The Conduct Of A Cooperative Clinical Trial
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The Conduct Of A Cooperative Clinical Trial
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Author : K. E. Stanley
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
The Conduct Of A Cooperative Clinical Trial written by K. E. Stanley 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 2012-12-06 with Medical categories.
The purpose of this monograph is to address the basic mecha nisms for organizing trials. Is is meant to serve as a guide to individuals planning to form a cooperative group as well as to cooperative groups who wish to revise and refine their existing procedures. Current literature deals with many components of conducting clinical trials, such as trial design considerations, randomization, and methods of analysis. But there is a lack of accessible knowledge concerning data flow, data processing, and group organization which causes difficulty for many multi institutional cooperative trials. Multi-institutional cooperative studies require greater atten tion to detail than studies within a single institution. For single institution studies, a single protocol document may be suffi cient. In a cooperative group, however, it is necessary to standardize various aspects where little variation may be pre sent in a single institution study. Patients must be entered in a uniform fashion, data collection and evaluation should be standardized, and there must be a mechanism to insure the timely collection of essential data.
The Conduct Of A Cooperative Clinical Trial
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Author : K. E. Stanley
language : en
Publisher: Springer
Release Date : 2012-02-16
The Conduct Of A Cooperative Clinical Trial written by K. E. Stanley and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-16 with Medical categories.
The purpose of this monograph is to address the basic mecha nisms for organizing trials. Is is meant to serve as a guide to individuals planning to form a cooperative group as well as to cooperative groups who wish to revise and refine their existing procedures. Current literature deals with many components of conducting clinical trials, such as trial design considerations, randomization, and methods of analysis. But there is a lack of accessible knowledge concerning data flow, data processing, and group organization which causes difficulty for many multi institutional cooperative trials. Multi-institutional cooperative studies require greater atten tion to detail than studies within a single institution. For single institution studies, a single protocol document may be suffi cient. In a cooperative group, however, it is necessary to standardize various aspects where little variation may be pre sent in a single institution study. Patients must be entered in a uniform fashion, data collection and evaluation should be standardized, and there must be a mechanism to insure the timely collection of essential data.
The Conduct Of A Cooperative Clinical Trial
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Author : K. E. Stanley
language : en
Publisher: Springer
Release Date : 1981-08-01
The Conduct Of A Cooperative Clinical Trial written by K. E. Stanley and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 1981-08-01 with Medical categories.
The purpose of this monograph is to address the basic mecha nisms for organizing trials. Is is meant to serve as a guide to individuals planning to form a cooperative group as well as to cooperative groups who wish to revise and refine their existing procedures. Current literature deals with many components of conducting clinical trials, such as trial design considerations, randomization, and methods of analysis. But there is a lack of accessible knowledge concerning data flow, data processing, and group organization which causes difficulty for many multi institutional cooperative trials. Multi-institutional cooperative studies require greater atten tion to detail than studies within a single institution. For single institution studies, a single protocol document may be suffi cient. In a cooperative group, however, it is necessary to standardize various aspects where little variation may be pre sent in a single institution study. Patients must be entered in a uniform fashion, data collection and evaluation should be standardized, and there must be a mechanism to insure the timely collection of essential data.
A National Cancer Clinical Trials System For The 21st Century
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-07-08
A National Cancer Clinical Trials System For The 21st Century written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-07-08 with Medical categories.
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Clinical Trials
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Author : Timothy M. Pawlik
language : en
Publisher: Springer Nature
Release Date : 2020-03-10
Clinical Trials written by Timothy M. Pawlik and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-10 with Medical categories.
This extensively revised second edition is a unique and portable handbook focusing on clinical trials in surgery. It includes new educational materials addressing the rapid evolution of novel research methodologies in basic science, clinical and educational research. The underlying principles of clinical trials, trial design, the development of a study cohort, statistics, data safety, data monitoring, and trial publication for device and drug trials are also discussed. Clinical Trials provides a comprehensive resource on clinical trials in surgery and describes all the stages of a clinical trial from generating a hypothesis through to trial publication and is a valuable resource for all practicing and trainee academic surgeons.
Multi Center Phase Iii Clinical Trials And Nci Cooperative Groups
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2009-01-30
Multi Center Phase Iii Clinical Trials And Nci Cooperative Groups written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-01-30 with Medical categories.
The NCI-sponsored cooperative groups have made important contributions to improving treatment for many types of cancer, including breast, ovarian, colorectal, and childhood cancers. Cooperative group research has been instrumental in establishing innovative treatments that improve outcomes and quality of life. Despite these successes, the Cooperative Group Program has faced a number of challenges that threaten its effectiveness. To address this problem, the National Cancer Policy Forum (NCPF) convened a workshop titled "Multi-Center Phase III Clinical Trials and NCI Cooperative Groups" in Washington, DC, on July 1-2, 2008. The purpose of the workshop was to outline the challenges that the public clinical cancer research enterprise faces, and to identify possible solutions to these challenges.
A National Cancer Clinical Trials System For The 21st Century
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-08-08
A National Cancer Clinical Trials System For The 21st Century written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-08-08 with Medical categories.
The National Cancer Institute's (NCI) Clinical Trials Cooperative Group Program has played a key role in developing new and improved cancer therapies. However, the program is falling short of its potential, and the IOM recommends changes that aim to transform the Cooperative Group Program into a dynamic system that efficiently responds to emerging scientific knowledge; involves broad cooperation of stakeholders; and leverages evolving technologies to provide high-quality, practice-changing research.
Implementing A National Cancer Clinical Trials System For The 21st Century
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-10-19
Implementing A National Cancer Clinical Trials System For The 21st Century written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-19 with Medical categories.
Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research. Thus, the Institute of Medicine's (IOM's) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation.
Oncology Clinical Trials
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Author : William Kevin Kelly, DO
language : en
Publisher: Springer Publishing Company
Release Date : 2018-03-28
Oncology Clinical Trials written by William Kevin Kelly, DO and has been published by Springer Publishing Company this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-28 with Medical categories.
The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included
Transforming Clinical Research In The United States
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2010-10-22
Transforming Clinical Research In The United States written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10-22 with Medical categories.
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 based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.