Sharyl J. Nass – författare

X-ray mammography screening is the current mainstay for early breast cancer detection. It has been proven to detect breast cancer at an earlier stage and to reduce the number of women dying from the disease. However, it has a number of limitations. These current limitations in early breast cancer detection technology are driving a surge of new technological developments, from modifications of x-ray mammography such as computer programs that can indicate suspicious areas, to newer methods of detection such as magnetic resonance imaging (MRI) or biochemical tests on breast fluids. To explore the merits and drawbacks of these new breast cancer detection techniques, the Institute of Medicine of the National Academy of Sciences convened a committee of experts. During its year of operation, the committee examined the peer-reviewed literature, consulted with other experts in the field, and held two public workshops. In addition to identifying promising new technologies for early detection, the committee explored potential barriers that might prevent the development of new detection methods and their common usage.Such barriers could include lack of funding from agencies that support research and lack of investment in the commercial sector; complicated, inconsistent, or unpredictable federal regulations; inadequate insurance reimbursement; and limited access to or unacceptability of breast cancer detection technology for women and their doctors. Based on the findings of their study, the committee prepared a report entitled Mammography and Beyond: Developing Technology for Early Detection of Breast Cancer, which was published in the spring of 2001. This is a non-technical summary of that report.

The nature of biomedical research has been evolving in recent years. Technological advances that make it easier to study the vast complexity of biological systems have led to the initiation of projects with a larger scale and scope. In many cases, these large-scale analyses may be the most efficient and effective way to extract functional information from complex biological systems. Large-Scale Biomedical Science: Exploring Strategies for Research looks at the role of these new large-scale projects in the biomedical sciences. Though written by the National Academiesa (TM) Cancer Policy Board, this book addresses implications of large-scale science extending far beyond cancer research. It also identifies obstacles to the implementation of these projects, and makes recommendations to improve the process. The ultimate goal of biomedical research is to advance knowledge and provide useful innovations to society. Determining the best and most efficient method for accomplishing that goal, however, is a continuing and evolving challenge.The recommendations presented in Large-Scale Biomedical Science are intended to facilitate a more open, inclusive, and accountable approach to large-scale biomedical research, which in turn will maximize progress in understanding and controlling human disease.

More than a quarter of pregnancies worldwide are unintended. Between 1995 and 2000, nearly 700,000 women died and many more experienced illness, injury, and disability as a result of unintended pregnancy. Children born from unplanned conception are at greater risk of low birth weight, of being abused, and of not receiving sufficient resources for healthy development. A wider range of contraceptive options is needed to address the changing needs of the populations of the world across the reproductive life cycle, but this unmet need has not been a major priority of the research community and pharmaceutical industry. New Frontiers in Contraceptive Research: A Blueprint for Action, a new report from the Institute of Medicine of the National Academies, identifies priority areas for research to develop new contraceptives. The report highlights new technologies and approaches to biomedical research, including genomics and proteomics, which hold particular promise for developing new products. It also identifies impediments to drug development that must be addressed.Research sponsors, both public and private, will find topics of interest among the recommendations, which are diverse but interconnected and important for improving the range of contraceptive products, their efficacy, and their acceptability.

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.

Many cancer patients are diagnosed at a stage in which the cancer is too far advanced to be cured, and most cancer treatments are effective in only a minority of patients undergoing therapy. Thus, there is tremendous opportunity to improve the outcome for people with cancer by enhancing detection and treatment approaches. Biomarkers will be instrumental in making that transition. Advances in biotechnology and genomics have given scientists new hope that biomarkers can be used to improve cancer screening and detection, to improve the drug development process, and to enhance the effectiveness and safety of cancer care by allowing physicians to tailor treatment for individual patients—an approach known as personalized medicine. However, progress overall has been slow, despite considerable effort and investment, and there are still many challenges and obstacles to overcome before this paradigm shift in oncology can become a reality.

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

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.

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.

