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The National Cancer Policy Forum of the National Academies of
Sciences, Engineering, and Medicine convened a virtual workshop in
March 2021 to examine the existing evidence base on how the Patient
Protection and Affordable Care Act (ACA) has altered the landscape
of cancer prevention and care delivery in the United States. The
workshop featured presentations and discussions reviewing the
effects of the ACA on people at risk for or living with cancer and
providing insight into remaining policy challenges that could
inform future efforts to improve and support the delivery of
high-quality cancer care across the care continuum. This
publication provides a high-level summary of the discussions
presented during the workshop. Table of Contents Front Matter
Proceedings of a Workshop Appendix A: Statement of Task Appendix B:
Workshop Agenda
The National Cancer Policy Forum of the National Academies of
Sciences, Engineering, and Medicine held a public workshop,
Incorporating Weight Management and Physical Activity Throughout
the Cancer Care Continuum, on February 13 and 14, 2017, in
Washington, DC. The purpose of this workshop was to highlight the
current evidence base, gaps in knowledge, and research needs on the
associations among obesity, physical activity, weight management,
and health outcomes for cancer survivors, as well as to examine the
effectiveness of interventions for promoting physical activity and
weight management among people living with or beyond cancer.
Workshop sessions also reviewed the opportunities and challenges
for providing weight management and physical activity interventions
to cancer survivors. This publication summarizes the presentations
and discussions from the workshop. Table of Contents Front Matter
Proceedings of a Workshop Appendix A: Statement of Task Appendix B:
Workshop Agenda
The oncology careforce faces challenges as population growth in the
U.S. contributes to increases in the number of patients diagnosed
with cancer. Significant advances in cancer research, screening and
diagnostic practices, and treatment have led to the age-adjusted
declining mortality rate from cancer. However, as the field
continues to develop and advance, cancer care has become more
complex than ever before. There is a growing concern regarding the
U.S. health care system's capacity to deliver high-quality cancer
care to the increasing number of patients. The National Academies
convened a workshop on February 11-12, 2019 to explore trends in
cancer care and identify opportunities for improvement in the
rapidly developing oncology careforce. Discussions at the workshop
primarily focused on trends in demographics, the careforce, and
oncology practice, as well as implications for the future of cancer
care and strategies to improve the organization and delivery of
cancer care. Opportunities to change policy and leverage
technologies in oncology were also identified. This publication
summarizes the presentations and discussions from the workshop.
Table of Contents Front Matter Proceedings of a Workshop Appendix
A: Statement of Task Appendix B: Workshop Agenda
The public health burden from lung cancer is substantial: it is the
second most commonly diagnosed cancer and the leading cause of
cancer-related deaths in the United States. Given the individual
and population health burden of lung cancer, especially when it is
diagnosed at later stages, there has been a push to develop and
implement screening strategies for early detection. However, many
factors need to be considered for broad implementation of lung
cancer screening in clinical practice. Effective implementation
will entail understanding the balance of potential benefits and
harms of lung cancer screening, defining and reaching eligible
populations, addressing health disparities, and many more
considerations. In recognition of the substantial challenges to
developing effective lung cancer screening programs in clinical
practice, the National Academies of Sciences, Engineering, and
Medicine held a workshop in June 2016. At the workshop, experts
described the current evidence base for lung cancer screening, the
current challenges of implementation, and opportunities to overcome
them. Workshop participants also explored capacity and access
issues; best practices for screening programs; assessment of
patient outcomes, quality, and value in lung cancer screening; and
research needs that could improve implementation efforts. This
publication summarizes the presentations and discussions from the
workshop. Table of Contents Front Matter Proceedings of a Workshop
Appendix A: Statement of Task Appendix B: Workshop Agenda Appendix
C: Glossary
Immunotherapy is a form of cancer therapy that harnesses the body's
immune system to destroy cancer cells. In recent years,
immunotherapies have been developed for several cancers, including
advanced melanoma, lung cancer, and kidney cancer. In some patients
with metastatic cancers who have not responded well to other
treatments, immunotherapy treatment has resulted in complete and
durable responses. Given these promising findings, it is hoped that
continued immunotherapy research and development will produce
better cancer treatments that improve patient outcomes. With this
promise, however, there is also recognition that the clinical and
biological landscape for immunotherapies is novel and not yet well
understood. For example, adverse events with immunotherapy
treatment are quite different from those experienced with other
types of cancer therapy. Similarly, immunotherapy dosing,
therapeutic responses, and response time lines are also markedly
different from other cancer therapies. To examine these challenges
and explore strategies to overcome them, the National Academies of
Sciences, Engineering, and Medicine held a workshop in February and
March of 2016. This report summarizes the presentations and
discussions from the workshop. Table of Contents Front Matter
Proceedings of a Workshop Appendix A: Statement of Task Appendix B:
Workshop Agenda Appendix C: Glossary
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. 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 funds ? on an individual or societal
basis ? to cover health infrastructure and care costs. Few
guidelines and strategies for cancer control consider the
appropriateness and feasibility of interventions in low-resource
settings, and may undermine the effectiveness of these efforts. For
example, interventions that are designed for high-resource settings
may not account for important considerations in low-resource
settings, such as resource constraints, infrastructure
requirements, or whether a community has the capacity to deliver
downstream cancer care. Patients in resource-constrained
communities continue to face delayed diagnoses of cancer,
potentially resulting in the diagnosis of later stage cancers and
worsened patient outcomes. In addition, social stigmas,
geopolitical issues, and cultural norms may limit access to cancer
care in certain communities. Recognizing the challenges of
providing cancer care in these settings, the National Academies of
Sciences, Engineering, and Medicine developed a workshop series
examining cancer care in low-resource communities. This report
summarizes the presentations and discussions from the first
workshop, which focused on cancer prevention and early detection.
