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Transforming Clinical Research in the United States

Transforming Clinical Research in the United States
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 151
Release: 2010-10-22
Genre: Medical
ISBN: 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.


A National Cancer Clinical Trials System for the 21st Century

A National Cancer Clinical Trials System for the 21st Century
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 317
Release: 2010-07-08
Genre: Medical
ISBN: 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.


Cancer Clinical Trials

Cancer Clinical Trials
Author: Tomasz M. Beer
Publisher: Diamedica
Total Pages: 0
Release: 2012
Genre: Cancer
ISBN: 9780982321973

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A readable guide for anyone who is considering therapeutic options in addition to standard cancer therapy. The book seeks to share knowledge about cancer clinical trials with people living with cancer, their families and loved ones.


Clinical Trials in Oncology, Third Edition

Clinical Trials in Oncology, Third Edition
Author: Stephanie Green
Publisher: CRC Press
Total Pages: 266
Release: 2012-05-09
Genre: Mathematics
ISBN: 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.


Current Clinical Trials for Colon Cancer

Current Clinical Trials for Colon Cancer
Author:
Publisher: Curebound Publishing
Total Pages: 592
Release: 2018-04-09
Genre:
ISBN: 9780692102039

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This directory includes detailed information about 150+ currently active, interventional clinical trials for colon cancer patients. An interventional clinical trial involves cancer research using volunteer patients, also called participants, that is intended to find better treatments and/or a cure to cancer. In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the medical investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The medical investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA). Clinical trials may offer patient's new life-saving or life-extending cancer treatments. If you are a colon cancer patient, or if a friend or loved-one has been diagnosed with colon cancer, this directory might help identify a research study. The information is this exhaustive directory includes contact information for each cancer research trial, so that the patient or caretakers may obtain additional information.


Novel Designs of Early Phase Trials for Cancer Therapeutics

Novel Designs of Early Phase Trials for Cancer Therapeutics
Author: Shivaani Kummar
Publisher: Academic Press
Total Pages: 235
Release: 2018-05-22
Genre: Medical
ISBN: 0128125705

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Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. Brings a comprehensive review and recommendations for new clinical trial designs for modern cancer therapeutics Provides the reader with a better understanding on how to design and implement early phase oncology trials Presents a better and updated understanding of the process of developing new treatments for cancer, the exciting scientific advances and how they are informing drug development


A Series of Catastrophes and Miracles

A Series of Catastrophes and Miracles
Author: Mary Elizabeth Williams
Publisher: Disney Electronic Content
Total Pages: 273
Release: 2016-04-26
Genre: Biography & Autobiography
ISBN: 1426216343

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A wry, witty account of what it is like to face death—and be restored to life. After being diagnosed in her early 40s with metastatic melanoma—a "rapidly fatal" form of cancer—journalist and mother of two Mary Elizabeth Williams finds herself in a race against the clock. She takes a once-in-a-lifetime chance and joins a clinical trial for immunotherapy, a revolutionary drug regimen that trains the body to vanquish malignant cells. Astonishingly, her cancer disappears entirely in just a few weeks. But at the same time, her best friend embarks on a cancer journey of her own—with very different results. Williams's experiences as a patient and a medical test subject reveal with stark honesty what it takes to weather disease, the extraordinary new developments that are rewriting the rules of science—and the healing power of human connection.


Cancer Clinical Trials

Cancer Clinical Trials
Author: Stephen L. George
Publisher: CRC Press
Total Pages: 474
Release: 2016-08-19
Genre: Mathematics
ISBN: 1498706908

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Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials. The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.


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

Implementing a National Cancer Clinical Trials System for the 21st Century
Author: Board on Health Care Services
Publisher: National Academies Press
Total Pages: 111
Release: 2013-09-27
Genre: Medical
ISBN: 0309287278

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The National Clinical Trials Network (NCTN) supported by the National Cancer Institute (NCI) has played an integral role in cancer research and in establishing the standard of care for cancer patients for more than 50 years. Formerly known as the NCI Clinical Trials Cooperative Group Program, the NCTN is comprised of more than 2,100 institutions and 14,000 investigators, who enroll more than 20,000 cancer patients in clinical trials each year across the United States and internationally. Recognizing the recent transformative advances in cancer research that necessitate modernization in how cancer clinical trials are run, as well as inefficiencies and other challenges impeding the national cancer clinical trials program, the NCI asked the IOM to develop a set of recommendations to improve the federally funded cancer clinical trials system. These recommendations were published in the 2010 report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. In early 2011, the NCPF and the American Society of Clinical Oncology (ASCO) held a workshop in which stakeholders discussed the changes they planned to implement in response to the IOM goals and recommendations. Two years later, on February 11-12, 2013, in Washington, DC, the NCPF and ASCO reconvened stakeholders to report on the changes they have made thus far to address the IOM recommendations. At this workshop, representatives from the NCI, the NCTN, comprehensive cancer centers, patient advocacy groups, the Food and Drug Administration (FDA), industry, and other stakeholders highlighted the progress that has been made in achieving the goals for a reinvigorated national cancer clinical trials system. Implementing a National Cancer Clinical Trials System for the 21st Century is a summary of that workshop.


Landmark Trials in Oncology

Landmark Trials in Oncology
Author: Santosh Yajnik
Publisher: Springer
Total Pages: 325
Release: 2019-05-17
Genre: Medical
ISBN: 3030144054

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This book describes the evolution of treatment in oncology through the lens of approximately 250 landmark clinical trials. The well-designed clinical trial is essential to the practice of medicine. There is no field that has embraced or been transformed more by the clinical trial than oncology. Each primary cancer site has a remarkable story that can be told through clinical trials. For example, patients who presented decades ago with soft tissue sarcoma of the extremities would invariably undergo limb amputation. The landmark National Cancer Institute study by Rosenberg et al. randomized patients to limb sparing surgery followed by adjuvant radiation therapy compared with limb amputation. This study helped change the standard of care by allowing most patients to retain their functioning limbs with an improvement in quality of life and no compromise in overall survival. Such major clinical trials for common malignancies including breast, prostate, lung, gastrointestinal, genitourinary, and gynecologic cancers are discussed. Because oncology is multidisciplinary, this book should be of interest for radiation oncologists, surgeons, medical oncologists, and other physicians interested in learning more about the landmark trials that have shaped oncology.