Essentials Of Clinical Research

Author : Stephen P. Glasser
Publisher : Springer
Page : 461 pages
File Size : 53,5 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 : Lawrence M. Friedman,Curt Furberg,David L. DeMets
Publisher : Springer Science & Business Media
Page : 384 pages
File Size : 49,6 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 : Ravindra B Dr Ghooi,Sachin C Itkar
Publisher : Unknown
Page : 244 pages
File Size : 40,7 Mb
Release : 2016-06-16
Category : Fiction
ISBN : 9380725094

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ESSENTIALS OF CLINICAL RESEARCH by Ravindra B Dr Ghooi,Sachin C Itkar Pdf

Introduction, Glossary& Drug Development Process, Clinical Trials on Drugs, Regulatory Strategy, Regulatory Control Over Drugs, Ethical Aspects of Clinical Research, sponsibility of Stakeholders, Clinical Trial Documents, Endpoints in Clinical Research, Site and Investigator Selection, Subject Recruitment and Selection, Meetings in Clinical Research, Data and Safety Monitoring, IND and NDA, Clinical Data Management, Safety Reporting and Pharmacoviligance, Quality Assurance in Clinical Research, Standard Operating Procedures, Clinical Research Outsourcing, Statistics in Clinical Research, Insurance and Liability, Non-compliance, Misconduct and Fraud, Intellectual Property Rights, Websites for Informa

Author : P. Michael Dubinsky,Karen A. Henry
Publisher : John Wiley & Sons
Page : 554 pages
File Size : 48,7 Mb
Release : 2022-01-26
Category : Medical
ISBN : 9781118949597

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The Fundamentals of Clinical Research by P. Michael Dubinsky,Karen A. Henry Pdf

This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources

Author : Ajit N Babu
Publisher : Wolters kluwer india Pvt Ltd
Page : 205 pages
File Size : 42,8 Mb
Release : 2014-01-01
Category : Medical
ISBN : 9789351293200

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Clinical Research Methodology and Evidence - Based Medicine by Ajit N Babu Pdf

Research methodology is a discipline concerned with the scientific conception, design, implementation and analysis of research. Evidence-based medicine (EBM) is an approach for evaluating and applying medical knowledge, particularly that derived from original research, in the care of individual patients. This book strives to give the reader a sound introduction to these related subjects which form a continuum. In this revised and expanded second edition, existing areas have been treated in greater depth, more examples provided and a number of fresh topics added. New chapters now address the finer points of survey design, provide tips on effective scientific writing for publication and outline the process of drug discovery from product conception to marketing. With these modifications, the book provides a more holistic picture of EBM and clinical research, appealing to a broader audience of medical students, practicing physicians, nursing staff, new investigators and researchers in CRO as well as the pharmaceutical industry.

Author : Rania Esteitie
Publisher : McGraw Hill Professional
Page : 119 pages
File Size : 47,8 Mb
Release : 2014-02-05
Category : Medical
ISBN : 9780071781657

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Medical Research Essentials by Rania Esteitie Pdf

LEARN THE EFFICIENT, EASY WAY TO CONDUCT MEDICAL RESEARCH PERFECT FOR ANYONE CONSIDERING A MEDICAL RESEARCH PROJECT! This concise handbook tells you everything you need to know about medical research. You will learn how to read, understand, and ultimately perform it. Medical Research Essentials walks you step by step through the entire research process, from how to read and critique an article, to presenting your own data. Filled with flowcharts, algorithms, diagrams, and tables, Medical Research Essentials is like having an experienced mentor at your side! THIS ULTIMATE HANDBOOK FOR INTERPRETING AND CONDUCTING MEDICAL RESEARCH OFFERS CONCISE COVERAGE OF: How to critically read and interpret medical literature The best methods of organizing and analyzing data Potential research projects that can be performed in a limited time frame How to design your own study and acquire funding Understanding and using medical statistics

Author : Sanjay Gupta
Publisher : Dna Press
Page : 1 pages
File Size : 44,5 Mb
Release : 2010
Category : Health & Fitness
ISBN : 9788190827713

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All You Need to Know about Clinical Research by Sanjay Gupta Pdf

This book is intended to provide a comprehensive understanding of the essential clinical trial elements in a concise fashion. It is intended to serve as a quick reference guide to all the personnel involved in the conduct of clinical trials as well as to those who plan to enter this field. Spanning over 167 pages the book provides a thorough compilation on, 1. Fundamentals of Clinical Research 2. Glossary of Clinical Trials Terminology (1052 frequently used terminologies of clinical research) 3. Abbreviations (224 frequently used terminologies of clinical research) 4. Clinical Trial Stakeholders 5. Clinical Study Process 6. Location of Essential Documents Before, During and After Completion of a Clinical Trial 7. Critical Milestones of a Clinical Trial Project 8. Overview of Regulatory Environment in USA, Australia, Europe, UK and India Being the first and only book on this important topic it has fulfilled the unmet need and is of great benefit to all the personnel involved in clinical research.

