A National Cancer Clinical Trials System for the 21st Century

A National Cancer Clinical Trials System for the 21st Century PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-07-08

Total Pages: 317

ISBN-13: 0309157870

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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

Implementing a National Cancer Clinical Trials System for the 21st Century PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-09-19

Total Pages: 122

ISBN-13: 0309212715

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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.

Clinical Trials in Oncology, Third Edition

Clinical Trials in Oncology, Third Edition PDF

Author: Stephanie Green

Publisher: CRC Press

Published: 2012-05-09

Total Pages: 266

ISBN-13: 1439814481

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The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.

A National Cancer Clinical Trials System for the 21st Century

A National Cancer Clinical Trials System for the 21st Century PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-08-08

Total Pages: 316

ISBN-13: 0309151864

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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.

Transforming Clinical Research in the United States

Transforming Clinical Research in the United States PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-10-22

Total Pages: 151

ISBN-13: 0309163358

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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.

Ensuring Quality Cancer Care

Ensuring Quality Cancer Care PDF

Author: National Cancer Policy Board

Publisher: National Academies Press

Published: 1999-08-04

Total Pages: 257

ISBN-13: 0309518792

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We all want to believe that when people get cancer, they will receive medical care of the highest quality. Even as new scientific breakthroughs are announced, though, many cancer patients may be getting the wrong care, too little care, or too much care, in the form of unnecessary procedures. How close is American medicine to the ideal of quality cancer care for every person with cancer? Ensuring Quality Cancer Care provides a comprehensive picture of how cancer care is delivered in our nation, from early detection to end-of-life issues. The National Cancer Policy Board defines quality care and recommends how to monitor, measure, and extend quality care to all people with cancer. Approaches to accountability in health care are reviewed. What keeps people from getting care? The book explains how lack of medical coverage, social and economic status, patient beliefs, physician decision-making, and other factors can stand between the patient and the best possible care. The board explores how cancer care is shaped by the current focus on evidence-based medicine, the widespread adoption of managed care, where services are provided, and who provides care. Specific shortfalls in the care of breast and prostate cancer are identified. A status report on health services research is included. Ensuring Quality Cancer Care offers wide-ranging data and information in clear context. As the baby boomers approach the years when most cancer occurs, this timely volume will be of special interest to health policy makers, public and private healthcare purchasers, medical professionals, patient advocates, researchers, and people with cancer.