Essential Concepts In Clinical Research

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Essential Concepts in Clinical Research

Kenneth Schulz,David A. Grimes
Essential Concepts in Clinical Research Book PDF

Author : Kenneth Schulz,David A. Grimes
Publisher : Elsevier Health Sciences
Page : 272 pages
File Size : 51,8 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

The Lancet Handbook of Essential Concepts in Clinical Research

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

Author : Kenneth F. Schulz,David A. Grimes
Publisher : Elsevier Health Sciences TW
Page : 248 pages
File Size : 55,8 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.

Essentials of Clinical Research

Stephen P. Glasser
Essentials of Clinical Research Book PDF

Author : Stephen P. Glasser
Publisher : Springer
Page : 461 pages
File Size : 41,7 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.

Design and Analysis of Clinical Trials

Shein-Chung Chow,Jen-Pei Liu
Design and Analysis of Clinical Trials Book PDF

Author : Shein-Chung Chow,Jen-Pei Liu
Publisher : Wiley-Interscience
Page : 680 pages
File Size : 52,9 Mb
Release : 1998-06-23
Category : Mathematics
ISBN : UOM:39015047055416

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Design and Analysis of Clinical Trials by Shein-Chung Chow,Jen-Pei Liu Pdf

A unique, unifying treatment for statistics and science in clinical trials What sets this volume apart from the many books dealing with clinical trials is its integration of statistical and clinical disciplines. Stressing communication between biostatisticians and clinical scientists, this work clearly relates statistical interpretation to clinical issues arising in different stages of pharmaceutical research and development. Plus, the principles presented here are universal enough to be easily adapted in non-biopharmaceutical settings. Design and Analysis of Clinical Trials tackles concepts and methodologies. It not only covers statistical basics such as uncertainty and bias, design considerations such as patient selection, randomization, and the different types of clinical trials but also deals with various methods of data analysis, group sequential procedures for interim analysis, efficacy data evaluation, analysis of safety data, and more. Throughout, the book: * Surveys current and emerging clinical issues and newly developed statistical methods * Presents a critical review of statistical methodologies in various therapeutic areas * Features case studies from actual clinical trials * Minimizes the mathematics involved, making the material widely accessible * Offers each chapter as a self-contained entity * Includes illustrations to highlight the text This monumental reference on all facets of clinical trials is important reading for physicians, clinical and medical researchers, pharmaceutical scientists, clinical programmers, biostatisticians, and anyone involved in this burgeoning area of clinical research. It can also be used as a textbook in graduate-level courses in the field.

Designing Clinical Research

Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman
Designing Clinical Research Book PDF

Author : Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman
Publisher : Lippincott Williams & Wilkins
Page : 388 pages
File Size : 43,5 Mb
Release : 2011-11-30
Category : Medical
ISBN : 9781451165852

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Designing Clinical Research by Stephen B. Hulley,Steven R. Cummings,Warren S. Browner,Deborah G. Grady,Thomas B. Newman Pdf

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology—including molecular and genetic clinical research—and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.

A Text Book of Clinical Pharmacy Practice

G. Parthasarathi,Karin Nyfort-Hansen,Milap C. Nahata
A Text Book of Clinical Pharmacy Practice Book PDF

Author : G. Parthasarathi,Karin Nyfort-Hansen,Milap C. Nahata
Publisher : Orient Blackswan
Page : 520 pages
File Size : 49,5 Mb
Release : 2004
Category : Clinical pharmacology
ISBN : 8125026312

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A Text Book of Clinical Pharmacy Practice by G. Parthasarathi,Karin Nyfort-Hansen,Milap C. Nahata Pdf

The Majority Of Clinical Pharmacy Textbooks Focus On Disease States And Applied Therapeutics. This Book Is Different. It Aims To Provide Readers With A Comprehensive Description Of The Concepts And Skills That Are The Foundation For Current Clinical Pharmacy Practice. It Seeks To Answer The Question How Do Clinical Pharmacists Practice? Rathar Than What Do Clinical Pharmacists Need To Know About Drugs And Therapeutics? The Book Is Divided Into Three Sections, And Each Chapter Is Self-Contained And Can Be Read Independently. Section I Provides An Overview Of The Current Status Of Clinical Pharmacy Practice In India And Other Countries. Section Ii Includes Chapters On The Key Concepts, Skills And Competencies Required For Effective Clinical Practice. Section Iii Covers Topics Of Interest To Graduate And Postgraduate Students, And More Experienced Clinical Pharmacists And Researchers.This Book Will Be Useful For All Students Of Pharmacy And Pharmacists Working In Hospital Pharmacy, Community Pharmacy, Drug Or Medical Information, Clinical Research, Government And Nongovernment Organisations, Teaching And Research.

Clinical Research Informatics

Rachel Richesson,James Andrews
Clinical Research Informatics Book PDF

Author : Rachel Richesson,James Andrews
Publisher : Springer Science & Business Media
Page : 415 pages
File Size : 48,5 Mb
Release : 2012-02-15
Category : Medical
ISBN : 9781848824478

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Clinical Research Informatics by Rachel Richesson,James Andrews Pdf

The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.