Author : Kenneth Schulz,David A. Grimes
Publisher : Elsevier Health Sciences
Page : 272 pages
File Size : 54,6 Mb
Release : 2018-07-19
Category : Medical
ISBN : 9780702073939

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Essential Concepts in Clinical Research by Kenneth Schulz,David A. Grimes Pdf

This practical guide speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials. Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods. Written by leaders in the field of clinical research who have published extensively with authorship of hundreds of articles in medical journals. The authorship includes one of the three authors of the CONSORT guidelines for the reporting of randomized controlled trials. The book presents the essential concepts to a wide array of topics including randomized control trials, descriptive studies, cohort studies, case-control studies, bias, and screening tests. The book utilises a readable and humorous prose style, lightening what can be a difficult area for clinical readers. Derived from decades of teaching clinical research in seminar settings the book will empower clinicians to make sense of, and critically appraise, current medical research and will enable researchers to enrich the quality of their work. The updated new edition includes six new chapters: Surrogate endpoints Limitations of observational epidemiology Participant recruitment Practicalities of double-blinding Randomized trials in the context of a prospective meta-analysis Reporting studies in medical journals: CONSORT

Author : Daniel Clauw
Publisher : Unknown
Page : 416 pages
File Size : 54,7 Mb
Release : 2009-04-01
Category : Medical
ISBN : 0071440763

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Essentials of Clinical Research by Daniel Clauw Pdf

Author : Kenneth F. Schulz,David A. Grimes
Publisher : Elsevier Health Sciences TW
Page : 248 pages
File Size : 43,8 Mb
Release : 2006
Category : Medical
ISBN : 9868379261

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The Lancet Handbook of Essential Concepts in Clinical Research by Kenneth F. Schulz,David A. Grimes Pdf

"The Lancet Handbook of Essential Concepts in Clinical Research speaks to two audiences: those who read and those who conduct research. Clinicians are medical detectives by training. For each patient, they assemble clinical clues to establish causes (e.g. diagnoses) of signs and symptoms. The task involves both clinical acumen and knowledge of medical research. This book helps guide clinicians through this detective work, by enabling them to make sense of research and to review medical literature critically. It will also be invaluable to researchers who conduct clinical research, particularly randomized controlled trials. Building on previously published, peer-reviewed articles from The Lancet, this handbook is essential for busy clinicians and active researchers interested in research methods."--BOOK JACKET.

Author : Phyllis G. Supino,Jeffrey S. Borer
Publisher : Springer Science & Business Media
Page : 286 pages
File Size : 54,7 Mb
Release : 2012-06-22
Category : Medical
ISBN : 9781461433606

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Principles of Research Methodology by Phyllis G. Supino,Jeffrey S. Borer Pdf

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.

Author : William F. Wright, DO, MPH
Publisher : Springer Publishing Company
Page : 450 pages
File Size : 52,5 Mb
Release : 2018-04-28
Category : Medical
ISBN : 9780826127822

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Essentials of Clinical Infectious Diseases, Second Edition by William F. Wright, DO, MPH Pdf

Praise for the previous edition: “Approaches near perfection...This is an excellent introduction to infectious diseases by a group of authors who take a straightforward and bullet-point approach to thinking and talking about clinical issues...”—Doody’s Reviews Updated second edition of the concise but comprehensive handbook covering clinical infectious disease for students, residents, primary care medical providers, nurses, and PAs. Written in outline format with short, focused chapters, the book presents a systematic method for understanding basic mechanisms, establishing a diagnosis, and implementing appropriate treatment for commonly encountered problems. Essentials of Clinical Infectious Diseases, Second Edition begins with a general framework covering basics of clinical reasoning, antimicrobial agents and microbiology, and antimicrobial stewardship. Individual chapters devoted to the broad range of infectious diseases and topics are organized by body system and feature targeted presentation of pathogenesis and risk factors, microbial causes, clinical manifestations, patient work-up, diagnostic criteria, and medical, antimicrobial, and surgical management. The book also addresses important related topics including fever and neutropenia, approach to evaluating ectoparasite-related infections, infectious diseases approach to sepsis, travel medicine, and basics of infection control and hospital epidemiology. Designed for busy practitioners at any level looking to sharpen the clinical problem-solving skills required to provide the highest quality care to patients with infectious diseases. Key Features: Includes a new bonus chapter that addresses severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), also known as coronavirus disease 2019 (COVID-19) Presents core clinical infectious disease topics in concise easy-to-read format Revised and updated to reflect recent developments in the field consistent with evidence-based literature and current clinical practice guidelines 6 new chapters on lyme disease, anorectal infections, travel medicine, dental infections, antimicrobial stewardship, and clinical reasoning and statistics Focus on the approach to evaluation and management of the patient Incorporates essential antimicrobial therapy information with adult, pediatric, and OB-GYN dosing considerations

