Designing Clinical Research

Designing Clinical Research Author Stephen B. Hulley
ISBN-10 9781469840543
Release 2013-05-08
Pages 378
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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 product 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.



Designing Clinical Research

Designing Clinical Research Author Dr Stephen B Hulley, MD, MPH
ISBN-10 1469875330
Release 2015-04-27
Pages 381
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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.



Planning and Designing Clinical Research

Planning and Designing Clinical Research Author S.B. Martins
ISBN-10 9788847029194
Release 2013-04-18
Pages 48
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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.



Designing Clinical Research An Epidemiologic Approach

Designing Clinical Research   An Epidemiologic Approach Author CTI Reviews
ISBN-10 9781467223355
Release 2016-10-16
Pages 57
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Facts101 is your complete guide to Designing Clinical Research , An Epidemiologic Approach. In this book, you will learn topics such as as those in your book plus much more. With key features such as key terms, people and places, Facts101 gives you all the information you need to prepare for your next exam. Our practice tests are specific to the textbook and we have designed tools to make the most of your limited study time.



Simulation for Designing Clinical Trials

Simulation for Designing Clinical Trials Author Hui Kimko
ISBN-10 0203910273
Release 2002-12-12
Pages 424
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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.



Publishing and Presenting Clinical Research

Publishing and Presenting Clinical Research Author Warren S. Browner
ISBN-10 9781451115901
Release 2012-03-19
Pages 224
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Publishing and Presenting Clinical Research, Fourth Edition is an excellent primer for investigators who wish to learn how to organize, present, and publish results of their research. Written by an experienced clinical researcher and editor, it uses hundreds of examples, tables and figures to show how to produce successful abstracts, posters, oral presentations, and manuscripts for publication. This book also serves as a companion to the popular text, Designing Clinical Research. This edition contains the latest: • Guidance on getting work accepted in medical journals and at scientific meetings • Examples of the do’s and don’ts of data presentation • Explanations of confusing statistical terminology • Templates to get started and avoid writers’ block • Tips for creating simple graphics and tables • Help for those who are not fluent in English • Suggestions about getting the most from a poster session • Checklists for each section of a manuscript or presentation • Advice about authorship and responding to reviewers’ comments Plus with this edition, there is access to a companion website with fully searchable text so you can access the content anytime, anywhere.



Oncology Clinical Trials

Oncology Clinical Trials Author Susan Halabi, PhD
ISBN-10 1935281763
Release 2009-12-22
Pages 168
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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



Concise Guide to Evidence Based Psychiatry

Concise Guide to Evidence Based Psychiatry Author Gregory E. Gray
ISBN-10 1585626961
Release 2008-05-20
Pages 264
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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.



Clinical Trial Designing A Primer

Clinical Trial Designing  A Primer Author Kanosia
ISBN-10 1514837560
Release 2015-07-05
Pages 42
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This book is an excellent primer for learners who are in the business of clinical research and trial industry. Clinical Research Designing is an important phases of clinical research study. There are various aspects needed to be taken care while designing clinical trials. Key Features are; -What is Clinical Research & Clinical Trials? -What are the basic requirements for designing the Clinical Trials? -Different Phases of Clinical Trials -What is Blinding -What is Randomization -What is placebo -What are additional design considerations? Clinical Trial Designing is the key phenomenon in performing clinical research. All the required information related with proving safety & efficacy of the Medicinal new product (investigational new drug) should be captured while designing Clinical Trials (CT). Drug regulations laws, require submission of lot of regulatory documents to give approval for marketing the new drugs -and this is possible only if the clinical trials are successful and further this is possible only with good clinical trial designing.



Developments in Statistical Evaluation of Clinical Trials

Developments in Statistical Evaluation of Clinical Trials Author Kees van Montfort
ISBN-10 9783642553455
Release 2014-10-07
Pages 361
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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.



