Nonhuman primates represent a small fraction of animals used in biomedical research, but they remain important research models due to their similarities to humans with respect to genetic makeup, anatomy, physiology, and behavior. Limitations in the availability of nonhuman primates have been exacerbated by the COVID-19 pandemic and recent restrictions on their exportation and transportation, impacting National Institutes of Health (NIH)-funded research necessary for both public health and national security. Additionally, there is continued interest in understanding whether and how nonanimal models can be used to answer scientific questions for which nonhuman primates are currently used. At the direction of the U.S. Congress, NIH asked the National Academies of Sciences, Engineering, and Medicine to convene an expert committee to conduct a landscape analysis of current and future use of nonhuman primates in NIH-supported biomedical research, as well as opportunities for new approach methodologies to complement or reduce reliance on nonhuman primate models. This report provides the committee findings and conclusions. Table of Contents Front Matter Summary 1 Introduction 2 Contribution of Nonhuman Primate Models to Advances in Human Health 3 Current Landscape of Use and Availability of Nonhuman Primates for NIH-Supported Biomedical Research 4 The Landscape of New Approach Methodologies 5 Future Needs and Opportunities for Nonhuman Primate Models in Biomedical Research Appendix A: Study Approach and Methods Appendix B: Data on Nonhuman Primate Use in NIH-Supported Biomedical Research Appendix C: Biographical Sketches of Committee Members and Staff Appendix D: Disclosure of Unavoidable Conflicts of Interest

The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop. Table of Contents Front Matter 1 Introduction 2 Improving Evidence Generation for Decision Making on Approval and Use of New Treatments: Some Stakeholder Priorities 3 Opportunities for Real-World Data 4 Generating and Incorporating Real-World Evidence into Medical Product Development and Evaluation: Building from Successful Case Studies 5 Potential Strategies for a Way Forward Appendix A: Bibliography Appendix B: Workshop Agenda Appendix C: Participant Biographies Appendix D: Discussion Paper: Real-World Evidence to Guide theApproval and Use of New Treatments

Societies around the world are concerned about dementia and the other forms of cognitive impairment that affect many older adults. We now know that brain changes typically begin years before people show symptoms, which suggests a window of opportunity to prevent or delay the onset of these conditions. Emerging evidence that the prevalence of dementia is declining in high-income countries offers hope that public health interventions will be effective in preventing or delaying cognitive impairments. Until recently, the research and clinical communities have focused primarily on understanding and treating these conditions after they have developed. Thus, the evidence base on how to prevent or delay these conditions has been limited at best, despite the many claims of success made in popular media and advertising. Today, however, a growing body of prevention research is emerging. Preventing Cognitive Decline and Dementia: A Way Forward assesses the current state of knowledge on interventions to prevent cognitive decline and dementia, and informs future research in this area. This report provides recommendations of appropriate content for inclusion in public health messages from the National Institute on Aging. Table of Contents Front Matter Summary 1 Introduction 2 Communicating with the Public about Interventions to Prevent Cognitive Decline and Dementia 3 Methodological Improvements 4 Priorities for Future Research Appendix A: Agency for Healthcare Research and Quality (AHRQ) Systematic Review Appendix B: Public Meeting Agendas Appendix C: Biosketches of Committee Members