Table of Contents Front Matter Workshop Summary Appendix A:
Statement of Task Appendix B: Workshop Agenda
Despite advances in the delivery of high-quality cancer care and
improvements in patient outcomes in recent years, disparities in
cancer incidence, care, and patient outcomes persist. To examine
opportunities to improve health equity across the cancer care
continuum, the National Cancer Policy Forum and the Roundtable on
the Promotion of Health Equity hosted a public workshop, Promoting
Health Equity in Cancer Care, on October 25 and October 26, 2021.
This virtual workshop featured presentations and panel discussions
on topics that included: opportunities to improve equitable access
to affordable, high-quality cancer care; strategies to identify and
address the intersectionality of structural racism and implicit
bias in cancer care delivery; the potential for quality measurement
and payment mechanisms to incentivize health equity in cancer care
delivery; and clinical practice data collection efforts to better
assess and care for people living with and beyond cancer. This
publication summarizes the presentation and discussion of the
workshop. Table of Contents Front Matter Proceedings of a Workshop
Appendix A: Statement of Task Appendix B: Workshop Agenda
The COVID-19 pandemic has led to dramatic adjustments in cancer
care delivery and cancer research. To examine these changes, the
National Cancer Policy Forum of the National Academies of Sciences,
Engineering, and Medicine convened a virtual workshop, Innovation
in Cancer Care and Cancer Research in the Context of the COVID-19
Pandemic, in July 2021. Workshop speakers considered the lessons
learned from these adaptations in order to improve the delivery of
high-quality cancer care and the conduct of cancer clinical trials
in the post-pandemic era. This Proceedings of a Workshop highlights
presentations and discussions from the workshop. Table of Contents
Front Matter Proceedings of a Workshop Appendix A: Statement of
Task Appendix B: Workshop Agenda
Digital health encompasses a broad array of tools and strategies
with the goals of advancing research, increasing health care access
and quality, and making care more personalized. It encompasses
health content, digital health interventions, and digital
applications, such as communication tools connecting patients and
clinicians (e.g., secure email in the patient portal, text, chat,
video visit), remote monitoring tools, clinical decision support
tools, and systems for exchanging health information.
Patient-facing tools, tools for clinicians, and systems to
facilitate research and care improvement are all part of this
diverse landscape, and each raises unique opportunities and
potential challenges. To examine key policy issues for the
effective and safe development, implementation, and use of digital
health technologies in oncology research and care, the National
Cancer Policy Forum of the National Academies of Sciences,
Engineering, and Medicine held a virtual workshop in collaboration
with the Forum on Cyber Resilience. The workshop, Opportunities and
Challenges for Using Digital Health Applications in Oncology, held
on July 13-14, 2020, convened a broad group of experts, including
clinicians and researchers; patient advocates; and representatives
of federal agencies, health professional societies, health care
organizations, insurers, and the pharmaceutical and health
technology industries. Many workshop speakers found the
opportunities presented by digital health tools to be particularly
compelling for oncology; however, capitalizing on these
opportunities necessitates careful attention to the design,
implementation, and use of digital health technologies. This
publication summarizes the presentations and discussions from the
workshop. Table of Contents Front Matter Proceedings of a Workshop
Appendix A: Statement of Task Appendix B: Workshop Agenda
New technologies and improved understanding of the genesis and
progression of various cancers have added to the enthusiasm for
potential new strategies to improve screening and early detection
of cancer. Research is also under way to evaluate refinements in
current screening approaches, including determining optimal
screening intervals, the ages at which screening should begin and
end, as well as more specific estimates of the potential risks and
benefits of screening for certain populations, such as racial and
ethnic minority populations and people who have elevated risk for
specific cancers. However, there remain significant challenges to
developing, validating, and effectively implementing new cancer
screening approaches. Guidelines for screening issued by different
organizations vary considerably with no clear way of deciding which
guidelines are most trustworthy. There is also a need to improve
access to high-quality cancer screening and follow-up care,
particularly in low-resource communities and among populations who
are underserved or have numerous barriers to receiving care. To
examine the challenges and opportunities related to improving
current approaches to cancer screening, as well as the evidence
base for novel cancer screening methods, the National Cancer Policy
Forum held a workshop, Advancing Progress in the Development and
Implementation of Effective, High-Quality Cancer Screening, on
March 2-3, 2020, in Washington, DC. This workshop convened a broad
range of experts, including clinicians, researchers, statisticians,
and patient advocates, as well as representatives of health care
organizations, academic medical centers, insurers, and federal
agencies. This publication summarizes the presentations and
discussions of the workshop and highlights suggestions from
individual participants regarding how to improve cancer screening.
