National Cancer Policy Forum – 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.

These proceedings of a workshop presented to the Institute of Medicine''s (IOM) National Cancer Policy Forum on March 30, 2007, are the result of forum discussions about genetic testing and counseling at its meetings on June 16 and October 30, 2006. Those discussions, led by forum members Betty Ferrell and Patricia Ganz, noted that genetic testing and counseling are becoming more complex and important for informing patients and families of risks and benefits of certain courses of action, and yet organized expert programs are in short supply.

The IOM''s National Cancer Policy Board estimated in 2003 that even modest efforts to implement known tactics for cancer prevention and early detection could result in up to a 29 percent drop in cancer deaths in about 20 years. The IOM''s National Cancer Policy Forum, which succeeded the Board after it was disbanded in 2005, continued the Board''s work to outline ways to increase screening in the U.S.

On February 25 and 26, 2008, the Forum convened a workshop to discuss screening for colorectal cancer. Colorectal cancer screening remains low, despite strong evidence that screening prevents deaths. With the aim to make recommended colorectal cancer screening more widespread, the workshop discussed steps to be taken at the clinic, community, and health system levels. Workshop speakers, representing a broad spectrum of leaders in the field, identified major barriers to increased screening and described strategies to overcome these obstacles. This workshop summary highlights the information presented, as well as the subsequent discussion about actions needed to increase colorectal screening and, ultimately, to prevent more colorectal cancer deaths.

The NCI-sponsored cooperative groups have made important contributions to improving treatment for many types of cancer, including breast, ovarian, colorectal, and childhood cancers. Cooperative group research has been instrumental in establishing innovative treatments that improve outcomes and quality of life. Despite these successes, the Cooperative Group Program has faced a number of challenges that threaten its effectiveness.

To address this problem, the National Cancer Policy Forum (NCPF) convened a workshop titled "Multi-Center Phase III Clinical Trials and NCI Cooperative Groups" in Washington, DC, on July 1-2, 2008. The purpose of the workshop was to outline the challenges that the public clinical cancer research enterprise faces, and to identify possible solutions to these challenges.

Unlike many other areas in health care, the practice of oncology presents unique challenges that make assessing and improving value especially complex. First, patients and professionals feel a well-justified sense of urgency to treat for cure, and if cure is not possible, to extend life and reduce the burden of disease. Second, treatments are often both life sparing and highly toxic. Third, distinctive payment structures for cancer medicines are intertwined with practice. Fourth, providers often face tremendous pressure to apply the newest technologies to patients who fail to respond to established treatments, even when the evidence supporting those technologies is incomplete or uncertain, and providers may be reluctant to stop toxic treatments and move to palliation, even at the end of life. Finally, the newest and most novel treatments in oncology are among the most costly in medicine.This volume summarizes the results of a workshop that addressed these issues from multiple perspectives, including those of patients and patient advocates, providers, insurers, health care researchers, federal agencies, and industry. Its broad goal was to describe value in oncology in a complete and nuanced way, to better inform decisions regarding developing, evaluating, prescribing, and paying for cancer therapeutics.

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.

One of the challenges in treating cancer is the disease''s complexity and variation among patients. Cancer manifests differently in each patient, so treatments that are effective in one patient may not be effective in another. As cancer care becomes more personalized, subpopulations of individuals will be given preventive or therapeutic interventions based on their susceptibility to a particular disease or their predicted response to a specific treatment. However, before the use of personalized cancer care can reach its full potential, the health care system must resolve a number of technological, regulatory, and reimbursement issues.

To explore these policy challenges, the National Cancer Policy Forum held the workshop Policy Issues in the Development of Personalized Medicine in Oncology in June 2009. Experts provided presentations on the current state of personalized medicine technology, as well as issues in the validation of, regulation of, and reimbursement for the predictive tests that underpin personalized medicine. Participants discussed the obstacles and possible solutions to further developing and using personalized medicine technologies. This document summarizes the workshop.

