Fundamentals of Clinical Trials

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Read or download book entitled Fundamentals of Clinical Trials written by Lawrence M. Friedman and published by Springer Science & Business Media in PDF, EPUB and Kindle Format. Click Get This Book button to download or read online books. Join over 650.000 happy Readers and READ as many books as you like. We cannot guarantee that Fundamentals of Clinical Trials book is available in the library.

  • Publisher : Springer Science & Business Media
  • Release : 04 February 1998
  • ISBN : 0387985867
  • Page : 384 pages
  • Rating : 4.5/5 from 2 voters

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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.

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Fundamentals of Clinical Trials

Fundamentals of Clinical Trials
  • Author : Lawrence M. Friedman,Curt Furberg,David L. DeMets
  • Publisher : Springer Science & Business Media
  • Release Date : 1998
  • ISBN : 0387985867
GET THIS BOOKFundamentals of Clinical Trials

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

Clinical Trials

Clinical Trials
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release Date : 2016-02-19
  • ISBN : 9780128042588
GET THIS BOOKClinical Trials

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

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials
  • Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
  • Publisher : National Academies Press
  • Release Date : 2011-01-21
  • ISBN : 9780309158145
GET THIS BOOKThe Prevention and Treatment of Missing Data in Clinical Trials

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or

Clinical Trials

Clinical Trials
  • Author : Stuart J. Pocock
  • Publisher : John Wiley & Sons
  • Release Date : 2013-07-17
  • ISBN : 9781118794104
GET THIS BOOKClinical Trials

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.

Handbook of Neuroemergency Clinical Trials

Handbook of Neuroemergency Clinical Trials
  • Author : Brett E. Skolnick,Wayne M. Alves
  • Publisher : Academic Press
  • Release Date : 2017-11-13
  • ISBN : 9780128041017
GET THIS BOOKHandbook of Neuroemergency Clinical Trials

Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher : National Academies Press
  • Release Date : 2010-10-22
  • ISBN : 0309163358
GET THIS BOOKTransforming Clinical Research in the United States

An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is

Small Clinical Trials

Small Clinical Trials
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
  • Publisher : National Academies Press
  • Release Date : 2001-01-01
  • ISBN : 0309171148
GET THIS BOOKSmall Clinical Trials

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of

Virtual Clinical Trials

Virtual Clinical Trials
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
  • Publisher : National Academies Press
  • Release Date : 2019-11-16
  • ISBN : 9780309494885
GET THIS BOOKVirtual Clinical Trials

Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies

Principles and Practice of Clinical Trial Medicine

Principles and Practice of Clinical Trial Medicine
  • Author : Richard Chin,Bruce Y Lee
  • Publisher : Elsevier
  • Release Date : 2008-07-25
  • ISBN : 0080557937
GET THIS BOOKPrinciples and Practice of Clinical Trial Medicine

Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting

A Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials
  • Author : JoAnn Pfeiffer,Cris Wells
  • Publisher : CRC Press
  • Release Date : 2017-05-18
  • ISBN : 9781315299778
GET THIS BOOKA Practical Guide to Managing Clinical Trials

A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes,

Bayesian Approaches to Clinical Trials and Health-Care Evaluation

Bayesian Approaches to Clinical Trials and Health-Care Evaluation
  • Author : David J. Spiegelhalter,Keith R. Abrams,Jonathan P. Myles
  • Publisher : John Wiley & Sons
  • Release Date : 2004-01-16
  • ISBN : 0471499757
GET THIS BOOKBayesian Approaches to Clinical Trials and Health-Care Evaluation

READ ALL ABOUT IT! David Spiegelhalter has recently joined the ranks of Isaac Newton, Charles Darwin and Stephen Hawking by becoming a fellow of the Royal Society. Originating from the Medical Research Council’s biostatistics unit, David has played a leading role in the Bristol heart surgery and Harold Shipman inquiries. Order a copy of this author’s comprehensive text TODAY! The Bayesian approach involves synthesising data and judgement in order to reach conclusions about unknown quantities and make predictions.

Behavioral Clinical Trials for Chronic Diseases

Behavioral Clinical Trials for Chronic Diseases
  • Author : Lynda H. Powell,Kenneth E. Freedland,Peter G. Kaufmann
  • Publisher : Springer Nature
  • Release Date : 2021
  • ISBN : 9783030393304
GET THIS BOOKBehavioral Clinical Trials for Chronic Diseases

This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to speak the language of medicine through the conduct of high-quality behavioral clinical trials that match the

Global Clinical Trials

Global Clinical Trials
  • Author : Richard Chin,Menghis Bairu
  • Publisher : Academic Press
  • Release Date : 2011-05-06
  • ISBN : 012381538X
GET THIS BOOKGlobal Clinical Trials

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in

Integrating Clinical Research into Epidemic Response

Integrating Clinical Research into Epidemic Response
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Global Health,Committee on Clinical Trials During the 2014-2015 Ebola Outbreak
  • Publisher : National Academies Press
  • Release Date : 2017-07-26
  • ISBN : 9780309457767
GET THIS BOOKIntegrating Clinical Research into Epidemic Response

The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage

Neuroscience Trials of the Future

Neuroscience Trials of the Future
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
  • Publisher : National Academies Press
  • Release Date : 2016-12-07
  • ISBN : 9780309442558
GET THIS BOOKNeuroscience Trials of the Future

On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now,