Table of Contents Front Matter Proceedings of a Workshop Appendix
A: Statement of Task Appendix B: Workshop Agenda
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 28?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. Table of Contents Front Matter Proceedings of a Workshop
Appendix A: Statement of Task Appendix B: Workshop Agenda
Health literacy is a critical skill for engaging in healthy
behaviors to reduce disease risk and improve health outcomes across
the continuum of cancer care. However, estimates suggest that more
than one-third of the U.S. adult population has low health
literacy, and nearly half of all patients with cancer have
difficulty understanding information about their disease or
treatment. Low health literacy among patients with cancer is
associated with poor health and treatment outcomes, including lower
adherence to treatment, higher rates of missed appointments, and an
increased risk of hospitalization. Low health literacy can also
impede informed decision making, especially as cancer care becomes
increasingly complex and as patients and their families take more
active roles in treatment decisions. To examine opportunities to
improve communication across the cancer care continuum, the
National Cancer Policy Forum collaborated with the Roundtable on
Health Literacy to host a workshop, Health Literacy and
Communication Strategies in Oncology, July 15-16, 2019, in
Washington, DC. Patients, patient advocates, clinicians, and
researchers, representatives of health care organizations, academic
medical centers, insurers, and federal agencies explored the
challenges of achieving effective communication in cancer care.
This publication summarizes the presentations and discussions of
the workshop. Table of Contents Front Matter Proceedings of a
Workshop Appendix A: Statement of Task Appendix B: Workshop Agenda
Rapid advances in cancer research, the development of new and more
sophisticated approaches to diagnostic testing, and the growth in
targeted cancer therapies are transforming the landscape of cancer
diagnosis and care. These innovations have contributed to improved
outcomes for patients with cancer, but they have also increased the
complexity involved in diagnosis and subsequent care decisions. To
examine opportunities to improve cancer diagnosis and care, the
National Academies of Sciences, Engineering, and Medicine developed
a two-workshop series. The first workshop, held on February 12?13,
2018, in Washington, DC, focused on potential strategies to ensure
that patients have access to appropriate expertise and technologies
in oncologic pathology and imaging to inform their cancer diagnosis
and treatment planning, as well as assessment of treatment response
and surveillance. This publication chronicles the presentations and
discussions at the workshop. Table of Contents Front Matter
Workshop Overview Current Diagnostic Challenges in Cancer Care
Ensuring the Quality and Accessibility of Diagnostic Expertise and
Technologies Quality Improvement Efforts Integration and
Collaboration of Specialties Wrap-Up References Appendix A:
Statement of Task Appendix B: Workshop Agenda
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 efforts?by patient advocates, the pharmaceutical
industry, and the Food and Drug Administration (FDA)?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. Table of Contents Front Matter
Proceedings of a Workshop Appendix A: Statement of Task Appendix B:
Workshop Agenda
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 funds?on an individual or a societal
basis?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. Table of Contents Front Matter
Proceedings of a Workshop Appendix A: Statement of Task Appendix B:
Workshop Agenda
In recent years, significant progress has been made in the clinical
development and use of various types of cancer immunotherapy, all
of which rely on the immune system to fight cancer. The majority of
new cancer drug applications submitted to the Food and Drug
Administration (FDA) are for immunotherapies or combinations
involving immunotherapies. One type of immunotherapy is an immune
checkpoint inhibitor. Cells in the human body have proteins that
regulate the immune system response to foreign invaders (e.g.,
cancer cells, microorganisms). However, cancer cells can coopt
these "checkpoint" proteins and thwart the immune system's ability
to recognize and attack cancer cells. To help promote an immune
response to cancer, researchers have developed immune checkpoint
inhibitors that enable T-cells to recognize cancer cells as foreign
and to prevent deactivation of an immune system response. To
examine the challenges and opportunities to develop combination
cancer therapies that include immune checkpoint inhibitors, the
National Cancer Policy Forum held a workshop on July 16?17, 2018,
in Washington, DC. This workshop convened stakeholders with a broad
range of expertise, including cancer researchers, clinicians,
patient advocates, and representatives from industry, academia, and
government. This publication summarizes the presentations and
discussions from the workshop. Table of Contents Front Matter
Proceedings of a Workshop Appendix A: Statement of Task Appendix B:
Workshop Agenda
Rising health care costs are a central fiscal challenge confronting