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 more than 180,000 new cases of breast cancer are diagnosed in women in the U.S. If cancer is detected when small and local, treatment options are less dangerous, intrusive, and costly-and more likely to lead to a cure. Yet those simple facts belie the complexity of developing and disseminating acceptable techniques for breast cancer diagnosis. Even the most exciting new technologies remain clouded with uncertainty. Mammography and Beyond provides a comprehensive and up-to-date perspective on the state of breast cancer screening and diagnosis and recommends steps for developing the most reliable breast cancer detection methods possible. This book reviews the dramatic expansion of breast cancer awareness and screening, examining the capabilities and limitations of current and emerging technologies for breast cancer detection and their effectiveness at actually reducing deaths.The committee discusses issues including national policy toward breast cancer detection, roles of public and private agencies, problems in determining the success of a technique, availability of detection methods to specific populations of women, women's experience during the detection process, cost-benefit analyses, and more. Examining current practices and specifying research and other needs, Mammography and Beyond will be an indispensable resource to policy makers, public health officials, medical practitioners, researchers, women's health advocates, and concerned women and their families.

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.

Recent research suggests that obesity and excess weight can play a prominent role in the incidence and progression of various cancers. Obesity results from an energy imbalance - that is, energy intake that is higher than energy expenditure - could also influence the growth of cancers. Recognizing the impact that current findings on obesity and cancer could have on future cancer prevention and care, the National Cancer policy Forum (NCPF) of the Institute of Medicine (IOM) help a 2-day workshop on "The Role of Obesity in Cancer Survival and Recurrence," in Washington, DC, on October 31 and November 1, 2011. The Role of Obesity in Cancer Survival and Recurrence: Workshop Summary reviews each presenter's latest clinical evidence on the obesity-cancer link and the molecular mechanisms that might explain that link. Clinicians, researchers, cancer survivors, and policy makers also discussed potential interventions to counter the effects of obesity on cancer, and research and policy measures needed to stem the rising tide of cancer mortality predicted by an increasingly overweight and older population worldwide.The Role of Obesity in Cancer Survival and Recurrence: Workshop Summary explores the complex web of molecular mechanisms that underlie the obesity-cancer link, the ways to design future studies to acquire the information needed to guide patient care, what to advise cancer patients about weight loss, diet, exercise, and other measures to reduce their risk of cancer progression or recurrence and policy suggestions related to research, education, and dissemination of the findings on obesity and cancer.

As information technology becomes an integral part of health care, it is important to collect and analyze data in a way that makes the information understandable and useful. Informatics tools--which help collect, organize, and analyze data--are essential to biomedical and health research and development. The field of cancer research is facing an overwhelming deluge of data, heightening the national urgency to find solutions to support and sustain the cancer informatics ecosystem. There is a particular need to integrate research and clinical data to facilitate personalized medicine approaches to cancer prevention and treatment--for example, tailoring treatment based on an individual patient's genetic makeup as well as that of the tumor --and to allow for more rapid learning from patient experiences. To further examine informatics needs and challenges for 21st century biomedical research, the IOM's National Cancer Policy Forum held a workshop February 27-28, 2012.The workshop was designed to raise awareness of the critical and urgent importance of the challenges, gaps and opportunities in informatics; to frame the issues surrounding the development of an integrated system of cancer informatics for acceleration of research; and to discuss solutions for transformation of the cancer informatics enterprise. Informatics Needs and Challenges in Cancer Research: Workshop Summary summarizes the workshop.

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 persistent trends in suicide necessitate action among mental health care providers and payers, researchers, and community leaders. Health care settings provide an important opportunity for suicide intervention and prevention, but they cannot yet fully manage suicide risk because of a lack of training, knowledge gaps, and reimbursement challenges. School, workplace, and community-based interventions can help reduce the incidence of suicidal behavior, as can better access to care and reduced access to lethal means of suicide.To better understand the strategies to improve access to effective interventions to prevent suicide, the Forum on Mental Health and Substance Use Disorders at the National Academies of Sciences, Engineering, and Medicine hosted a two-part virtual public workshop, Strategies and Interventions to Reduce Suicide, on June 22, 2021, and July 28, 2021. The first webinar examined the scope of the public health problem, discussed implementation of effective approaches for suicide prevention care, and addressed known barriers to health care access. The second webinar focused on building 9-8-8, the new nationwide emergency number designated to the National Suicide Prevention Lifeline. Participants discussed current crisis systems, gaps, challenges, and needs for marginalized populations. This Proceedings of a Workshop summarizes the presentations and discussions that occurred during the workshops.

