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Clinical Trials

Clinical Trials Book
Author : Duolao Wang,Ameet Bakhai
Publisher : Remedica
Release : 2006
ISBN : 1901346722
Language : En, Es, Fr & De

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Book Description :

This book aims to demystify clinical trials. It is divided into five sections: fundamentals of trial design, alternative trial designs, basics of statistical analysis, special trial issues in data analysis, and reporting of trials. Using simple language the book explains with illustrations of numerous trial examples, the conceptual and methodological issues that occur at all stages of clinical trial covering trial design, conduct, analysis and reporting. The book is an educational and approachable reference in a difficult area of medicine where clinicians often feel uncertain and this material helps them review, appraise and publish trials and clinical evidence.

Fundamentals of Clinical Trials

Fundamentals of Clinical Trials Book
Author : Lawrence M. Friedman,Curt D. Furberg,David L. DeMets
Publisher : Springer Science & Business Media
Release : 2010-09-09
ISBN : 9781441915863
Language : En, Es, Fr & De

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Book Description :

The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.

Chemoprevention Clinical Trials

Chemoprevention Clinical Trials Book
Author : Anonim
Publisher : Unknown
Release : 1985
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Chemoprevention Clinical Trials book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Workshop on the Role of Computers in Cancer Clinical Trials

Workshop on the Role of Computers in Cancer Clinical Trials Book
Author : Anonim
Publisher : Unknown
Release : 1983
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Workshop on the Role of Computers in Cancer Clinical Trials book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Assessing Quality of Life in Clinical Trials

Assessing Quality of Life in Clinical Trials Book
Author : Peter M. Fayers,Ron Hays,Ron D. Hays
Publisher : Oxford University Press, USA
Release : 2005
ISBN : 9780198527695
Language : En, Es, Fr & De

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Book Description :

Researchers in all clinical fields are fully aware of the importance of Quality of Life measurements in judging the efficacy of a given treatment. Psychological criteria play an important role in this evaluation. This volulme explores the current state of the art and illustrates the benefits and potential of health related quality of life assessment in clinical trials. It covers a wide range of analytical issues, emphasizing new and innovative approaches that are of practical and clinical importance.

Clinical Trials in Psychiatry

Clinical Trials in Psychiatry Book
Author : Brian S. Everitt,Simon Wessely
Publisher : John Wiley & Sons
Release : 2008-04-15
ISBN : 9780470723845
Language : En, Es, Fr & De

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Book Description :

At last – a new edition of the highly acclaimed book Clinical Trials in Psychiatry This book provides a concise but thorough overview of clinical trials in psychiatry, invaluable to those seeking solutions to numerous problems relating to design, methodology and analysis of such trials. Practical examples and applications are used to ground theory whenever possible. The Second Edition includes new information regarding: Recent important psychiatric trials More specific discussion of psychiatry in the USA and the particular problems of trials in the USA, including comments about the FDA (U.S. Food and Drug Administration) An extended chapter on meta-analysis Further discussion of sub-group analysis Special features include appendices outlining how to design and report clinical trials, what websites and software programs are appropriate and an extensive reference section. From the reviews of the First Edition: “Everitt & Wessely are to be congratulated on producing an excellent guide to help overcome the snags in clinical trial research. Clearly written and in an engrossing style, the book is likely to become a classic textbook on clinical trials, and not just in psychiatry. The authors’ enthusiasm and grasp of clinical trial research make for a gripping and insightful read...it is one of the very best books that has been written on clinical trials.” THE BRITISH JOURNAL OF PSYCHIATRY "The experience of both authors in this area gives the book a very pragmatic approach grounded in reality, with theoretical overviews invariably being followed by practical examples and applications... an invaluable companion to anyone involved in, or contemplating undertaking, clinical trials research.” PSYCHOLOGICAL MEDICINE

Clinical Trials in Oncology Third Edition

Clinical Trials in Oncology  Third Edition Book
Author : Stephanie Green,Jacqueline Benedetti,Angela Smith
Publisher : CRC Press
Release : 2012-05-09
ISBN : 143981449X
Language : En, Es, Fr & De

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Book Description :

Studies that are unimpeachably thorough, non-political, unbiased, and properly designed... These are the standards to which everyone in clinical research aspires. Yet, the difficulties in designing trials and interpreting data are subtle and ever present. The new edition of Clinical Trials in Oncology provides a concise, nontechnical, and now thoroughly up-to-date review of methods and issues related to clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the major pitfalls that are seemingly inherent in these processes. This edition includes a new section that describes recent innovations in Phase I designs. Another new section on microarray data examines the challenges presented by massive data sets and describes approaches used to meet those challenges. As always, the authors use clear, lucid prose and a multitude of real-world trials as examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Although the book focuses on cancer trials, the issues and concepts are important in any clinical setting. Clinical Trials in Oncology, Second Edition works to improve the mutual understanding by clinicians and statisticians of the principles of clinical trials and helps them avoid the many hazards that can jeopardize the success of a trial.

Clinical Trials

Clinical Trials Book
Author : Curtis L. Meinert,Susan Tonascia
Publisher : Oxford University Press, USA
Release : 1986
ISBN : 9780195035681
Language : En, Es, Fr & De

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Book Description :

The definitive reference work on clinical trials, this book presents a wealth of detailed, practical information on the design, conduct, and analysis of both single center and multicenter trials. No other book on clinical trials offers as much detail as Meinert does on such issues as samplesize calculation, stratification and randomization, data systems design, consent form development, publication policies, preparation of funding requests, and reporting procedures.