Intervention Research

Intervention Research Author Bernadette Mazurek Melnyk, PhD, RN, CPNP/ PMHNP, FNAP, FAAN
ISBN-10 9780826109583
Release 2012-04-23
Pages 496
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2012 First Place AJN Book of the Year Award Winner in Nursing Research! "This is a resource for success and should be a part of any researcher's library."--Doody's Medical Reviews This book is a practical, user-friendly guide for health care researchers across multiple disciplines who are involved in intervention research. It provides all of the essential elements needed for understanding how to design, conduct, analyze, and fund intervention studies that are replicable and can withstand the scrutiny of the Institutional Review Board and peer review. Developed from an annual continuing education workshop on intervention studies conducted by Dr. Melnyk, this text is the most comprehensive body of information available on this topic. Contributors address the design of interventions that are ethically considerate and sensitive to culture, race/ethnicity, and gender, minimizing threats to external and internal validity, measurement, and budgeting. The guide explores such implementation issues as subject recruitment and retention, data management, and specialized settings, cost analysis, and explaining intervention effects. The text also guides readers in writing grant applications that fund , and addresses how to move intervention study findings into the real world. A unique addition to the book is the availability of digital examples of progress reports, final reports, and research grant applications that have received funding from the National Institutes of Health and other relevant organizations. This text is a valuable resource for all health care professionals conducting research and for doctoral students in health care studies. Key Features: Presents the essential tools for designing, conducting, analyzing, and funding intervention studies Designed for use by health care professionals conducting intervention research Provides comprehensive, accessible guidelines for doctoral students across all health care disciplines Instructs readers on writing grant applications that fund Includes digital examples of funded research grants, progress reports, and final reports



Clinical Trial Simulations

Clinical Trial Simulations Author Holly H. C. Kimko
ISBN-10 1441974156
Release 2010-12-09
Pages 540
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This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.



Success in Academic Surgery Clinical Trials

Success in Academic Surgery  Clinical Trials Author Timothy M. Pawlik
ISBN-10 9781447146797
Release 2013-11-04
Pages 183
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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.



Practical Statistics for Medical Research

Practical Statistics for Medical Research Author Douglas G. Altman
ISBN-10 0412276305
Release 1990-11-22
Pages 624
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Most medical researchers, whether clinical or non-clinical, receive some background in statistics as undergraduates. However, it is most often brief, a long time ago, and largely forgotten by the time it is needed. Furthermore, many introductory texts fall short of adequately explaining the underlying concepts of statistics, and often are divorced from the reality of conducting and assessing medical research. Practical Statistics for Medical Research is a problem-based text for medical researchers, medical students, and others in the medical arena who need to use statistics but have no specialized mathematics background. The author draws on twenty years of experience as a consulting medical statistician to provide clear explanations to key statistical concepts, with a firm emphasis on practical aspects of designing and analyzing medical research. The text gives special attention to the presentation and interpretation of results and the many real problems that arise in medical research.



Clinical Research for the Doctor of Nursing Practice

Clinical Research for the Doctor of Nursing Practice Author Allison J. Terry
ISBN-10 9780763791223
Release 2011-05-27
Pages 511
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Clinical Research for the Doctor of Nursing Practice is a user-friendly guide that offers DNP students a step-by-step method to implement clinically-based research. Designed specifically for DNP-level research courses, this text introduces a streamlined approach that emphasizes crucial information while eliminating extraneous material. Each chapter addresses specific areas that pertain to the DNP student, such as designing and implementing the Capstone Project, and includes features such as learning enhancement tools, resources for further study, learning objectives, and a glossary. Key chapters on Mixed Methods Research and Survey Research are also included making this text an essential resource for the DNP student.



Principles of Research Design and Drug Literature Evaluation

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-10 9781449691318
Release 2014-03-01
Pages 375
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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"



Clinical Trial Design Challenges in Mood Disorders

Clinical Trial Design Challenges in Mood Disorders Author Mauricio Tohen
ISBN-10 9780124051768
Release 2015-01-24
Pages 192
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Poor clinical trial designs result in failed studies wasting research funds and limiting the advancement of cures for disorders. Clinical Trial Design Challenges in Mood Disorders outlines classic problems researchers face in designing clinical trials and discusses how best to address them for the most definitive and generalizable results. Traditional trial designs are included as well as novel analytic techniques. The book examines information on high placebo response, the generalizability of studies conducted in the developing world, the duration of maintenance studies, and the application of findings into clinical practice. With representation from contributors throughout the world and from academia, industry, regulatory agencies, and advocacy groups, this book will contribute toward improved clinical trial design and valid, precise, and reliable answers about what works better and faster for patients. Summarizes common trial design problems and their solutions Encompasses funding, subject selection, regulatory issues and more Identifies best practices for definitive and generalizable results Includes traditional trial designs and novel analytic techniques Represents academia, industry, regulatory agencies, and advocacy groups