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Essential Concepts In Clinical Research
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Book Synopsis Essential Concepts in Clinical Research by : Kenneth Schulz
Download or read book Essential Concepts in Clinical Research written by Kenneth Schulz and published by Elsevier Health Sciences. This book was released on 2018-07-19 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. For this Second Edition, the authors have revised and updated the original 16 chapters and added six new chapters. For busy clinicians and active researchers interested in research methods, this book provides helpful tools to derive satisfaction - indeed, fun - from clinical science.
Book Synopsis The Lancet Handbook of Essential Concepts in Clinical Research by : Kenneth F. Schulz
Download or read book The Lancet Handbook of Essential Concepts in Clinical Research written by Kenneth F. Schulz and published by . This book was released on 2006 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: The needs of clinicians predominate throughout the text, but these needs overlap with those of researchers especially in chapters covering randomized controlled trials. For readers to assess trials accurately they need to understand relevant guidelines on the conduct of trials that are emerging from methodological research. In presenting these discussions to clinicians these chapters will help researchers who also do randomized trials and provide a methodological background that enhances the quality and quantity of their research productivity.
Book Synopsis Essentials of Clinical Research by : Stephen P. Glasser
Download or read book Essentials of Clinical Research written by Stephen P. Glasser and published by Springer. This book was released on 2014-06-02 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Small Clinical Trials by : Institute of Medicine
Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Designing Clinical Research by : Stephen B. Hulley
Download or read book Designing Clinical Research written by Stephen B. Hulley and published by Lippincott Williams & Wilkins. This book was released on 2011-11-30 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council
Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Clinical Epidemiology by : Robert Fletcher
Download or read book Clinical Epidemiology written by Robert Fletcher and published by Lippincott Williams & Wilkins. This book was released on 2013-01-08 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now in its Fifth Edition, Clinical Epidemiology: The Essentials is a comprehensive, concise, and clinically oriented introduction to the subject of epidemiology. Written by expert educators, this text introduces students to the principles of evidence-based medicine that will help them develop and apply methods of clinical observation in order to form accurate conclusions. The Fifth Edition includes more complete coverage of systematic reviews and knowledge management, as well as other key topics such as abnormality, diagnosis, frequency and risk, prognosis, treatment, prevention, chance, studying cases and cause.
Book Synopsis A Text Book of Clinical Pharmacy Practice by : G. Parthasarathi
Download or read book A Text Book of Clinical Pharmacy Practice written by G. Parthasarathi and published by Orient Blackswan. This book was released on 2004 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Basic Science Methods for Clinical Researchers by : Morteza Jalali
Download or read book Basic Science Methods for Clinical Researchers written by Morteza Jalali and published by Academic Press. This book was released on 2017-03-31 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Science Methods for Clinical Researchers addresses the specific challenges faced by clinicians without a conventional science background. The aim of the book is to introduce the reader to core experimental methods commonly used to answer questions in basic science research and to outline their relative strengths and limitations in generating conclusive data. This book will be a vital companion for clinicians undertaking laboratory-based science. It will support clinicians in the pursuit of their academic interests and in making an original contribution to their chosen field. In doing so, it will facilitate the development of tomorrow's clinician scientists and future leaders in discovery science. - Serves as a helpful guide for clinical researchers who lack a conventional science background - Organized around research themes pertaining to key biological molecules, from genes, to proteins, cells, and model organisms - Features protocols, techniques for troubleshooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data - Appendices provide resources for practical research methodology, including legal frameworks for using stem cells and animals in the laboratory, ethical considerations, and good laboratory practice (GLP)
Book Synopsis Bayesian Approaches to Clinical Trials and Health-Care Evaluation by : David J. Spiegelhalter
Download or read book Bayesian Approaches to Clinical Trials and Health-Care Evaluation written by David J. Spiegelhalter and published by John Wiley & Sons. This book was released on 2004-01-16 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: READ ALL ABOUT IT! David Spiegelhalter has recently joined the ranks of Isaac Newton, Charles Darwin and Stephen Hawking by becoming a fellow of the Royal Society. Originating from the Medical Research Council’s biostatistics unit, David has played a leading role in the Bristol heart surgery and Harold Shipman inquiries. Order a copy of this author’s comprehensive text TODAY! The Bayesian approach involves synthesising data and judgement in order to reach conclusions about unknown quantities and make predictions. Bayesian methods have become increasingly popular in recent years, notably in medical research, and although there are a number of books on Bayesian analysis, few cover clinical trials and biostatistical applications in any detail. Bayesian Approaches to Clinical Trials and Health-Care Evaluation provides a valuable overview of this rapidly evolving field, including basic Bayesian ideas, prior distributions, clinical trials, observational studies, evidence synthesis and cost-effectiveness analysis. Covers a broad array of essential topics, building from the basics to more advanced techniques. Illustrated throughout by detailed case studies and worked examples Includes exercises in all chapters Accessible to anyone with a basic knowledge of statistics Authors are at the forefront of research into Bayesian methods in medical research Accompanied by a Web site featuring data sets and worked examples using Excel and WinBUGS - the most widely used Bayesian modelling package Bayesian Approaches to Clinical Trials and Health-Care Evaluation is suitable for students and researchers in medical statistics, statisticians in the pharmaceutical industry, and anyone involved in conducting clinical trials and assessment of health-care technology.
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Essential Concepts of Nursing by : John R. Cutcliffe
Download or read book The Essential Concepts of Nursing written by John R. Cutcliffe and published by Elsevier Health Sciences. This book was released on 2005-01-01 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the first time, leading authorities come together to offer their expertise as they present the building blocks and concepts of nursing theory. Provides an explanation of concepts necessary as building block of theoryResearch basedDraws extensively on literatureExperienced contributors and editors, all leading experts in their fields
Book Synopsis Strategy and Statistics in Clinical Trials by : Joseph Tal
Download or read book Strategy and Statistics in Clinical Trials written by Joseph Tal and published by Academic Press. This book was released on 2011-07-14 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Delineates the statistical building blocks and concepts of clinical trials.
Book Synopsis Clinical Research Informatics by : Rachel Richesson
Download or read book Clinical Research Informatics written by Rachel Richesson and published by Springer Science & Business Media. This book was released on 2012-02-15 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The Role of Purchasers and Payers in the Clinical Research Enterprise by : Institute of Medicine
Download or read book The Role of Purchasers and Payers in the Clinical Research Enterprise written by Institute of Medicine and published by National Academies Press. This book was released on 2002-06-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
Book Synopsis Clinical Pharmacy Education, Practice and Research by : Dixon Thomas
Download or read book Clinical Pharmacy Education, Practice and Research written by Dixon Thomas and published by Elsevier. This book was released on 2018-11-23 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. - Covers the core information needed for pharmacy practice courses - Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge - Designed for educational settings, but also useful as a refresher for advanced students and researchers