In the United States, approximately 14 million people have had cancer and more than 1.6 million new cases are diagnosed each year. However, more than a decade after the Institute of Medicine (IOM) first studied the quality of cancer care, the barriers to achieving excellent care for all cancer patients remain daunting. Care often is not patient-centered, many patients do not receive palliative care to manage their symptoms and side effects from treatment, and decisions about care often are not based on the latest scientific evidence. The cost of cancer care also is rising faster than many sectors of medicine--having increased to $125 billion in 2010 from $72 billion in 2004--and is projected to reach $173 billion by 2020. Rising costs are making cancer care less affordable for patients and their families and are creating disparities in patients' access to high-quality cancer care. There also are growing shortages of health professionals skilled in providing cancer care, and the number of adults age 65 and older--the group most susceptible to cancer--is expected to double by 2030, contributing to a 45 percent increase in the number of people developing cancer.The current care delivery system is poorly prepared to address the care needs of this population, which are complex due to altered physiology, functional and cognitive impairment, multiple coexisting diseases, increased side effects from treatment, and greater need for social support. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis presents a conceptual framework for improving the quality of cancer care. This study proposes improvements to six interconnected components of care: (1) engaged patients; (2) an adequately staffed, trained, and coordinated workforce; (3) evidence-based care; (4) learning health care information technology (IT); (5) translation of evidence into clinical practice, quality measurement and performance improvement; and (6) accessible and affordable care. This report recommends changes across the board in these areas to improve the quality of care.Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis provides information for cancer care teams, patients and their families, researchers, quality metrics developers, and payers, as well as HHS, other federal agencies, and industry to reevaluate their current roles and responsibilities in cancer care and work together to develop a higher quality care delivery system. By working toward this shared goal, the cancer care community can improve the quality of life and outcomes for people facing a cancer diagnosis.

The National Clinical Trials Network (NCTN) supported by the National Cancer Institute (NCI) has played an integral role in cancer research and in establishing the standard of care for cancer patients for more than 50 years. Formerly known as the NCI Clinical Trials Cooperative Group Program, the NCTN is comprised of more than 2,100 institutions and 14,000 investigators, who enroll more than 20,000 cancer patients in clinical trials each year across the United States and internationally. Recognizing the recent transformative advances in cancer research that necessitate modernization in how cancer clinical trials are run, as well as inefficiencies and other challenges impeding the national cancer clinical trials program, the NCI asked the IOM to develop a set of recommendations to improve the federally funded cancer clinical trials system. These recommendations were published in the 2010 report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program.In early 2011, the NCPF and the American Society of Clinical Oncology (ASCO) held a workshop in which stakeholders discussed the changes they planned to implement in response to the IOM goals and recommendations. Two years later, on February 11-12, 2013, in Washington, DC, the NCPF and ASCO reconvened stakeholders to report on the changes they have made thus far to address the IOM recommendations. At this workshop, representatives from the NCI, the NCTN, comprehensive cancer centers, patient advocacy groups, the Food and Drug Administration (FDA), industry, and other stakeholders highlighted the progress that has been made in achieving the goals for a reinvigorated national cancer clinical trials system. Implementing a National Cancer Clinical Trials System for the 21st Century is a summary of that workshop.

Identifying and Addressing the Needs of Adolescents and Young Adults with Cancer is the summary of a workshop convened by the Institute of Medicine's National Cancer Policy Forum in July 2013 to facilitate discussion about gaps and challenges in caring for adolescent and young adult cancer patients and potential strategies and actions to improve the quality of their care. The workshop featured invited presentations from clinicians and other advocates working to improve the care and outcomes for the adolescent and young adult population with cancer. Cancer is the leading disease-related cause of death in adolescents and young adults. Each year nearly 70,000 people between the ages of 15 and 39 are diagnosed with cancer, approximately 8 times more than children under age 15. This population faces a variety of unique short- and long-term health and psychosocial issues, such as difficulty reentering school, the workforce, or the dating scene; problems with infertility; cardiac, pulmonary, or other treatment repercussions; and secondary malignancies.Survivors are also at increased risk for psychiatric conditions such as anxiety, depression, substance abuse, and suicide and may have difficulty acquiring health insurance and paying for needed care. Identifying and Addressing the Needs of Adolescents and Young Adults with Cancer discusses a variety of topics important to adolescent and young adult patients with cancer, including the ways in which cancers affecting this group differ from cancers in other age groups and what that implies about the best treatments for these cancer patients. This report identifies gaps and challenges in providing optimal care to adolescent and young adult patients with cancer and to discuss potential strategies and actions to address them.