Insurance in Clinical Trials

Insurance in Clinical Trials Book
Author : Janice Hedgecock
Publisher : Inst of Clinical Research
Release : 2005-07
ISBN : 0954934563
Language : En, Es, Fr & De

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Book Description :

Download Insurance in Clinical Trials book written by Janice Hedgecock, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Clinical Trials

Clinical Trials Book
Author : Tom Brody
Publisher : Academic Press
Release : 2016-02-19
ISBN : 0128042583
Language : En, Es, Fr & De

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Book Description :

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

Clinical Trials

Clinical Trials Book
Author : Steven Piantadosi
Publisher : John Wiley & Sons
Release : 2017-08-28
ISBN : 1118959205
Language : En, Es, Fr & De

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Book Description :

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. This book is accompanied by downloadable files available below under the DOWNLOADS tab. These files include: MATHEMATICA program – A set of downloadable files that tracks the chapters, containing code pertaining to each. SAS PROGRAMS and DATA FILES used in the book. The following software programs, included in the downloadables, were developed by the author, Steven Piantadosi, M.D., Ph.D: RANDOMIZATION – This program generates treatment assignments for a clinical trial using blocked stratified randomization. CRM – Implements the continual reassessment methods for dose finding clinical trials. OPTIMAL – Calculates two-stage optimal phase II designs using the Simon method. POWER – This is a power and sample size program for clinical trials. Executables for installing these programs can also be found at https://risccweb.csmc.edu/biostats/. 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.

Clinical Trial Design

Clinical Trial Design Book
Author : Sue Fitzpatrick
Publisher : Inst of Clinical Research
Release : 2006
ISBN : 1905238037
Language : En, Es, Fr & De

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Book Description :

Gives advice on how to design a clinical trial and compares the different designs.

Clinical Drug Trials and Tribulations Revised and Expanded Second Edition

Clinical Drug Trials and Tribulations  Revised and Expanded  Second Edition Book
Author : Allen Cato,Lynda Sutton,Allen Cato III
Publisher : CRC Press
Release : 2002-03-26
ISBN : 0824744802
Language : En, Es, Fr & De

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Book Description :

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... international regulation and deregulation venture capitalist investment the IND process informed consent changes in manufacturing and updated and extended coverage of... pediatric drug trial design the advantages and disadvantages of orphan drug designations the maximization of package inserts for marketing post approval safety surveillance withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

ClinicalTrials

ClinicalTrials Book
Author : Curtis L. Meinert
Publisher : OUP USA
Release : 2012-03-27
ISBN : 0195387880
Language : En, Es, Fr & De

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Book Description :

The classic, definitive guide to the design, conduct, and analysis of randomized clinical trials.

Oncology Clinical Trials

Oncology Clinical Trials Book
Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
Publisher : Demos Medical Publishing
Release : 2009-12-22
ISBN : 9781935281764
Language : En, Es, Fr & De

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Book Description :

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

Designs for Clinical Trials

Designs for Clinical Trials Book
Author : David Harrington
Publisher : Springer Science & Business Media
Release : 2011-10-09
ISBN : 9781461401407
Language : En, Es, Fr & De

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Book Description :

This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials.

The Clinical Trial Protocol

The Clinical Trial Protocol Book
Author : Sue Fitzpatrick
Publisher : Inst of Clinical Research
Release : 2005-12-01
ISBN : 1905238045
Language : En, Es, Fr & De

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Book Description :

Download The Clinical Trial Protocol book written by Sue Fitzpatrick, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Clinical Trial Metadata Defining and Extracting Metadata on the Design Conduct Results and Costs of 125 Randomised Clinical Trials Funded by the National Institute for Health Research Health Techno

Clinical Trial Metadata  Defining and Extracting Metadata on the Design  Conduct  Results and Costs of 125 Randomised Clinical Trials Funded by the National Institute for Health Research Health Techno Book
Author : Anonim
Publisher : Unknown
Release : 2015
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Clinical Trial Metadata Defining and Extracting Metadata on the Design Conduct Results and Costs of 125 Randomised Clinical Trials Funded by the National Institute for Health Research Health Techno book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics

Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics Book
Author : Jianchang Lin,Bushi Wang,Xiaowen Hu,Kun Chen,Ray Liu
Publisher : Springer
Release : 2016-11-13
ISBN : 3319425684
Language : En, Es, Fr & De

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Book Description :

The papers in this volume represent a broad, applied swath of advanced contributions to the 2015 ICSA/Graybill Applied Statistics Symposium of the International Chinese Statistical Association, held at Colorado State University in Fort Collins. The contributions cover topics that range from statistical applications in business and finance to applications in clinical trials and biomarker analysis. Each papers was peer-reviewed by at least two referees and also by an editor. The conference was attended by over 400 participants from academia, industry, and government agencies around the world, including from North America, Asia, and Europe.

Legislation and Ethics of Clinical Trials in Portugal and Spain

Legislation and Ethics of Clinical Trials in Portugal and Spain Book
Author : Anonim
Publisher : Dr Brigitte Jansen
Release : 2011
ISBN : 3869240016
Language : En, Es, Fr & De

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Book Description :

Download Legislation and Ethics of Clinical Trials in Portugal and Spain book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.