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The use of immune modulator therapeutics, a type of immunotherapy enhancing the body immune system response to cancer, was perceived as the beginning of a new era in cancer care. While still important and frequently used, some of these therapeutics produce uneven response rates, disease resistance, and serious side effects. The National Academies National Cancer Policy Forum, in collaboration with the Forum on Drug Discovery, Development, and Translation, hosted a public workshop to discuss challenges related to immunotherapy treatment resistance, as well as potential policy opportunities to improve the development of immunotherapies for cancer treatment.

Public-private partnerships (PPPs) are collaborations among public and private entities (e.g., government agencies, research institutions, nonprofit organizations, and industry organizations) that bring together diverse expertise, resources, and perspectives to solve complex challenges. The National Academies National Cancer Policy Forum, in collaboration with the Forum on Drug Discovery, Development, and Translation, hosted a public workshop in October 2023 to examine opportunities to improve the care and outcomes for patients with cancer through PPPs for clinical cancer research.

The National Academies Roundtable on Genomics and Precision Health, in collaboration with the National Cancer Policy Forum, hosted a public workshop that examined how genomic data are used in health care, outside of the traditional settings for clinical genetics. The workshop identified opportunities for advancement of precision health care delivery. The event also explored how patients, clinicians, and payers assess and act upon the risks and benefits of genomic screening and diagnostic testing. Discussions focused on strategies to ensure that genomic applications are responsibly and equitably adopted to benefit populations as well as individuals over time. This Proceedings of a Workshop summarizes content from the event.

Where people live can affect their health because of location-specific exposure to chemicals and toxicants, lifestyle, diet, immune function development, and social and historical determinants of health. A better understanding of the connections between environmental exposures and genetics that are associated with cancer can help inform efforts to identify risks and prevent potentially harmful outcomes. Recent scientific advancements have brought new insights into genomic and epigenomic biomarkers of cancer, which encompasses the toxicogenomic effects of environmental hazards, genetic susceptibility to environmental exposures, and the role of genetic and epigenetic changes in the development of cancer. Public communication around the potential risks of environmental hazards has also been evolving. The National Academies of Sciences, Engineering, and Medicine National Cancer Policy Forum convened a virtual public workshop in collaboration with the Roundtable on Genomics and Precision Health on April 13, 2023 to explore the state of the science in identifying potential genomic and epigenomic biomarkers of environmental exposures associated with cancers, with an emphasis on pediatric cancers. This proceedings document summarizes workshop discussions.

The COVID-19 pandemic has led to dramatic adjustments in cancer care delivery and cancer research. To examine these changes, the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine convened a virtual workshop, Innovation in Cancer Care and Cancer Research in the Context of the COVID-19 Pandemic, in July 2021. Workshop speakers considered the lessons learned from these adaptations in order to improve the delivery of high-quality cancer care and the conduct of cancer clinical trials in the post-pandemic era. This Proceedings of a Workshop highlights presentations and discussions from the workshop.

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.

There is a void in evidence-based information for making informed decisions on how to optimize care for older adults, particularly those 80 years and over. Because older adults are vastly underrepresented in clinical trials, there is a dearth of information about the appropriate use of drugs in this population. Yet older adults have higher rates of comorbidities and simultaneous use of multiple medications than the general population, and are the majority users of many medications. Additionally, age-related physiological and pathological changes, particularly for adults 80 years of age and older, can lead to significant differences in the pharmacokinetics (PK)2 and pharmacodynamics (PD)3 of a given drug compared to the general population. On August 5 and 6, 2020, the National Academies of Sciences, Engineering, and Medicine hosted a workshop titled Drug Research and Development for Adults Across the Older Age Span. The workshop was designed to examine the challenges and opportunities in drug research and development for older adult populations, explore barriers that impede safety and efficacy studies in these populations, and share lessons learned for better understanding clinical pharmacology for populations over age 65. This publication summarizes the presentation and discussion of the workshop.

Astronauts face unique health-related risks during crewed space missions, and longer-duration missions that extend to greater distances in our solar system (including to the Moon and Mars) will likely increase those risks. Cancer risks due to ionizing radiation exposure are one of these health-related risks. Assessing, managing, and communicating radiation-induced cancer risks associated with spaceflight are challenging because of incomplete knowledge of the radiation environment in space, limited data on radiation-induced cellular damage mechanisms, lack of direct observations from epidemiological studies, and the complexities of understanding radiation risk. At the request of the National Aeronautics and Space Administration (NASA), an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine convened to provide advice on NASA's proposed updates to their space radiation health standard, which sets the allowable limit of space radiation exposure throughout the course of an astronaut's career. Space Radiation and Astronaut Health: Managing and Communicating Cancer Risks provides the committee's recommendations and conclusions regarding the updated space radiation health standard, NASA's radiation risk communication strategies, and a process for developing an ethics-informed waiver protocol for long-duration spaceflight missions.

Sharing knowledge is what drives scientific progress - each new advance or innovation in biomedical research builds on previous observations. However, for experimental findings to be broadly accepted as credible by the scientific community, they must be verified by other researchers. An essential step is for researchers to report their findings in a manner that is understandable to others in the scientific community and provide sufficient information for others to validate the original results and build on them. In recent years, concern has been growing over a number of studies that have failed to replicate previous results and evidence from larger meta-analyses, which have pointed to the lack of reproducibility in biomedical research. On September 25 and 26, 2019, the National Academies of Science, Engineering, and Medicine hosted a public workshop in Washington, DC, to discuss the current state of transparency in the reporting of preclinical biomedical research and to explore opportunities for harmonizing reporting guidelines across journals and funding agencies. Convened jointly by the Forum on Drug Discovery, Development, and Translation; the Forum on Neuroscience and Nervous System Disorders; the National Cancer Policy Forum; and the Roundtable on Genomics and Precision Health, the workshop primarily focused on transparent reporting in preclinical research, but also considered lessons learned and best practices from clinical research reporting. This publication summarizes the presentation and discussion of the workshop.

On November 18 and 19, 2019, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop in Washington, DC, titled Sharing Clinical Trial Data: Challenges and a Way Forward. The workshop followed the release of the 2015 Institute of Medicine (IOM) consensus study report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, and was designed to examine the current state of clinical trial data sharing and reuse and to consider ways in which policy, technology, incentives, and governance could be leveraged to further encourage and enhance data sharing. This publication summarizes the presentations and discussions from the workshop.

Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and'low-hanging fruit'opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

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 Researchlooks at the role of these new large-scale projects in the biomedical sciences. Though written by the National Academies'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 Scienceare 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.

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.