The Drug Development Paradigm in Oncology

The Drug Development Paradigm in Oncology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-02-12

Total Pages: 145

ISBN-13: 0309457971

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Advances in cancer research have led to an improved understanding of the molecular mechanisms underpinning the development of cancer and how the immune system responds to cancer. This influx of research has led to an increasing number and variety of therapies in the drug development pipeline, including targeted therapies and associated biomarker tests that can select which patients are most likely to respond, and immunotherapies that harness the body's immune system to destroy cancer cells. Compared with standard chemotherapies, these new cancer therapies may demonstrate evidence of benefit and clearer distinctions between efficacy and toxicity at an earlier stage of development. However, there is a concern that the traditional processes for cancer drug development, evaluation, and regulatory approval could impede or delay the use of these promising cancer treatments in clinical practice. This has led to a number of effortsâ€"by patient advocates, the pharmaceutical industry, and the Food and Drug Administration (FDA)â€"to accelerate the review of promising new cancer therapies, especially for cancers that currently lack effective treatments. However, generating the necessary data to confirm safety and efficacy during expedited drug development programs can present a unique set of challenges and opportunities. To explore this new landscape in cancer drug development, the National Academies of Sciences, Engineering, and Medicine developed a workshop held in December 2016. This workshop convened cancer researchers, patient advocates, and representatives from industry, academia, and government to discuss challenges with traditional approaches to drug development, opportunities to improve the efficiency of drug development, and strategies to enhance the information available about a cancer therapy throughout its life cycle in order to improve its use in clinical practice. This publication summarizes the presentations and discussions from the workshop.


Applying Big Data to Address the Social Determinants of Health in Oncology

Applying Big Data to Address the Social Determinants of Health in Oncology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-08-14

Total Pages: 83

ISBN-13: 0309679060

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The National Academies of Sciences, Engineering, and Medicine held the workshop Applying Big Data to Address the Social Determinants of Health in Oncology on October 28â€"29, 2019, in Washington, DC. This workshop examined social determinants of health (SDOH) in the context of cancer, and considered opportunities to effectively leverage big data to improve health equity and reduce disparities. The workshop featured presentations and discussion by experts in technology, oncology, and SDOH, as well as representatives from government, industry, academia, and health care systems. This publication summarizes the presentations and discussions from the workshop.


Cancer Evolution

Cancer Evolution

Author: Charles Swanton

Publisher: Perspectives Cshl

Published: 2017

Total Pages: 350

ISBN-13: 9781621821434

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Tumor progression is driven by mutations that confer growth advantages to different subpopulations of cancer cells. As a tumor grows, these subpopulations expand, accumulate new mutations, and are subjected to selective pressures from the environment, including anticancer interventions. This process, termed clonal evolution, can lead to the emergence of therapy-resistant tumors and poses a major challenge for cancer eradication efforts. Written and edited by experts in the field, this collection from Cold Spring Harbor Perspectives in Medicine examines cancer progression as an evolutionary process and explores how this way of looking at cancer may lead to more effective strategies for managing and treating it. The contributors review efforts to characterize the subclonal architecture and dynamics of tumors, understand the roles of chromosomal instability, driver mutations, and mutation order, and determine how cancer cells respond to selective pressures imposed by anticancer agents, immune cells, and other components of the tumor microenvironment. They compare cancer evolution to organismal evolution and describe how ecological theories and mathematical models are being used to understand the complex dynamics between a tumor and its microenvironment during cancer progression. The authors also discuss improved methods to monitor tumor evolution (e.g., liquid biopsies) and the development of more effective strategies for managing and treating cancers (e.g., immunotherapies). This volume will therefore serve as a vital reference for all cancer biologists as well as anyone seeking to improve clinical outcomes for patients with cancer.


How Tobacco Smoke Causes Disease

How Tobacco Smoke Causes Disease

Author: United States. Public Health Service. Office of the Surgeon General

Publisher:

Published: 2010

Total Pages: 728

ISBN-13:

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This report considers the biological and behavioral mechanisms that may underlie the pathogenicity of tobacco smoke. Many Surgeon General's reports have considered research findings on mechanisms in assessing the biological plausibility of associations observed in epidemiologic studies. Mechanisms of disease are important because they may provide plausibility, which is one of the guideline criteria for assessing evidence on causation. This report specifically reviews the evidence on the potential mechanisms by which smoking causes diseases and considers whether a mechanism is likely to be operative in the production of human disease by tobacco smoke. This evidence is relevant to understanding how smoking causes disease, to identifying those who may be particularly susceptible, and to assessing the potential risks of tobacco products.


