Erin Balogh – författare

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.

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.

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.

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.

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.

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.

Many ongoing changes are likely to have an impact on cancer research and care. For example, technological advances are rapidly changing the way cancer research is conducted, and the recently passed healthcare reform legislation has many implications for cancer care. Technological advances are altering the way cancer research is conducted and cancer care is delivered, and the recently passed healthcare reform legislation has many implications for cancer care. There is a growing emphasis on molecularly targeted therapies, information technology (IT), and patient-centered care, and clinical cancer research has become a global endeavor. At the same time, there are concerns about shrinking research budgets and escalating costs of cancer care.

Considering such changes, the National Cancer Policy Forum (NCPF) of the Institute of Medicine held a National Cancer Policy Summit on October 25, 2010. The Summit convened key leaders in the cancer community to identify and discuss the most pressing policy issues in cancer research and cancer care. The National Cancer Policy Summit: Opportunities and Challenges in Cancer Research and Care is a summary of the summit. The report explores policy issues related to cancer research, the implementation of healthcare reform, delivery of cancer care, and cancer control and public health needs. Expert participants suggested many potential actions to provide patient-centered cancer care, to foster more collaboration, and to achieve other goals to improve research and care.

Each year approximately 1.5 million people are diagnosed with cancer in the United States, most of whom inevitably face difficult decisions concerning their course of care. Recognizing challenges associated with cancer treatment, the National Coalition for Cancer Survivorship (NCCS) and the National Cancer Policy Forum (NCPF) of the Institute of Medicine (IOM) hosted a public workshop in Washington, DC on February 28 and March 1, 2011, entitled Patient-Centered Cancer Treatment Planning: Improving the Quality of Oncology Care.

This workshop summary includes an overview of patient-centered care and cancer treatment planning, as well as subject areas on shared decision making, communication in the cancer care setting, and patient experiences with cancer treatment. Best practices, models of treatment planning, and tools to facilitate their use are also discussed, along with policy changes that may promote patient-centeredness by enhancing patient''s understanding of and commitment to the goals of treatment through shared decision-making process with their healthcare team from the moment of diagnosis onward. Moreover, Patient-Centered Cancer Treatment Planning emphasizes treatment planning for patients with cancer at the time diagnosis.

Each year approximately 1.5 million people are diagnosed with cancer in the United States, most of whom inevitably face difficult decisions concerning their course of care. Recognizing challenges associated with cancer treatment, the National Coalition for Cancer Survivorship (NCCS) and the National Cancer Policy Forum (NCPF) of the Institute of Medicine (IOM) hosted a public workshop in Washington, DC on February 28 and March 1, 2011, entitled Patient-Centered Cancer Treatment Planning: Improving the Quality of Oncology Care.

This workshop summary includes an overview of patient-centered care and cancer treatment planning, as well as subject areas on shared decision making, communication in the cancer care setting, and patient experiences with cancer treatment. Best practices, models of treatment planning, and tools to facilitate their use are also discussed, along with policy changes that may promote patient-centeredness by enhancing patient''s understanding of and commitment to the goals of treatment through shared decision-making process with their healthcare team from the moment of diagnosis onward. Moreover, Patient-Centered Cancer Treatment Planning emphasizes treatment planning for patients with cancer at the time diagnosis.

Many ongoing changes are likely to have an impact on cancer research and care. For example, technological advances are rapidly changing the way cancer research is conducted, and the recently passed healthcare reform legislation has many implications for cancer care. Technological advances are altering the way cancer research is conducted and cancer care is delivered, and the recently passed healthcare reform legislation has many implications for cancer care. There is a growing emphasis on molecularly targeted therapies, information technology (IT), and patient-centered care, and clinical cancer research has become a global endeavor. At the same time, there are concerns about shrinking research budgets and escalating costs of cancer care.

Considering such changes, the National Cancer Policy Forum (NCPF) of the Institute of Medicine held a National Cancer Policy Summit on October 25, 2010. The Summit convened key leaders in the cancer community to identify and discuss the most pressing policy issues in cancer research and cancer care. The National Cancer Policy Summit: Opportunities and Challenges in Cancer Research and Care is a summary of the summit. The report explores policy issues related to cancer research, the implementation of healthcare reform, delivery of cancer care, and cancer control and public health needs. Expert participants suggested many potential actions to provide patient-centered cancer care, to foster more collaboration, and to achieve other goals to improve research and care.

Advances in biomedical research have increased our understanding of the complex nature of disease and the interaction of multiple molecular pathways involved in cancer. Combining investigational products early in their development is thought to be a promising strategy for identifying effective therapies. The IOM''s National Cancer Policy Forum held a workshop to discuss challenges and identify potential solutions to improve collaboration and advance the development of combination investigational cancer therapies.

Tobacco use is the leading cause of preventable death in United States, causing more than 440,000 deaths annually and resulting in $193 billion in health-related economic losses each year—$96 billion in direct medical costs and $97 billion in lost productivity. Since the first U.S. Surgeon General''s report on smoking in 1964, more than 29 Surgeon General''s reports, drawing on data from thousands of studies, have documented the overwhelming and conclusive biologic, epidemiologic, behavioral, and pharmacologic evidence that tobacco use is deadly. This evidence base links tobacco use to the development of multiple types of cancer and other life-threatening conditions, including cardiovascular and respiratory diseases. Smoking accounts for at least 30 percent of all cancer deaths, and 80 percent of lung cancer deaths. Despite the widespread agreement on the dangers of tobacco use and considerable success in reducing tobacco use prevalence from over 40 percent at the time of the 1964 Surgeon General''s report to less than 20 percent today, recent progress in reducing tobacco use has slowed. An estimated 18.9 percent of U.S. adults smoke cigarettes, nearly one in four high school seniors smoke, and 13 percent of high school males use smokeless tobacco products.

In recognition that progress in combating cancer will not be fully achieved without addressing the tobacco problem, the National Cancer Policy Forum of the Institute of Medicine (IOM) convened a public workshop, Reducing Tobacco-Related Cancer Incidence and Mortality, June 11-12, 2012 in Washington, DC. In opening remarks to the workshop participants, planning committee chair Roy Herbst, professor of medicine and of pharmacology and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital, described the goals of the workshop, which were to examine the current obstacles to tobacco control and to discuss potential policy, outreach, and treatment strategies that could overcome these obstacles and reduce tobacco-related cancer incidence and mortality. Experts explored a number of topics, including: the changing demographics of tobacco users and the changing patterns of tobacco product use; the influence of tobacco use on cancer incidence and cancer treatment outcomes; tobacco dependence and cessation programs; federal and state level laws and regulations to curtail tobacco use; tobacco control education, messaging, and advocacy; financial and legal challenges to tobacco control efforts; and research and infrastructure needs to support tobacco control strategies, reduce tobacco related cancer incidence, and improve cancer patient outcomes. Reducing Tobacco-Related Cancer Incidence and Mortality summarizes the workshop.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.