the United States. National spending on health care currently
accounts for 18 percent of gross domestic product (GDP), but is
anticipated to increase to 25 percent of GDP by 2037. The
Bipartisan Policy Center argues that "this rapid growth in health
expenditures creates an unsustainable burden on America's economy,
with far-reaching consequences". These consequences include
crowding out many national priorities, including investments in
education, infrastructure, and research; stagnation of employee
wages; and decreased international competitiveness.In spite of
health care costs that far exceed those of other countries, health
outcomes in the United States are not considerably better. With the
goal of ensuring that patients have access to high-quality,
affordable cancer care, the Institute of Medicine's (IOM's)
National Cancer Policy Forum convened a public workshop, Delivering
Affordable Cancer Care in the 21st Century, October 8-9, 2012, in
Washington, DC. Delivering Affordable Cancer Care in the 21st
Century summarizes the workshop. Table of Contents Front Matter
Workshop Summary Appendix: Workshop Agenda
In 2010 the Institute of Medicine (IOM) recommended a framework for
the evaluation of biomarkers in the chronic disease setting.
Published in the book Evaluation of Biomarkers and Surrogate
Endpoints in Chronic Disease, the framework is intended to bring
consistency and transparency to the previously disparate process of
biomarker evaluation. Following the book's release, the IOM
convened a 2-day discussion forum in Washington, DC, in order to
provide an opportunity for stakeholders to learn about, react to,
and discuss the book. Presentations reviewed the authoring
committee's work process, recommendations, and provided
perspectives on the book from the point of view of participants.
Thomas Fleming, professor of biostatistics and statistics at the
University of Washington, gave a keynote presentation on the
critical issues in the validation of surrogate endpoints, a
specific use of a biomarker. The present volume recounts the
discussion forum proceedings, focusing in turn on each represented
sector. A summary of Dr. Fleming's presentation then sets the
committee's recommendations within the context of biomarker
utilization. Lastly, this summary examines the main themes raised
by stakeholders, and the challenges and opportunities presented to
stakeholders by the book's recommendations. Table of Contents Front
Matter 1 Introduction 2 Committee Findings and Recommendations 3
FDA Perspectives 4 National Institutes of Health Perspectives 5
Industry Perspectives 6 Public Health, Consumer, and Consulting
Organization Perspectives 7 Presentation by Thomas Fleming:
Biomarkers and Surrogate Endpoints in Chronic Disease 8 Key Themes,
Challenges, and Opportunities 9 Importance of the Biomarker
Discussion Forum References Acronyms Glossary Appendix A:
Discussion Forum Agenda Appendix B: Summary from the Committee's
Report *Evaluation of Biomarkers and Surrogate Endpoints in Chronic
Disease*
Despite spending more time and money in developing novel
therapeutics, the success rate for new pharmacologic treatments has
been poor. Although the research and development expenditures have
grown 13 percent each year since 1970 (a 50-fold increase), the
number of new drugs approved annually is no greater now than it was
50 years ago. Over the past decade, skyrocketing costs and the
complexity of the scientific knowledge upon which to develop new
agents have provided incentives for alternative approaches to drug
development, if we are to continue to improve clinical care and
reduce mortality. These challenges create opportunities for
improved collaboration between industry, academia, government, and
philanthropic organizations at each stage in new drug development,
marketing, and implementation. Perhaps the most appropriate initial
step in addressing the need for collaboration is to consider more
precompetitive relationships that allow sharing of scientific
information to foster drug development. While these collaborative
relationships in basic and preclinical research on drug targets and
the early stages of clinical testing are acknowledged to be
potentially important drivers for innovation and more rapid
marketing of new agents, they also raise a number of concerns that
must be addressed. For example, acknowledgment of academic
productivity and independence and economic competitiveness must be
considered and these challenges managed to foster a culture of
collaboration. At the same time, regulatory issues, the need for
standardization, and intellectual property concerns must be
confronted if the current models for drug development are to be
refined to encourage robust participation in precompetitive
collaborations. Recognizing the growing importance of
precompetitive collaborations in oncology drug development, as well
as the challenges these innovative collaborations pose, the
National Cancer Policy Forum of the Institute of Medicine held a
workshop on February 9 and 10, 2010. This book is a summary of the
workshop proceedings. Table of Contents Front Matter Workshop
Summary Acronyms Glossary Appendix A: Workshop Agenda Appendix B:
Polling Results
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