Establishing Effective Patient Navigation Programs in Oncology

Establishing Effective Patient Navigation Programs in Oncology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-08-13

Total Pages: 115

ISBN-13: 030947454X

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Delivering high-quality cancer care to all patients presents numerous challenges, including difficulties with care coordination and access. Patient navigation is a community-based service delivery intervention designed to promote access to timely diagnosis and treatment of cancer and other chronic diseases by eliminating barriers to care, and has often been proposed and implemented to address these challenges. However, unresolved questions include where patient navigation programs should be deployed, and which patients should be prioritized to receive navigation services when resources are limited. To address these issues and facilitate discussion on how to improve navigation services for patients with cancer, the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine held a workshop on November 13 and 14, 2017. At this workshop, a broad range of experts and stakeholders, including clinicians, navigators, researchers, and patients, explored which patients need navigation and who should serve as navigators, and the benefits of navigation and current gaps in the evidence base.


Cancer Care in Low-Resource Areas

Cancer Care in Low-Resource Areas

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-11-14

Total Pages: 127

ISBN-13: 0309458021

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Though cancer was once considered to be a problem primarily in wealthy nations, low- and middle-income countries now bear a majority share of the global cancer burden, and cancer often surpasses the burden of infectious diseases in these countries. Effective low-cost cancer control options are available for some malignancies, with the World Health Organization estimating that these interventions could facilitate the prevention of approximately one-third of cancer deaths worldwide. Effective cancer treatment approaches are also available and can reduce the morbidity and mortality due to cancer in low-resource areas. But these interventions remain inaccessible for many people in the world, especially those residing in low-resource communities that are characterized by a lack of fundsâ€"on an individual or a societal basisâ€"to cover health infrastructure and care costs. As a result, worse outcomes for patients with cancer are more common in low- and middle-income countries compared with high-income countries. Few guidelines and strategies for cancer control consider the appropriateness and feasibility of interventions in low-resource settings, and this may undermine the effectiveness of care. Recognizing the challenges of providing cancer care in resource constrained settings, the National Academies of Sciences, Engineering, and Medicine developed a two- workshop series examining cancer care in low-resource communities, building on prior work of the National Academies. The first workshop, held in October 2015, focused on cancer prevention and early detection. The second workshop was held in November 2016, and focused on cancer treatment, palliative care, and survivorship care in low-resource areas. This publication summarizes the presentations and discussions of this workshop.


Unequal Treatment

Unequal Treatment

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-02-06

Total Pages: 781

ISBN-13: 030908265X

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Racial and ethnic disparities in health care are known to reflect access to care and other issues that arise from differing socioeconomic conditions. There is, however, increasing evidence that even after such differences are accounted for, race and ethnicity remain significant predictors of the quality of health care received. In Unequal Treatment, a panel of experts documents this evidence and explores how persons of color experience the health care environment. The book examines how disparities in treatment may arise in health care systems and looks at aspects of the clinical encounter that may contribute to such disparities. Patients' and providers' attitudes, expectations, and behavior are analyzed. How to intervene? Unequal Treatment offers recommendations for improvements in medical care financing, allocation of care, availability of language translation, community-based care, and other arenas. The committee highlights the potential of cross-cultural education to improve provider-patient communication and offers a detailed look at how to integrate cross-cultural learning within the health professions. The book concludes with recommendations for data collection and research initiatives. Unequal Treatment will be vitally important to health care policymakers, administrators, providers, educators, and students as well as advocates for people of color.


Reducing Environmental Cancer Risk

Reducing Environmental Cancer Risk

Author: Suzanne H. Reuben

Publisher: DIANE Publishing

Published: 2010-10

Total Pages: 240

ISBN-13: 1437934218

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Though overall cancer incidence and mortality have continued to decline in recent years, cancer continues to devastate the lives of far too many Americans. In 2009 alone, 1.5 million American men, women, and children were diagnosed with cancer, and 562,000 died from the disease. There is a growing body of evidence linking environmental exposures to cancer. The Pres. Cancer Panel dedicated its 2008¿2009 activities to examining the impact of environmental factors on cancer risk. The Panel considered industrial, occupational, and agricultural exposures as well as exposures related to medical practice, military activities, modern lifestyles, and natural sources. This report presents the Panel¿s recommend. to mitigate or eliminate these barriers. Illus.


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

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.