermore, this volume includes chapters dedicated to critically important topics, such as team leadership, the team model of clinical care, drug and device regulation, professional negligence, clinical education, the law of corporations, tele-medicine and e-health, medical errors and the culture of safety, regulatory compliance, the regulation of clinical laboratories, the law of insurance, and a practical overview of claims management and billing. Authored by experts in the field, The Medical-Legal Aspects of Acute Care Medicine: A Resource for Clinicians, Administrators, and Risk Managers is a valuable resource for all clinical and non-clinical healthcare professionals.

Principles and Practice of Research

Principles and Practice of Research
Author: Hans Troidl,Walter O. Spitzer,Bucknam McPeek,David S. Mulder,Martin F. McKneally,Andrew S. Wechsler,Charles M. Balch
Publsiher: Springer Science & Business Media
Total Pages: 566
Release: 2012-12-06
ISBN: 1468403710
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Research Book Excerpt:

What is the best way to plan surgical research? What problems are most often encountered in clinical research? How should a research report be presented at a scientific meeting? These questions and more are all answered in Principles and Practice of Research.The second edition has added new sections on animal research models, the molecular and cellular dimension of surgical research, and practical guidelines for obtaining government and third-party funding. Other improvements include a friendlier discussion of statistics and updated material about on-line computer literature searches. This book provides every clinical researcher with a roadmap around the pitfalls of poorly designed studies, through the jungle of incomprehensible statistics, and over the hurdles of research reporting to a successful study from start to finish. From the reviews of the first edition: "For me, it is a bible and a must for every Ph.D. or M.D. involved in clinical research, especially in the field of surgery. It should be on the table - not on the book shelf - of both the young as well as the experienced investigator as a readily accessible source of information to avoid the trial-and-error approach to problems in surgical research." #World Journal of Surgery#1 "...a carefully conceived, concise blend of factual theory and principles, practical guidelines, and philosophical perspective... ...I have found it hard to identify any omission (even a selected bibliography on laboratory animals, their care, handling, and anatomy is included) and impossible to single out any individual contribution: each is a treasure - well written, concise, and complete." #The Lancet#2 "The feature of the book is that, despite attention to detail, it maintains a clear and practical approach to the whole field, beginning with the reasons for carrying out research, the types of research, and above all the reporting of research... ...Almost all aspects of research are covered, from small retrospective studies to departmental, institutional, national and international projects... ...The chapter on writing for publication should be compulsory reading for all budding authors." #Journal of Bone and Joint Surgery#3

Rheumatoid Arthritis E Book

Rheumatoid Arthritis E Book
Author: Marc C. Hochberg,Alan J. Silman,Josef S. Smolen,Michael E. Weinblatt,Michael H. Weisman
Publsiher: Elsevier Health Sciences
Total Pages: 464
Release: 2008-11-07
ISBN: 0323071023
Category: Medical
Language: EN, FR, DE, ES & NL

Rheumatoid Arthritis E Book Book Excerpt:

First Prize, Orthopaedics and Rheumatology, BMA Awards 2009 This state-of-the-art reference provides current insights into the etiology, diagnosis and management of rheumatoid arthritis. Leading international authorities in RA examine all of the latest scientific and clinical developments in understanding and managing this challenging disease, including new concepts in pathogenesis, epidemiology, risk factors, imaging, clinical outcomes and treatment. It’s the guidance you need to offer optimal care to your patients with rheumatoid arthritis. Presents the work of leading international experts in rheumatoid arthritis for guidance you can trust. Provides the very latest understanding of the pathogenesis of rheumatoid arthritis, including molecular pathways/mechanisms, and genetic and environmental factors that instigate and drive the disease. Includes comprehensive coverage of clinical features of rheumatoid arthritis including articular, peri-articular and extra-articular manifestations, comorbidities, and outcome measures—disease activity, joint assessment, imaging, and more—for expert diagnosis and monitoring of disease progression. Examines evidence-based treatment options—including traditional and biologic DMARDs and combination therapies—as well as promising therapies on the horizon, placing up-to-date guidance on disease modifying or disease controlling agents at your fingertips.

