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

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

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 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 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 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

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

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

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

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*