Clinical Trials

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Clinical Trials


Clinical Trials
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Fundamentals Of Clinical Trials


Fundamentals Of Clinical Trials
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Author : Lawrence M. Friedman
language : en
Publisher: Springer Science & Business Media
Release Date : 1998

Fundamentals Of Clinical Trials written by Lawrence M. Friedman and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Medical categories.


The randomized control clinical trial has become the gold standard scientific method for the evaluation of pharmaceuticals, biologics, devices, procedures and diagnostic tests. This trial design has been successfully used in both therapeutic and disease prevention trials. It is superior to alternative designs by eliminating several sources of bias which exist in those designs. This role has evolved over the past three decades in a number of disease areas including cardiology, opthalmology, cancer and AIDS. While the specifics of using the randomized control design for a specific intervention and disease may differ, the basic fundamentals still apply in developing the study protocol and operational procedures. These fundamentals still apply in developing the study protocol and operational procedures. These fundamentals include identifying the specific questions to be tested and appropriate outcome measures, determining an adequate sample size, specifying the randomization procedure, detailing the intervention with visit schedules for subject evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan and determining the organizational structure.This text is structured to address the fundamentals as the protocol for a clinical trial is being developed. A chapter is devoted to each of the critical areas of a protocol to aid the clinical trial researcher. The fundamentals described in this text are based on sound scientific methodology, statistical principles and years of accumulated experience by the three authors. Collectively, the authors have been active researchers in a broad area of clinical trials including cardiology, cancer, opthalmology, diabetes, osteoporosis, AIDS, women's health and screening tests. In these studies, the authors have served as members of the steering committee responsible for developing the protocol and as members of data and safety monitoring committees. The fundamentals were proposed in the first edition published in 1981 and have not changed substantially in the later editions. However, the number of examples illustrating the fundamentals has greatly expanded base on the collective experience of the authors.This text 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 test uses numerous examples of published clinical trials from a variety of medical disciples to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity.The text assumes that the readers have only a modest formal statistical background. A basic introductory statistics course is helpful in maximizing the benefit of the text. However, a researcher or practitioner with no statistical background would still find most, if not all the chapters understandable and useful.

Clinical Trials


Clinical Trials
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Author : Steven Piantadosi
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-29

Clinical Trials written by Steven Piantadosi and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-29 with Mathematics categories.


Learn rigorous statistical methods to ensure valid clinicaltrials This Second Edition of the critically hailed Clinical Trials buildson the text's reputation as a straightforward and authoritativepresentation of statistical methods for clinical trials. Readersare introduced to the fundamentals of design for various types ofclinical trials and then skillfully guided through the completeprocess of planning the experiment, assembling a study cohort,assessing data, and reporting results. Throughout the process, theauthor alerts readers to problems that may arise during the courseof the trial and provides commonsense solutions. The author bases the revisions and updates on his own classroomexperience, as well as feedback from students, instructors, andmedical and statistical professionals involved in clinical trials.The Second Edition greatly expands its coverage, ranging fromstatistical principles to controversial topics, includingalternative medicine and ethics. At the same time, it offers morepragmatic advice for issues such as selecting outcomes, samplesize, analysis, reporting, and handling allegations of misconduct.Readers familiar with the First Edition will discover completelynew chapters, including: * Contexts for clinical trials * Statistical perspectives * Translational clinical trials * Dose-finding and dose-ranging designs Each chapter is accompanied by a summary to reinforce the keypoints. Revised discussion questions stimulate critical thinkingand help readers understand how they can apply their newfoundknowledge, and updated references are provided to direct readers tothe most recent literature. This text distinguishes itself with its accessible and broadcoverage of statistical design methods--the crucial building blocksof clinical trials and medical research. Readers learn to conductclinical trials that produce valid qualitative results backed byrigorous statistical methods.

Clinical Trials


Clinical Trials
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Author : Tom Brody
language : en
Publisher: Academic Press
Release Date : 2016-02-19

Clinical Trials written by Tom Brody and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-02-19 with Medical categories.


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 In Oncology Third Edition


Clinical Trials In Oncology Third Edition
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Author : Stephanie Green
language : en
Publisher: CRC Press
Release Date : 2012-05-09

Clinical Trials In Oncology Third Edition written by Stephanie Green and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-09 with Mathematics categories.


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
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Author : Stuart J. Pocock
language : en
Publisher: John Wiley & Sons
Release Date : 2013-07-17

Clinical Trials written by Stuart J. Pocock and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-07-17 with Medical categories.


This comprehensive, unified text on the principles and practice of clinical trials presents a detailed account of how to conduct the trials. It describes the design, analysis, and interpretation of clinical trials in a non-technical manner and provides a general perspective on their historical development, current status, and future strategy. Features examples derived from the author's personal experience.

Data Monitoring In Clinical Trials


Data Monitoring In Clinical Trials
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Author : David L. DeMets
language : en
Publisher: Springer Science & Business Media
Release Date : 2006-06-22

Data Monitoring In Clinical Trials written by David L. DeMets and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-06-22 with Medical categories.


From the authors of "Fundamentals of Clinical Trials" which has sold over 15,000 copies world wide since its publication in 1998. No competition yet as the text does not focus on how to do clinical trials but on very specific situations that can be encountered during the process.

Business Administration For Clinical Trials Managing Research Strategy Finance Regulation And Quality


Business Administration For Clinical Trials Managing Research Strategy Finance Regulation And Quality
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Author : R. Jennifer Cavalieri
language : en
Publisher: Sigma Theta Tau
Release Date : 2014-11-19

Business Administration For Clinical Trials Managing Research Strategy Finance Regulation And Quality written by R. Jennifer Cavalieri and has been published by Sigma Theta Tau this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-11-19 with Medical categories.


This guidebook provides research professionals with a deeper understanding of strategic planning, financial management, and regulatory implementation. This book demonstrates a strategy for managing your portfolio of clinical trials, provides tactics and real-world examples, and helps the reader adapt them to their own research site.