Advances in trauma care have accelerated over the past decade, spurred by the significant burden of injury from the wars in Afghanistan and Iraq. Between 2005 and 2013, the case fatality rate for United States service members injured in Afghanistan decreased by nearly 50 percent, despite an increase in the severity of injury among U.S. troops during the same period of time. But as the war in Afghanistan ends, knowledge and advances in trauma care developed by the Department of Defense (DoD) over the past decade from experiences in Afghanistan and Iraq may be lost. This would have implications for the quality of trauma care both within the DoD and in the civilian setting, where adoption of military advances in trauma care has become increasingly common and necessary to improve the response to multiple civilian casualty events. Intentional steps to codify and harvest the lessons learned within the military's trauma system are needed to ensure a ready military medical force for future combat and to prevent death from survivable injuries in both military and civilian systems. This will require partnership across military and civilian sectors and a sustained commitment from trauma system leaders at all levels to assure that the necessary knowledge and tools are not lost. A National Trauma Care System defines the components of a learning health system necessary to enable continued improvement in trauma care in both the civilian and the military sectors. This report provides recommendations to ensure that lessons learned over the past decade from the military's experiences in Afghanistan and Iraq are sustained and built upon for future combat operations and translated into the U.S. civilian system. Table of Contents Front Matter Abstract Summary Part I: Introduction, Overview, and Framework 1 Introduction 2 Overview of Contemporary Civilian and Military Trauma Systems 3 A Framework for a Learning Trauma Care System Part II: Assessment 4 Generating and Applying Knowledge to Improve Trauma Outcomes 5 Creating and Sustaining an Expert Trauma Care Workforce 6 Delivering Patient-Centered Trauma Care 7 Leveraging Leadership and Fostering a Culture of Learning Part III: Recommendations 8 A Vision for a National Trauma Care System Appendixes Appendix A: Case Studies Appendix B: Committee Collective Analysis of Case Studies Appendix C: MilitaryCivilian Exchange of Knowledge and Practices in Trauma Care Appendix D: Military and Civilian Trauma Care in the Context of a Continuously Learning Health System Appendix E: Public Committee Meeting Agendas Appendix F: Committee Biosketches

When communities face complex public health emergencies, state local, tribal, and territorial public health agencies must make difficult decisions regarding how to effectively respond. The public health emergency preparedness and response (PHEPR) system, with its multifaceted mission to prevent, protect against, quickly respond to, and recover from public health emergencies, is inherently complex and encompasses policies, organizations, and programs. Since the events of September 11, 2001, the United States has invested billions of dollars and immeasurable amounts of human capital to develop and enhance public health emergency preparedness and infrastructure to respond to a wide range of public health threats, including infectious diseases, natural disasters, and chemical, biological, radiological, and nuclear events. Despite the investments in research and the growing body of empirical literature on a range of preparedness and response capabilities and functions, there has been no national-level, comprehensive review and grading of evidence for public health emergency preparedness and response practices comparable to those utilized in medicine and other public health fields. Evidence-Based Practice for Public Health Emergency Preparedness and Response reviews the state of the evidence on PHEPR practices and the improvements necessary to move the field forward and to strengthen the PHEPR system. This publication evaluates PHEPR evidence to understand the balance of benefits and harms of PHEPR practices, with a focus on four main areas of PHEPR: engagement with and training of community-based partners to improve the outcomes of at-risk populations after public health emergencies; activation of a public health emergency operations center; communication of public health alerts and guidance to technical audiences during a public health emergency; and implementation of quarantine to reduce the spread of contagious illness. Table of Contents Front Matter Abstract Summary 1 Advancing Public Health Emergency Preparedness and Response System Capabilities to Respond to Increasing Threats 2 The Landscape and Evolution of Public Health Emergency Preparedness and Response Research in the United States 3 An Evidence Review and Evaluation Process to Inform Public Health Emergency Preparedness and Response Decision Making 4 Engaging with and Training Community-Based Partners to Improve the Outcomes of At-Risk Populations 5 Activating a Public Health Emergency Operations Center 6 Communicating Public Health Alerts and Guidance with Technical Audiences During a Public Health Emergency 7 Implementing Quarantine to Reduce or Stop the Spread of a Contagious Disease 8 Improving and Expanding the Evidence Base for Public Health Emergency Preparedness and Response Appendix A: Detailed Description of the Committee's Methods for Formulating the Scope of the Reviews and Capturing the Evidence Appendix B: Mixed-Method Reviews of Selected Topics Appendix B1: Mixed-Method Review of Strategies for Engaging with and Training Community-Based Partners to Improve the Outcomes of At-Risk Populations Appendix B2: Mixed-Method Review of Activating a Public Health Emergency Operations Center Appendix B3: Mixed-Method Review of Channels for Communicating Public Health Alerts and Guidance with Technical Audiences During a Public Health Emergency Appendix B4: Mixed-Method Review of Implementing Quarantine to Reduce or Stop the Spread of a Contagious Disease Appendix C: Commissioned Reports That Informed the Four Mixed-Method Reviews Appendix D: Commissioned Scoping Review and Series of Evidence Maps Appendix E: Public Committee Meeting Agendas and Proceedings of a Workshop - in Brief Appendix F: Committee Member Biosketches

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.