Designing Clinical Research

Designing Clinical Research Author Stephen B. Hulley
ISBN-10 9781469840543
Release 2013-05-08
Pages 378
Download Link Click Here

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 Stephen B. Hulley
ISBN-10 9781451165852
Release 2011-11-30
Pages 384
Download Link Click Here

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.



Designing Clinical Research

Designing Clinical Research Author Stephen B. Hulley
ISBN-10 0781782104
Release 2007
Pages 367
Download Link Click Here

This third edition 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 and offers an updated syllabus for conducting a clinical research workshop.



Designing Clinical Research

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

"This book provides a practical guide to planning, tabulating, formulating, and implementing clinical research, in an easy-to-use, readable presentation"--Provided by publisher.



Simulation for Designing Clinical Trials

Simulation for Designing Clinical Trials Author Hui Kimko
ISBN-10 0203910273
Release 2002-12-12
Pages 424
Download Link Click Here

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.



Principles and Practice of Clinical Research

Principles and Practice of Clinical Research Author John I. Gallin
ISBN-10 9780128499047
Release 2017-11-17
Pages 824
Download Link Click Here

Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting



Publishing and Presenting Clinical Research

Publishing and Presenting Clinical Research Author Warren S. Browner
ISBN-10 9781451115901
Release 2012-03-19
Pages 224
Download Link Click Here

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.



Design and Analysis of Clinical Trials

Design and Analysis of Clinical Trials Author Shein-Chung Chow
ISBN-10 9780471473299
Release 2008-12-04
Pages 752
Download Link Click Here

Design and Analysis of Clinical Trials has been writing in one form or another for most of life. You can find so many inspiration from Design and Analysis of Clinical Trials also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Design and Analysis of Clinical Trials book for free.



Clinical Trials

Clinical Trials Author Tom Brody
ISBN-10 9780128042588
Release 2016-02-19
Pages 896
Download Link Click Here

Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers



Writing Clinical Research Protocols

Writing Clinical Research Protocols Author Evan DeRenzo
ISBN-10 0080454208
Release 2005-09-08
Pages 320
Download Link Click Here

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations



Fundamentals of Clinical Trials

Fundamentals of Clinical Trials Author Lawrence M. Friedman
ISBN-10 9783319185392
Release 2015-08-27
Pages 550
Download Link Click Here

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.



Strategy and Statistics in Clinical Trials

Strategy and Statistics in Clinical Trials Author Joseph Tal
ISBN-10 9780123869098
Release 2011
Pages 267
Download Link Click Here

Strategy and Statistics in Clinical Trials is for all individuals engaged in clinical research, including professors, physicians, researchers in corporate and government laboratories, nurses, members of the allied health professions, and post-doctoral and graduate students who are potentially less exposed to understanding the pivotal role of statistics. . Enables nonstatisticians to better understand research processes and statistics' role in these processes . Offers real-life case studies and provides a practical, "how to" guide to biomedical R&D . Delineates the statistical building blocks and concepts of clinical trials . Promotes effective cooperation between statisticians and important other parties.



Clinical Trials

Clinical Trials Author Steven Piantadosi
ISBN-10 9781118959213
Release 2017-10-09
Pages 896
Download Link Click Here

Presents elements of clinical trial methods that are essential in planning, designing, conducting, analyzing, and interpreting clinical trials with the goal of improving the evidence derived from these important studies This Third Edition builds on the text’s reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the principles of design for various types of clinical trials, and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides common sense solutions. All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The authors bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development, comparative studies, and adaptive designs. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second Editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections. In addition, this book: • Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research -- now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs • Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods • Contains an introduction and summary in each chapter to reinforce key points • Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge • Provides extensive references to direct readers to the most recent literature, and there are numerous new or revised exercises throughout the book Clinical Trials: A Methodologic Perspective, Third Edition is a textbook accessible to advanced undergraduate students in the quantitative sciences, graduate students in public health and the life sciences, physicians training in clinical research methods, and biostatisticians and epidemiologists. Steven Piantadosi, MD, PhD, is the Phase One Foundation Distinguished Chair and Director of the Samuel Oschin Cancer Institute, and Professor of Medicine at Cedars-Sinai Medical Center in Los Angeles, California. Dr. Piantadosi is one of the world’s leading experts in the design and analysis of clinical trials for cancer research. He has taught clinical trials methods extensively in formal courses and short venues. He has advised numerous academic programs and collaborations nationally regarding clinical trial design and conduct, and has served on external advisory boards for the National Institutes of Health and other prominent cancer programs and centers. The author of more than 260 peer-reviewed scientific articles, Dr. Piantadosi has published extensively on research results, clinical applications, and trial methodology. While his papers have contributed to many areas of oncology, he has also collaborated on diverse studies outside oncology including lung disease and degenerative neurological disease.



Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children Author Institute of Medicine
ISBN-10 0309133386
Release 2004-07-09
Pages 445
Download Link Click Here

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.



Designing Clinical Research An Epidemiologic Approach

Designing Clinical Research   An Epidemiologic Approach Author CTI Reviews
ISBN-10 9781467223355
Release 2016-10-16
Pages 57
Download Link Click Here

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.



Clinical Epidemiology

Clinical Epidemiology Author R. Brian Haynes
ISBN-10 9781451178791
Release 2012-03-29
Pages 480
Download Link Click Here

The Third Edition of this popular text focuses on clinical-practice research methods. It is written by clinicians with experience in generating and answering researchable questions about real-world clinical practice and health care—the prevention, treatment, diagnosis, prognosis, and causes of diseases, the measurement of quality of life, and the effects of innovations in health services. The book has a problem-oriented and protocol-based approach and is written at an introductory level, emphasizing key principles and their applications. A bound-in CD-ROM contains the full text of the book to help the reader locate needed information.



Intervention Research

Intervention Research Author Bernadette Mazurek Melnyk, PhD, RN, CPNP/ PMHNP, FNAP, FAAN
ISBN-10 9780826109583
Release 2012-04-23
Pages 496
Download Link Click Here

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