G3P Good Privacy Protection Practice in Clinical Research

G3P   Good Privacy Protection Practice in Clinical Research
Author: Karl-Heinz Schriever,Markus Schröder
Publsiher: Walter de Gruyter GmbH & Co KG
Total Pages: 210
Release: 2014-10-02
ISBN: 311028328X
Category: Medical
Language: EN, FR, DE, ES & NL

G3P Good Privacy Protection Practice in Clinical Research Book Excerpt:

Establishing ethical and privacy protection aspects in scientific research, especially in medical research, has a long history. Medical data are usually more sensible than other personal data and require therefore an even higher degree of protection than other personal data. In recent research projects genetic evaluations become more and more important and trigger thereby new and continuing activities in the context of data protection. Genetic data as a subset of medical data are the most sensible category of personal data and require therefore the highest degree of data protection. The book provides a systematic and itemized approach to data protection in clinical research including the handling of genetic material, genetic samples as well as derived genetic data and the subsequent secure storage of them. The set up of different kinds of clinical trials having in addition a genetic part, the concept of a genetic informed consent as well as collection schemes of samples are described in detail. Technical requirements and aspects of data protection including pseudonymization and anonymization procedures taking into account ethics committees requirements as well as the underlying legal framework are also presented. Without any exception, all principles and methods presented are best practices, repeatedly applied in different clinical environments and by no means theoretical considerations.

Principles and Practice of Gynecologic Oncology

Principles and Practice of Gynecologic Oncology
Author: Richard R. Barakat,Maurie Markman,Marcus Randall
Publsiher: Lippincott Williams & Wilkins
Total Pages: 1072
Release: 2009
ISBN: 078177845X
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Gynecologic Oncology Book Excerpt:

Providing comprehensive coverage of the biology of gynecologic cancer, the therapeutic modalities available, and the diagnosis and treatment of site-specific malignancies, this edition has 30 percent new contributing authors and new material. A companion Web site offers a fully searchable text.

Biostatistics in Clinical Trials

Biostatistics in Clinical Trials
Author: Carol K. Redmond,Theodore Colton
Publsiher: John Wiley & Sons
Total Pages: 528
Release: 2001-04-25
ISBN: 9780471822110
Category: Medical
Language: EN, FR, DE, ES & NL

Biostatistics in Clinical Trials Book Excerpt:

The second volume in the Wiley reference series in Biostatistics. Featuring articles from the prestigious Encyclopedia of Biostatistics, many of which have been fully revised and updated to include recent developments, Biostatistics in Clinical Trials also includes up to 25% newly commissioned material reflecting the latest thinking in: Bayesian methods Benefit/risk assessment Cost-effectiveness Ethics Fraud With exceptional contributions from leading experts in academia, government and industry, Biostatistics in Clinical Trials has been designed to complement existing texts by providing extensive, up-to-date coverage and introducing the reader to the research literature. Offering comprehensive coverage of all aspects of clinical trials Biostatistics in Clinical Trials: Includes concise definitions and introductions to numerous concepts found in current literature Discusses the software and textbooks available Uses extensive cross-references helping to facilitate further research and enabling the reader to locate definitions and related concepts Biostatistics in Clinical Trials offers both academics and practitioners from various disciplines and settings, such as universities, the pharmaceutical industry and clinical research organisations, up-to-date information as well as references to assist professionals involved in the design and conduct of clinical trials.

Principles and Practice of Gynecologic Oncology

Principles and Practice of Gynecologic Oncology
Author: William J. Hoskins
Publsiher: Lippincott Williams & Wilkins
Total Pages: 1419
Release: 2005
ISBN: 9780781746892
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Gynecologic Oncology Book Excerpt:

This updated Fourth Edition provides comprehensive coverage of the biology of gynecologic cancer, the therapeutic modalities available, and the diagnosis and treatment of site-specific malignancies. Because of the importance of multimodality treatment, the site-specific chapters are co-authored by a surgical oncologist, a medical oncologist, a radiation oncologist, and a pathologist. A significant portion of this edition focuses on monoclonal antibodies, vaccines, and gene directed therapies and how they can greatly improve treatment outcomes. A new chapter on end-of-life care is also included. Three distinguished new editors—Richard R. Barakat, MD, Maurie Markman, MD, and Marcus E. Randall, MD—now join the editorial team.