In the nearly 40 years since implementation of federal regulations governing the protection of human participants in research, the number of clinical studies has grown exponentially. These studies have become more complex, with multisite trials now common, and there is increasing use of archived biospecimens and related data, including genomics data. In addition, growing emphasis on targeted cancer therapies requires greater collaboration and sharing of research data to ensure that rare patient subsets are adequately represented. Electronic records enable more extensive data collection and mining, but also raise concerns about the potential for inappropriate or unauthorized use of data, bringing patient protections into a new landscape. There are also long-standing concerns about the processes and forms used to obtain informed consent from patients participating in clinical studies. These changes and challenges raise new ethical and practical questions for the oversight of clinical studies, and for protecting patients and their health information in an efficient manner that does not compromise the progress of biomedical research.Contemporary Issues for Protecting Patients in Cancer Research is the summary of a workshop convened by the National Cancer Policy Forum of the Institute of Medicine in February 2014 to explore contemporary issues in human subjects protections as they pertain to cancer research, with the goal of identifying potential relevant policy actions. Clinical researchers, government officials, members of Institutional Review Boards, and patient advocates met to discuss clinical cancer research and oversight. This report examines current regulatory provisions that may not adequately protect patients or may be hindering research, and discusses potential strategies and actions to address those challenges.

In recent years, patients' out-of-pocket costs for cancer care have been rising rapidly. These costs include health insurance deductibles, coinsurance, and copayments for covered services, as well as services that are not covered by insurance. Many cancer patients are especially vulnerable financially because their illness and/or treatment impedes their ability to work, with some patients losing employment altogether. Even with insurance, cancer patients often experience financial hardships, such as going into debt, depleting all assets to pay for cancer treatment, and personal bankruptcy. Although many elements contribute to the cost of cancer care, one important component is the cost of new cancer drugs, which has been escalating rapidly in recent years. To explore the issue of cancer drug costs and patient access to affordable, appropriate drug therapies, the Institute of Medicine's National Cancer Policy Forum convened a workshop on ensuring patient access to affordable cancer drugs in June 2014. Affordability was considered from both individual and societal perspectives.The workshop featured discussion panels as well as invited presentations from clinicians, researchers, representatives from the health insurance and pharmaceutical industries, and patient advocates. Ensuring Patient Access to Affordable Cancer Drugs summarizes the presentation and discussion of the workshop.

A long-held goal in oncology has been to develop therapies that target the specific abnormalities in each patient's cancer rather than simply treating cancers based on the tissue of origin. In the past decade, advances in technology have enabled researchers to relatively quickly and inexpensively determine, in minute detail, the genetic makeup of tumors. Although relatively few targeted cancer therapies are currently available in the clinic and it is not yet clear whether all cancers are driven by genetic changes that can be targeted, there is widespread optimism in the cancer community that this new ability to assess the genetic abnormalities in tumors will ultimately lead to better cancer treatments and improved patient outcomes. Policy Issues in the Development and Adoption of Biomarkers for Molecularly Targeted Cancer Therapies is the summary of a workshop convened in November 2014 by the Institute of Medicine's National Cancer Policy Forum to discuss recent trends in the development and implementation of molecularly targeted cancer therapies and explore potential policy actions to address specific challenges.This report highlights the presentations and discussions at the workshop.

Childhood cancer is an area of oncology that has seen both remarkable progress as well as substantial continuing challenges. While survival rates for some pediatric cancers present a story of success, for many types of pediatric cancers, little progress has been made. Many cancer treatments are known to cause not only significant acute side effects, but also lead to numerous long-term health risks and reduced quality of life. Even in cases where the cancer is considered curable, the consequences of treatment present substantial long-term health and psychosocial concerns for children, their families, their communities, and our health system. To examine specific opportunities and suggestions for driving optimal care delivery supporting survival with high quality of life, the National Cancer Policy Forum of the Institute of Medicine and the American Cancer Society co-hosted a workshop which convened experts and members of the public on March 9 and 10, 2015. At this workshop, clinicians and researchers in pediatric oncology, palliative, and psychosocial care, along with representatives from the U.S.Food and Drug Administration, National Cancer Institute, Children's Oncology Group, pharmaceutical companies, and patient advocacy organizations, discussed and developed a menu of options for action to improve research, quality of care, and outcomes for pediatric cancer patients and their families. In addition, parents of children with cancer and pediatric cancer survivors shared their experiences with care and provided poignant personal perspectives on specific quality of life concerns and support needs for children and families across the life spectrum. This report summarizes the presentations and discussion of the workshop.

