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Designing Clinical Research

Author : Stephen B. Hulley
ISBN : 9781451165852
Genre : Medical
File Size : 82.69 MB
Format : PDF, Kindle
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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.
Category: Medical

Designing Clinical Research

Author : Dr Stephen B Hulley, MD, MPH
ISBN : 1469875330
Genre : Clinical trials
File Size : 68.91 MB
Format : PDF, ePub
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"This book provides a practical guide to planning, tabulating, formulating, and implementing clinical research, in an easy-to-use, readable presentation"--Provided by publisher.
Category: Clinical trials

Planning And Designing Clinical Research

Author : S.B. Martins
ISBN : 9788847029194
Genre : Medical
File Size : 57.99 MB
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This manuscript is an introduction to the design and planning of clinical research. Practical issues are covered with a theoretical background. The refinement of a research question, searching and critically appraising the literature and management of references are discussed. Ethical concerns are raised throughout the development of the study protocol. Study designs are described and special emphasis is given to writing a protocol of a clinical trial. Sample selection and recruitment, variable measurement, randomization, follow up, statistical analysis, sample size and bias are covered. Tips on how to successfully write and publish the research report are provided.
Category: Medical

Simulation For Designing Clinical Trials

Author : Hui Kimko
ISBN : 0203910273
Genre : Medical
File Size : 34.90 MB
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Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to clinical trial designs according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the population relationship between dosing schedules and patient response.
Category: Medical

Designing And Conducting Clinical Trials An Overview

Author : Editor IJSMI
ISBN : 9781096489085
Genre : Medical
File Size : 76.61 MB
Format : PDF
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Clinical trials can be defined as an experiment which is conducted in a controlled environment to test the efficacy of drugs, procedures, methodology before bringing into the public domain. The clinical trials started in 2nd century BC by Daniel & King Nebuchadnezzar. Formal recorded therapeutic clinical trial was started way back in 1537 AD by a Surgeon. Current clinical trials include clear guidelines, adhering to regulatory requirements, getting consent from the patients, ensuring safety of the patients, adopting ethical practices, close monitoring of the trials and using advanced statistical tools to analyze and report the findings. Advancement in technology such as cloud computing, big data analytics, machine learning algorithms, data base management and advanced statistical software helped to transform the different stages of clinical trials - the data collection, data storage, data monitoring, data management and data analysis. This book provides an overview of clinical trials, different phases & types of clinical trial, randomization, blinding, allocation, ethical issues, protocol, data collection forms, data management, data analysis and reporting of the clinical trial. It is recommended to refer author’s book on Application of Statistical Tools in Biomedical Domain: An Overview with Help of Software ( and Essentials of Bio-Statistics: An overview with the help of Software if you need to familiarize yourself with the basic statistical knowledge.
Category: Medical

Oncology Clinical Trials

Author : Susan Halabi, PhD
ISBN : 1935281763
Genre : Medical
File Size : 74.46 MB
Format : PDF, ePub, Mobi
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Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout
Category: Medical

Developments In Statistical Evaluation Of Clinical Trials

Author : Kees van Montfort
ISBN : 9783642553455
Genre : Mathematics
File Size : 44.83 MB
Format : PDF
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This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.
Category: Mathematics

Concise Guide To Evidence Based Psychiatry

Author : Gregory E. Gray
ISBN : 1585626961
Genre : Medical
File Size : 53.52 MB
Format : PDF, ePub
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Concise Guide to Evidence-Based Psychiatry (EBP) is a must-have resource for informed decision-making in psychiatric practice today. This single, easy-to-use reference will enable practitioners to find answers to clinical questions, critically appraise articles, and apply the results of their findings to patients. This practical handbook provides quick access to EBP theories, tools, and methods. Concise Guide to Evidence-Based Psychiatry is a one-stop reference for using the literature to improve patient outcomes. Features include: Practical -- Filled with how-to information, Concise Guide to Evidence-Based Psychiatry outlines the latest techniques for accessing, assessing, and interpreting the literature. Easy to use -- Includes many tables of essential websites for finding reliable information on the Internet, best-practice strategies for searching the medical literature. Concise Guide to Evidence-Based Psychiatry fills an important role as the first EBP text for teaching residents, who are now required to develop such skills to meet the ACGME "practice-based learning and improvement" core competency. Special features for pedagogical use include suggestions for teaching EBP in residency programs, profuse examples from the psychiatric literature, and worksheets for the critical appraisal of clinical trials, diagnostic tests, epidemiologic studies, studies of prognosis, and more. Whether for self-study or use in residency programs, Concise Guide to Evidence-Based Psychiatry is the best resource available to help practitioners apply current research findings to their work with patients.
Category: Medical

Principles Of Research Design And Drug Literature Evaluation

Author : Professor and Chair Department of Pharmaceutical Health Outcomes and Policy University of Houston College of Pharmacy Houston Texas Rajender R Aparasu, Ed.
ISBN : 9781449691318
Genre : Medical
File Size : 55.43 MB
Format : PDF, Docs
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Principles of Research Design and Drug Literature Evaluation is a unique resource that provides a balanced approach covering critical elements of clinical research, biostatistical principles, and scientific literature evaluation techniques for evidence-based medicine. This accessible text provides comprehensive course content that meets and exceeds the curriculum standards set by the Accreditation Council for Pharmacy Education (ACPE). Written by expert authors specializing in pharmacy practice and research, this valuable text will provide pharmacy students and practitioners with a thorough understanding of the principles and practices of drug literature evaluation with a strong grounding in research and biostatistical principles. Principles of Research Design and Drug Literature Evaluation is an ideal foundation for professional pharmacy students and a key resource for pharmacy residents, research fellows, practitioners, and clinical researchers. FEATURES * Chapter Pedagogy: Learning Objectives, Review Questions, References, and Online Resources * Instructor Resources: PowerPoint Presentations, Test Bank, and an Answer Key * Student Resources: a Navigate Companion Website, including Crossword Puzzles, Interactive Flash Cards, Interactive Glossary, Matching Questions, and Web Links From the Foreword: "This book was designed to provide and encourage practitioner s development and use of critical drug information evaluation skills through a deeper understanding of the foundational principles of study design and statistical methods. Because guidance on how a study s limited findings should not be used is rare, practitioners must understand and evaluate for themselves the veracity and implications of the inherently limited primary literature findings they use as sources of drug information to make evidence-based decisions together with their patients. The editors organized the book into three supporting sections to meet their pedagogical goals and address practitioners needs in translating research into practice. Thanks to the editors, authors, and content of this book, you can now be more prepared than ever before for translating research into practice." L. Douglas Ried, PhD, FAPhA Editor-in-Chief Emeritus, Journal of the American Pharmacists Association Professor and Associate Dean for Academic Affairs, College of Pharmacy, University of Texas at Tyler, Tyler, Texas"
Category: Medical