Small Clinical Trials

Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Small Clinical Trials Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Page : 222 pages
File Size : 42,5 Mb
Release : 2001-01-01
Category : Medical
ISBN : 0309171148

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Small Clinical Trials by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials Pdf

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Clinical Trials in Neurology

Felipe Fregni
Clinical Trials in Neurology Book PDF

Author : Felipe Fregni
Publisher : Humana Press
Page : 616 pages
File Size : 41,9 Mb
Release : 2018-07-31
Category : Medical
ISBN : 1493978799

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Clinical Trials in Neurology by Felipe Fregni Pdf

This volume provides in-depth descriptions and discussion of clinical trial designs based on novel data analysis of high-quality trials for 11 different neurological conditions in order to ultimately improve the quality of care in neurology. Some of the conditions discussed in this book are stroke, traumatic brain injury, Alzheimer’s disease, epilepsy, and tumors of the central nervous system. In Neuromethods series style, chapters include the kind of detail and key advice from the specialists needed to get successful results in your research center and clinical investigation. Thorough and comprehensive, Clinical Trials in Neurology is a valuable guide for individuals in the research, education, and clinical practice fields, specifically in the fields of medicine, physical therapy, occupational therapy, nursing, and public health. This volume is also an important resource for clinicians aiming to improve their understanding in methodology of clinical trials.

Basic Concepts of Clinical Electrophysiology in Audiology

John D. Durrant,Cynthia G. Fowler,John A. Ferraro,Suzanne C. Purdy
Basic Concepts of Clinical Electrophysiology in Audiology Book PDF

Author : John D. Durrant,Cynthia G. Fowler,John A. Ferraro,Suzanne C. Purdy
Publisher : Plural Publishing
Page : 505 pages
File Size : 49,7 Mb
Release : 2022-01-07
Category : Medical
ISBN : 9781635501797

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Basic Concepts of Clinical Electrophysiology in Audiology by John D. Durrant,Cynthia G. Fowler,John A. Ferraro,Suzanne C. Purdy Pdf

Basic Concepts of Clinical Electrophysiology in Audiology is a revolutionary textbook, combining the research and expertise of both distinguished experts and up-and-coming voices in the field. By taking a multidisciplinary approach to the subject, the editors of this graduate-level text break down all aspects of electrophysiology to make it accessible to audiology students. In addition to defining the basics of the tools of the trade and their routine uses, the authors also provide ample presentations of new approaches currently undergoing continuing research and development. The goal of this textbook is to give developing audiologists a broad and solid basis of understanding of the methods in common or promising practice. Throughout the text, individual chapters are divided into “episodes,” each examining a facet of the overarching chapter’s topic. With different experts handling each episode, readers are exposed to outstanding professionals in the field. This text singularly stitches together the chapters and their episodes to build from foundational concepts to more complex issues that clinicians are likely to face on their road to full clinical competency. As collections of episodes, the writers and editors thus endeavor to present a series of stories that build throughout the book, in turn allowing readers to build a broader interest in the subject. Key Features * Heads Up sections in each chapter introduce more advanced content to expose readers to what lies beyond the basic level and further enhance the main chapter content and “entertainment value” * Take home messages at the end of each chapter serve to focus the reader’s attention, encourage review, and discourage superficial learning by “just reading the abstract” * More than 450 innovative illustrations use combinations of panels, insets, and/or gray tone to facilitate reader understanding, optimize portrayal of data, and unify concepts across chapters * Numerous case studies and references to practical clinical issues and results are included throughout the book * Keywords are highlighted in-text to improve both attention and retention of critical terms and ease of returning to review them

Key Concepts in Medical Sociology

Jonathan Gabe,Michael Bury,Mary Ann Elston
Key Concepts in Medical Sociology Book PDF

Author : Jonathan Gabe,Michael Bury,Mary Ann Elston
Publisher : SAGE
Page : 278 pages
File Size : 41,6 Mb
Release : 2004-04-10
Category : Medical
ISBN : 0761974423

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Key Concepts in Medical Sociology by Jonathan Gabe,Michael Bury,Mary Ann Elston Pdf

This title provides a systematic and accessible introduction to medical sociology, beginning each 1500 word entry with a definition of the concept, then examines its origins, development, strengths and weaknesses, offering further reading guidance for independent learning, and drawing on international literature and examples.

Ethical Conduct of Clinical Research Involving Children

Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Ethical Conduct of Clinical Research Involving Children Book PDF

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 54,7 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Fundamentals of Clinical Trials

Lawrence M. Friedman,Curt Furberg,David L. DeMets
Fundamentals of Clinical Trials Book PDF

Author : Lawrence M. Friedman,Curt Furberg,David L. DeMets
Publisher : Springer Science & Business Media
Page : 384 pages
File Size : 52,7 Mb
Release : 1998
Category : Clinical trials
ISBN : 0387985867

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

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

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 : 55,8 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.

Strategy and Statistics in Clinical Trials

Joseph Tal
Strategy and Statistics in Clinical Trials Book PDF

Author : Joseph Tal
Publisher : Academic Press
Page : 279 pages
File Size : 52,8 Mb
Release : 2011-07-14
Category : Mathematics
ISBN : 9780123869098

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Strategy and Statistics in Clinical Trials by Joseph Tal Pdf

Delineates the statistical building blocks and concepts of clinical trials.