Author : Felipe Fregni,Ben M. W. Illigens
Publisher : Oxford University Press
Page : 537 pages
File Size : 53,8 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.

Author : Olli Sakari Miettinen,Johann Steurer,A. Hofman
Publisher : Unknown
Page : 128 pages
File Size : 46,5 Mb
Release : 2019
Category : Clinical medicine
ISBN : 3030061779

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Clinical Research Transformed by Olli Sakari Miettinen,Johann Steurer,A. Hofman Pdf

This book delineates the fundamental transformations that, according to its precepts, are now needed in the objects and methods of 'patient-oriented' clinical research, in order to make it genuinely patient-relevant. These transformations are presented as providing for transition from today's 'evidence-based' practices (advocated by 'clinical epidemiologists') to knowledge-based succedanea of these. While those existing practices vary according to doctors' personal opinions about the burden of the available evidence, their knowledge-based succedanea will be essentially invariant across individual doctors, as they'll be guided by 'expert systems' (imbedded in cyberspace). At issue in this is transformation in what the authors present as the very essence of clinical medicine, namely clinical doctors' esoteric ad-hoc knowing: "gnosis." This is clinical doctors' knowing - probabilistic - about relevant-but-hidden truths about their patients' health, and constitutes the basis for their teaching ("doctoring") the patients about these esoteric insights. The probabilities are 'personalized' in the meaning of their specificity to the cases' gnostic profiles. Genuinely patient-relevant clinical knowledge this book presents as the requisite basis for three species of clinical doctors' gnosis: diagnosis - knowing about whether a particular type of illness is present (though hidden) in the patient; etiognosis - knowing about whether the patient's illness was caused by a particular antecedent of it; and prognosis - knowing about the patient's future health, including as to its dependence on the choice of treatment. Pivotal in gnostic clinical research this book presents to be the studies' objects design in terms of a statistical model for the rate of occurrence of the entity of health in question, in a defined domain of case presentations. The essentials of the studies' methods designs are deduced from their objects designs. Study of this book - on the theory of "meta-epidemiological clinical research" - is essential preparation for teaching 'patient-oriented' clinical research and for actual design & conduct of the studies and of their critical reviews. And by the same token, study of this book is essential preparation for the needed replacement of 'case-based learning' of clinical medicine, for suitably-learned teaching of the practice of clinical medicine - focused on the status quo of the scientific knowledge-base for (gnoses in) the discipline ('specialty') at issue.

Author : Flora Hammond, MD,James Malec, PhD,Todd Nick,Ralph Buschbacher, MD
Publisher : Demos Medical Publishing
Page : 348 pages
File Size : 42,7 Mb
Release : 2014-08-26
Category : Medical
ISBN : 9781936287543

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Handbook for Clinical Research by Flora Hammond, MD,James Malec, PhD,Todd Nick,Ralph Buschbacher, MD Pdf

The majority of physicians are poorly knowledgeable about statistics and research design, yet are expected to do clinical research and write articles (if in academia) or, at the very least, to read the literature critically and provide evidence-based care to patients. The basic skills involved are touched on very minimally in residency, but not in enough depth for an untrained investigator to successfully design or conduct a study, or analyze research findings in any meaningful way. This volume is intended as a “quick fix”, allowing readers to look up information rapidly about various design types and statistical methods to see what the pros, cons, and indications for each are. Research implementation, including regulatory issues and grant writing, is also covered. The book is unique in physical medicine and rehabilitation, and with the increased emphasis on outcomes measurement and push toward a national agenda for disability research, will appeal both to investigators planning and executing studies and clinicians looking to better understand how the findings impact their practice. A list of topics with an outline of headings for each of the sections is attached.