Clinical Research in Oral Health

Clinical Research in Oral Health
Author: William V. Giannobile,Brian A. Burt,Robert J. Genco
Publsiher: Wiley-Blackwell
Total Pages: 392
Release: 2010-03-16
ISBN: 9780813815299
Category: Medical
Language: EN, FR, DE, ES & NL

Clinical Research in Oral Health Book Excerpt:

Clinical Research in Oral Health surveys the essentials of clinical research in oral health, anchoring these principles within the specific context of the oral health arena. Addressing research questions exclusively applicable to dentistry and oral health, the book thoroughly illustrates the principles and practice of oral health clinical research. Clinical Research in Oral Health also clarifies the framework of regulatory issues and presents emerging concepts in clinical translation, relating the research principles to clinical improvement.

Principles and Practice of Ophthalmology E Book

Principles and Practice of Ophthalmology E Book
Author: Daniel M. Albert,Joan W. Miller,Dimitri T. Azar,Barbara A. Blodi
Publsiher: Elsevier Health Sciences
Total Pages: 5502
Release: 2008-02-27
ISBN: 1437721117
Category: Medical
Language: EN, FR, DE, ES & NL

Principles and Practice of Ophthalmology E Book Book Excerpt:

Inside the 3rd edition of this esteemed masterwork, hundreds of the most distinguished authorities from around the world provide today's best answers to every question that arises in your practice. They deliver in-depth guidance on new diagnostic approaches, operative technique, and treatment option, as well as cogent explanations of every new scientific concept and its clinical importance. With its new streamlined, more user-friendly, full-color format, this 3rd edition makes reference much faster, easier, and more versatile. More than ever, it's the source you need to efficiently and confidently overcome any clinical challenge you may face. Comprehensive, authoritative, and richly illustrated coverage of every scientific and clinical principle in ophthalmology ensures that you will always be able to find the guidance you need to diagnose and manage your patients' ocular problems and meet today's standards of care. Updates include completely new sections on "Refractive Surgery" and "Ethics and Professionalism"... an updated and expanded "Geneitcs" section... an updated "Retina" section featuring OCT imaging and new drug therapies for macular degeneration... and many other important new developments that affect your patient care. A streamlined format and a new, more user-friendly full-color design - with many at-a-glance summary tables, algorithms, boxes, diagrams, and thousands of phenomenal color illustrations - allows you to locate the assistance you need more rapidly than ever.

Rheumatology E Book

Rheumatology E Book
Author: Marc C. Hochberg,Alan J. Silman,Josef S. Smolen,Michael E. Weinblatt,Michael H. Weisman
Publsiher: Elsevier Health Sciences
Total Pages: 2112
Release: 2014-06-16
ISBN: 0702063037
Category: Medical
Language: EN, FR, DE, ES & NL

Rheumatology E Book Book Excerpt:

Stay current in the ever-changing discipline of rheumatology with clear, reliable guidance from Hochberg’s Rheumatology, one of the most respected and trusted sources in the field. Designed to meet the needs of the practicing clinician, this medical reference book provides extensive, authoritative coverage of rheumatic diseases from basic scientific principles to practical points of clinical management in a lucid, logical, user-friendly manner. Track disease progression and treat patients more effectively with the information on genetic findings, imaging outcomes, cell and biologic therapies, rheumatoid arthritis, and SLE. Incorporate recent findings about pathogenesis of disease; imaging outcomes for specific diseases like RA, osteoarthritis, and spondyloarthropathies; cell and biologic therapies; and other timely topics. Remain up to date on the latest information in rheumatology through 13 brand-new chapters covering biomedical and translation science, disease and outcome assessment, new imaging modalities, early emerging disease, clinical therapeutics, patient management, and rehabilitation. Take advantage of expanded coverage of small molecule treatment, biologics, biomarkers, epigenetics, biosimilars, and cell-based therapies. Focus on the core knowledge needed for successful results with each chapter co-authored by an internationally-renowned specialist in the field. Easily find the information you need thanks to a consistent, user-friendly format with templated content and large-scale images.