Margie Patlak - Böcker

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.

To explore whether soccer playing puts youths at risk for lasting brain damage, the Institute of Medicine brought together experts in head injury, sports medicine, pediatrics, and bioengineering. In a workshop entitled "Youth Soccer: Neuropsychological Consequences of Head Impact in Sports," that was held in Washington D.C. on October 12, 2001, these experts presented the scientific evidence for long-term consequences of head injury from youth sports, especially soccer, possible approaches to reduce the risks, and policy issues raised by the subject. Some of the findings presented by the speakers raised concerns, such as the high concussion rate of high school soccer players, the frequent persistence of impaired brain functions even after other symptoms of a concussion disappear, and the need for a better understanding of when it is safe for players to resume playing after they have had a concussion. But other findings were reassuring, such as studies that suggest that with the type of soccer balls used in the United States, heading is not likely to cause brain injury in youths, nor is playing soccer likely to cause permanent brain damage.This is a summary of the reports from these experts in the field, and the lively discussions that followed them. Topics covered include: causes of head injuries in soccer; how to detect a concussion; the biology of concussion; studies of soccer and football players; the role of protective headgear; and policy implications, such as how to decide when a concussed player should be allowed to return to the playing field.

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.

Scientists and clinicians seek a new paradigm that could improve the efficiency, cost-effectiveness, and overall success rate of cancer clinical trials, while maintaining the highest standards of quality. To explore innovative paradigms for cancer clinical trials and other ways to improve their quality, the National Cancer Policy Forum held a workshop, Improving the Quality of Cancer Clinical Trials, in Washington, DC. The main goals of the workshop were to examine new approaches to clinical trial design and execution that would: (1) better inform decisions and plans of those responsible for developing new cancer therapies (2) more rapidly move new diagnostic tests and treatments toward regulatory approval and use in the clinic (3) be less costly than current trials The resulting workshop summary will serve as input to the deliberations of an Institute of Medicine committee that will develop consensus-based recommendations for moving the field of cancer clinical trials forward.

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.

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.

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.

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.

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.

The Gulf of Mexico oil spill is unprecedented not only in its size but also in the use of chemical dispersants and controlled burns to remove the oil. The National Institute of Environmental Health Sciences (NIEHS) is designing a study to investigate the health effects on clean-up workers. The IOM held a workshop to review and comment on NIEHS'o;s study protocol.

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.

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.

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.

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.

Cancer treatment can lead to an array of significant short- and long-term physical, psychosocial, and socioeconomic consequences for patients and their families. To examine the opportunities to prevent and mitigate the adverse effects of cancer treatment, the National Academies of Sciences, Engineering, and Medicine hosted a virtual workshop, Addressing the Adverse Consequences of Cancer Treatment, in November 2020. This workshop was convened by the Academies' National Cancer Policy Forum in collaboration with the Forum on Aging, Disability, and Independence. Workshop presentations and discussions described the range of adverse effects that patients with cancer may experience across the life course, and highlighted potential strategies to improve quality of life for cancer survivors and their families.

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.

Over the last three decades, researchers have made remarkable progress in creating and testing family-focused programs aimed at fostering the cognitive, affective, and behavioral health of children. These programs include universal interventions, such as those for expecting or new parents, and workshops for families whose children are entering adolescence, as well as programs targeted to especially challenged parents, such as low-income single teens about to have their first babies, or the parents of children with autism. Some family-focused programs have been shown to foster significantly better outcomes in children, including enhanced educational performance, and reduced rates of teen pregnancy, substance abuse, and child conduct and delinquency, as well as reduced child abuse. The favorable cost-benefit ratios of some of these programs are due, in part, to the multiple and far-ranging effects that family-focused prevention programs targeting children can have. Other family-focused programs have shown success in smaller academic studies but have not been widely applied, or have not worked as effectively or failed when applied to more diverse real-world settings.Strategies for Scaling Effective Family-Focused Preventive Interventions to Promote Children's Cognitive, Affective, and Behavioral Health is the summary of a workshop convened by the Institute of Medicine Forum on Promoting Children's Cognitive, Affective, and Behavioral Health to explore effective preventive interventions for youth that can modify risk and promote protective factors that are linked to mental, emotional, and behavioral health, and how to apply this existing knowledge. Based on the 2009 report Preventing Mental, Emotional, and Behavioral Disorders Among Young People, this report considers how to build a stronger research and practice base around the development and implementation of programs, practices, and policies that foster children's health and well-being across the country, while engaging multi-sectorial stakeholders.While research has advanced understanding of risk, promotive, and protective factors in families that influence the health and well-being of youth, a challenge remains to provide family-focused interventions across child and adolescent development at sufficient scale and reach to significantly reduce the incidence and prevalence of negative cognitive, affective, and behavioral outcomes in children and adolescents nationwide, as well as to develop widespread demand for effective programs by end users. This report explores new and innovative ways to broaden the reach and demand for effective programs and to generate alternative paradigms for strengthening families.

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.

Over the past few decades there have been major successes in creating evidence-based interventions to improve the cognitive, affective, and behavioral health of children. Many of these interventions have been put into practice at the local, state, or national level. To reap what has been learned from such implementation, and to explore how new legislation and policies as well as advances in technology and analytical methods can help drive future implementation, the Institute of Medicine-National Research Council Forum on Promoting Children's Cognitive, Affective, and Behavioral Health held the workshop "Harvesting the Scientific Investment in Prevention Science to Promote Children's Cognitive, Affective, and Behavioral Health" in Washington, DC, on June 16 and 17, 2014. The workshop featured panel discussions of system-level levers and blockages to the broad implementation of interventions with fidelity, focusing on policy, finance, and method science; the role of scientific norms, implementation strategies, and practices in care quality and outcomes at the national, state, and local levels; and new methodological directions.The workshop also featured keynote presentations on the role of economics and policy in scaling interventions for children's behavioral health, and making better use of evidence to design informed and more efficient children's mental health systems. Harvesting the Scientific Investment in Prevention Science to Promote Children's Cognitive, Affective, and Behavioral Health summarizes the presentations 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.