Unlike many other areas in health care, the practice of oncology presents unique challenges that make assessing and improving value especially complex. First, patients and professionals feel a well-justified sense of urgency to treat for cure, and if cure is not possible, to extend life and reduce the burden of disease. Second, treatments are often both life sparing and highly toxic. Third, distinctive payment structures for cancer medicines are intertwined with practice. Fourth, providers often face tremendous pressure to apply the newest technologies to patients who fail to respond to established treatments, even when the evidence supporting those technologies is incomplete or uncertain, and providers may be reluctant to stop toxic treatments and move to palliation, even at the end of life. Finally, the newest and most novel treatments in oncology are among the most costly in medicine.This volume summarizes the results of a workshop that addressed these issues from multiple perspectives, including those of patients and patient advocates, providers, insurers, health care researchers, federal agencies, and industry. Its broad goal was to describe value in oncology in a complete and nuanced way, to better inform decisions regarding developing, evaluating, prescribing, and paying for cancer therapeutics.

The IOM''s National Cancer Policy Forum held a workshop October 5-6, 2009, to examine how to apply the concept of a ''rapid learning health system'' to the problem of cancer. This document summarizes the workshop.

One of the challenges in treating cancer is the disease''s complexity and variation among patients. Cancer manifests differently in each patient, so treatments that are effective in one patient may not be effective in another. As cancer care becomes more personalized, subpopulations of individuals will be given preventive or therapeutic interventions based on their susceptibility to a particular disease or their predicted response to a specific treatment. However, before the use of personalized cancer care can reach its full potential, the health care system must resolve a number of technological, regulatory, and reimbursement issues.

To explore these policy challenges, the National Cancer Policy Forum held the workshop Policy Issues in the Development of Personalized Medicine in Oncology in June 2009. Experts provided presentations on the current state of personalized medicine technology, as well as issues in the validation of, regulation of, and reimbursement for the predictive tests that underpin personalized medicine. Participants discussed the obstacles and possible solutions to further developing and using personalized medicine technologies. This document summarizes the workshop.

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.

The IOM''s National Cancer Policy Forum held a workshop October 5-6, 2009, to examine how to apply the concept of a ''rapid learning health system'' to the problem of cancer. This document summarizes the workshop.

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.

Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they offer demonstrate a public appetite for this information and where the future of genetics may be headed; they also demonstrate the need for serious discussion about the regulatory environment, patient privacy, and other policy implications of direct-to-consumer (DTC) genetic testing. Rapid advances in genetic research already have begun to transform clinical practice and our understanding of disease progression. Existing research has revealed a genetic basis or component for numerous diseases, including Parkinson''s disease, Alzheimer''s disease, diabetes, heart disease, and several forms of cancer. The availability of the human genome sequence and the HapMap, plummeting costs of high-throughput screening, and increasingly sophisticated computational analyses have led to an explosion of discoveries of linkages between patterns of genetic variation and disease susceptibility. While this research is by no means a straight path toward better public health, improved knowledge of the genetic linkages has the potential to change fundamentally the way health professionals and public health practitioners approach the prevention and treatment of disease. Realizing this potential will require greater sophistication in the interpretation of genetic tests, new training for physicians and other diagnosticians, and new approaches to communicating findings to the public. As this rapidly growing field matures, all of these questions require attention from a variety of perspectives. To discuss some of the foregoing issues, several units of the National Academies held a workshop on August 31 and September 1, 2009, to bring together a still-developing community of professionals from a variety of relevant disciplines, to educate the public and policy-makers about this emerging field, and to identify issues for future study. The meeting featured several invited presentations and discussions on the many technical, legal, policy, and ethical questions that such DTC testing raises, including: (1) overview of the current state of knowledge and the future research trajectory; (2) shared genes and emerging issues in privacy; (3) the regulatory framework; and (4) education of the public and the medical community.