Millions of women undergo screening mammography regularly with the hope of detecting breast cancer at an earlier and more curable stage. But the ability of such screening to accurately detect early cancers depends on the quality of mammography, including high-quality image acquisition and interpretation. To help ensure the quality of mammography, Congress passed the Mammography Quality Standards Act (MQSA) in 1994 and last reauthorized it in 2004. In advance of its expected reauthorization in 2007, Congress requested a consensus study from the Institute of Medicine (IOM) recommending ways to improve the quality of mammography, with an emphasis on image interpretation. The resulting report, Improving Breast Imaging Quality Standards, highlighted the need to decrease variability in mammography interpretation in the United States and identified gaps in the evidence needed to develop best practices. The consensus committee found that mammography interpretation remained quite variable, and that this variability limited the full potential of mammography to reduce breast cancer mortality by detecting breast cancers at an early stage.In May 2015, the IOM convened a workshop to address this issue. The participants discussed challenges in the delivery of high-quality mammography, the impact of training and experience on interpretive performance, how best to measure interpretive performance, and the potential impact of new technologies and supplemental imaging on interpretation of breast screening and diagnostic images. Assessing and Improving the Interpretation of Breast Images summarizes the presentations and discussions from this workshop.

Traditional preclinical mouse models of cancer have been very useful for studying the biology of cancer, however they often lack key characteristics of human cancers. As a result, many novel drug candidates fail in human clinical trials despite evidence of drug efficacy in those preclinical models. Thus, researchers are seeking new approaches to augment preclinical knowledge before undertaking clinical trials for human patients. Recently, there has been renewed interest in comparative oncology - the study of naturally developing cancers in animals as models for human disease - as one way to improve cancer drug development and reduce attrition of investigational agents. Tumors that spontaneously develop in pet dogs and other companion animals as a result of normal aging share many characteristics with human cancers, such as histological appearance, tumor genetics, biological behavior, molecular targets, and therapeutic response. In June 2015 the Institute of Medicine hosted a workshop to examine the rationale and potential for integrating clinical trials for pet patients with naturally occurring cancers into translational cancer research and development.Participants discussed the research needs, strategies, and resources to support greater integration of clinical trials for pets with cancer into translational research pathways, and challenges and potential solutions for facilitating that integration. This report summarizes the presentations and discussions from the workshop.

In recent years, the field of oncology has witnessed a number of technological advances, including more precise radiation therapy and minimally invasive surgical techniques. Three-dimensional (3D), stereotactic, and proton-beam radiation therapy, as well as laparoscopy and robotic surgery, can enhance clinician's ability to treat conditions that were clinically challenging with conventional technologies, and may improve clinical outcomes or reduce treatment-related problems for some patients. Both patients and physicians seek access to these new technologies, which are rapidly being adopted into standard clinical practice. Such demand is often propelled by marketing that portrays the new technologies as the a /latest and greatesta treatments available. However, evidence is often lacking to support these claims, and these novel technologies usually come with higher price tags and are often used to treat patients who might have achieved similar benefits from less expensive, conventional treatment.The increased cost of novel treatments without adequate assessment of how they affect patient outcomes is a pressing concern given that inappropriate use of expensive technologies is one of the key factors that threaten the affordability of cancer care in the United States. To explore these issues further, the National Cancer Policy Forum (NCPF) of the Institute of Medicine organized a workshop in July 2015. This is the third NCPF workshop in a series examining the affordability of cancer care. Participants explored clinical benefits and comparative effectiveness of emerging advanced technologies for cancer treatment in radiation therapy and surgery and potential strategies to assess the value and promote optimal use of new technologies in cancer treatment. This report 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. 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 a " on an individual or societal basis a " 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.