One way scientists are working to overcome challenges in cancer treatment and improve cancer care is through nanotechnology. Nanotechnology, engineered materials that make use of the unique physical properties, presents a new array of medical prospects that will revolutionize cancer prevention, diagnosis, and treatment practices. Giving new hope to patients, practitioners, and researchers alike, nanotechnology has the potential to translate recent discoveries in cancer biology into clinical advances in oncology. While public investments in nanotechnology for cancer continue to increase, medical products based on nanotechnology are already on the market.

The National Cancer Policy forum held a workshop July 12-13, 2010, to explore challenges in the use of nanotechnology in oncology. Nanotechnology and Oncology evaluates the ongoing discussion on the role of nanotechnology in cancer as it relates to risk management, treatment, and regulatory policy. Assessments on nanomedicine and the physical properties of nanomaterials were presented during the workshop, along with an appraisal of the current status of research and development efforts.

The NCI-sponsored cooperative groups have made important contributions to improving treatment for many types of cancer, including breast, ovarian, colorectal, and childhood cancers. Cooperative group research has been instrumental in establishing innovative treatments that improve outcomes and quality of life. Despite these successes, the Cooperative Group Program has faced a number of challenges that threaten its effectiveness.

To address this problem, the National Cancer Policy Forum (NCPF) convened a workshop titled "Multi-Center Phase III Clinical Trials and NCI Cooperative Groups" in Washington, DC, on July 1-2, 2008. The purpose of the workshop was to outline the challenges that the public clinical cancer research enterprise faces, and to identify possible solutions to these challenges.

The American Society of Clinical Oncology (ASCO) predicts that by 2020, there will be an 81 percent increase in people living with or surviving cancer, but only a 14 percent increase in the number of practicing oncologists. As a result, there may be too few oncologists to meet the population''s need for cancer care. To help address the challenges in overcoming this potential crisis of cancer care, the National Cancer Policy Forum of the Institute of Medicine (IOM) convened the workshop Ensuring Quality Cancer Care through the Oncology Workforce: Sustaining Care in the 21st Century in Washington, DC on October 20 and 21, 2008.

The IOM''s National Cancer Policy Board estimated in 2003 that even modest efforts to implement known tactics for cancer prevention and early detection could result in up to a 29 percent drop in cancer deaths in about 20 years. The IOM''s National Cancer Policy Forum, which succeeded the Board after it was disbanded in 2005, continued the Board''s work to outline ways to increase screening in the U.S.

On February 25 and 26, 2008, the Forum convened a workshop to discuss screening for colorectal cancer. Colorectal cancer screening remains low, despite strong evidence that screening prevents deaths. With the aim to make recommended colorectal cancer screening more widespread, the workshop discussed steps to be taken at the clinic, community, and health system levels. Workshop speakers, representing a broad spectrum of leaders in the field, identified major barriers to increased screening and described strategies to overcome these obstacles. This workshop summary highlights the information presented, as well as the subsequent discussion about actions needed to increase colorectal screening and, ultimately, to prevent more colorectal cancer deaths.

These proceedings of a workshop presented to the Institute of Medicine''s (IOM) National Cancer Policy Forum on March 30, 2007, are the result of forum discussions about genetic testing and counseling at its meetings on June 16 and October 30, 2006. Those discussions, led by forum members Betty Ferrell and Patricia Ganz, noted that genetic testing and counseling are becoming more complex and important for informing patients and families of risks and benefits of certain courses of action, and yet organized expert programs are in short supply.

A high proportion of cancer occurs primarily in older persons, and incidence of the major cancers is greater. This, combined with the expansion of an aging America, is bound to have far reaching effects on the nation''s healthcare industry.This summary of a workshop held in October 2006, reviews the various important implications of changing demographics and the cancer disease burden in the United States.

Research has long sought to identify biomarkers that could detect cancer at an early stage, or predict the optimal cancer therapy for specific patients. Fueling interest in this research are recent technological advances in genomics, proteomics, and metabolomics that can enable researchers to capture the molecular fingerprints of specific cancers and fine-tune their classification according to the molecular defects they harbor. The discovery and development of new markers of cancer could potentially improve cancer screening, diagnosis, and treatment. Given the potential impact cancer biomarkers could have on the cost effectiveness of cancer detection and treatment, they could profoundly alter the economic burden of cancer as well.Despite the promise of cancer biomarkers, few biomarker-based cancer tests have entered the market, and the translation of research findings on cancer biomarkers into clinically useful tests seems to be lagging. This is perhaps not surprising given the technical, financial, regulatory, and social challenges linked to the discovery, development, validation, and incorporation of biomarker tests into clinical practice. To explore those challenges and ways to overcome them, the National Cancer Policy Forum held the conference "Developing Biomarker-Based Tools for Cancer Screening, Diagnosis and Treatment: The State of the Science, Evaluation, Implementation, and Economics" in Washington, D.C., from March 20 to 22, 2006.At this conference, experts gave presentations in one of six sessions. In addition, seven small group discussions explored the policy implications surrounding biomarker development and adoption into clinical practice. Developing Biomarker-based Tools for Developing Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics-Workshop Summary presents the conference proceedings and will be used by an Institute of Medicine (IOM) committee to develop consensus-based recommendations for moving the field of cancer biomarkers forward.

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was enacted to improve the portability and continuity of health insurance; promote medical savings accounts; improve access to long-term care services and coverage; and simplify the administration of health insurance. HIPAA''s Administrative Simplification provisions focus on facilitating the electronic exchange of information for financial and administrative functions related to patient care. However, the very advances that make it easier to transmit information also present challenges to preserving the confidentiality of potentially sensitive personal information contained in medical records. In 2003, the President''s Cancer Panel discovered HIPAA Privacy Rule slowed research on cancer survivors, as well as causing increased bureaucracy, informed consent problems, and complications for clinical trials. Effect of the HIPAA Privacy Rule on Health Research evaluates the impact of HIPAA provisions and provides guidance to legislators on amendments needed to make this law better serve the interests of cancer survivors and others.

Today, scores of companies, primarily in the United States and Europe, are offering whole genome scanning services directly to the public. The proliferation of these companies and the services they offer demonstrate a public appetite for this information and where the future of genetics may be headed; they also demonstrate the need for serious discussion about the regulatory environment, patient privacy, and other policy implications of direct-to-consumer (DTC) genetic testing. Rapid advances in genetic research already have begun to transform clinical practice and our understanding of disease progression. Existing research has revealed a genetic basis or component for numerous diseases, including Parkinson''s disease, Alzheimer''s disease, diabetes, heart disease, and several forms of cancer. The availability of the human genome sequence and the HapMap, plummeting costs of high-throughput screening, and increasingly sophisticated computational analyses have led to an explosion of discoveries of linkages between patterns of genetic variation and disease susceptibility. While this research is by no means a straight path toward better public health, improved knowledge of the genetic linkages has the potential to change fundamentally the way health professionals and public health practitioners approach the prevention and treatment of disease. Realizing this potential will require greater sophistication in the interpretation of genetic tests, new training for physicians and other diagnosticians, and new approaches to communicating findings to the public. As this rapidly growing field matures, all of these questions require attention from a variety of perspectives. To discuss some of the foregoing issues, several units of the National Academies held a workshop on August 31 and September 1, 2009, to bring together a still-developing community of professionals from a variety of relevant disciplines, to educate the public and policy-makers about this emerging field, and to identify issues for future study. The meeting featured several invited presentations and discussions on the many technical, legal, policy, and ethical questions that such DTC testing raises, including: (1) overview of the current state of knowledge and the future research trajectory; (2) shared genes and emerging issues in privacy; (3) the regulatory framework; and (4) education of the public and the medical community.

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.

Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute''s (NCI''s) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research.

Thus, the Institute of Medicine''s (IOM''s) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation.

Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute''s (NCI''s) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research.

Thus, the Institute of Medicine''s (IOM''s) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation.