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Sponsor Influences on the Quality and Independence of Health Research
  • Language: en

Sponsor Influences on the Quality and Independence of Health Research

  • Type: Book
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  • Published: 2024-03
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  • Publisher: Unknown

Governments, philanthropic organizations, and private industry fund human health and medical research. Various funding sources might bias research so that the results are more favorable to their agents. Funders may influence investigative scope, specific questions posed, experimental design, and principal investigator appointments. Reporting, analysis, dissemination, and communication and data availability, reanalysis, and replication can also experience bias from a funding source. To explore structures, processes, and principles to ensure high-quality health research independent of sponsor influence, the National Academies Board on Population Health and Public Health Practice and the Board on Health Sciences Policy hosted a public virtual workshop in December 2022 that examined the sources of funding for health research and evidence on whether they influence the quality and outcomes of resulting health research. The workshop also discussed models, process, and principles used to protect the independence and quality of research. This Proceedings summarizes the discussions held during the workshop.

Toward Equitable Innovation in Health and Medicine
  • Language: en

Toward Equitable Innovation in Health and Medicine

  • Type: Book
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  • Published: 2024-05-22
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  • Publisher: Unknown

Advances in biomedical science, data science, engineering, and technology are leading to high-pace innovation with potential to transform health and medicine. These innovations simultaneously raise important ethical and social issues, including how to fairly distribute their benefits and risks. The National Academies of Sciences, Engineering, and Medicine, in collaboration with the National Academy of Medicine, established the Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine to provide leadership and engage broad communities in developing a framework for aligning the development and use of transformative technologies with ethical and equitable principles. The committees resulting report describes a governance framework for decisions throughout the innovation life cycle to advance equitable innovation and support an ecosystem that is more responsive to the needs of a broader range of individuals and is better able to recognize and address inequities as they arise.

Enhancing the Vitality of the National Institutes of Health
  • Language: en
  • Pages: 164

Enhancing the Vitality of the National Institutes of Health

The report says that important organizational changes are needed at the National Institutes of Health to ensure the agency meets future challenges effectively. In particular, the report advises NIH to devote additional resources to innovative interdisciplinary research that reflects its strategic objectives and cuts across all agency's institutes and centers. The report recommends that Congress should establish a formal process for determining how specific proposals for changes in the number of NIH agencies and centers should be addressed.

An Examination of Emerging Bioethical Issues in Biomedical Research
  • Language: en
  • Pages: 133

An Examination of Emerging Bioethical Issues in Biomedical Research

On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 1-day public workshop in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, but this workshop focused on issues related to the development and use of digital technologies, artificial intelligence, and machine learning in research and clinical practice; issues emerging as nontraditional approaches to health research become more widespread; the role of bioethics in addressing racial and structural inequalities in health; and enhancing the capacity and diversity of the bioethics workforce. This publication summarizes the presentations and discussions from the workshop.

Real-World Evidence Generation and Evaluation of Therapeutics
  • Language: en
  • Pages: 103

Real-World Evidence Generation and Evaluation of Therapeutics

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.

Safeguarding the Bioeconomy
  • Language: en
  • Pages: 393

Safeguarding the Bioeconomy

Research and innovation in the life sciences is driving rapid growth in agriculture, biomedical science, information science and computing, energy, and other sectors of the U.S. economy. This economic activity, conceptually referred to as the bioeconomy, presents many opportunities to create jobs, improve the quality of life, and continue to drive economic growth. While the United States has been a leader in advancements in the biological sciences, other countries are also actively investing in and expanding their capabilities in this area. Maintaining competitiveness in the bioeconomy is key to maintaining the economic health and security of the United States and other nations. Safeguarding...

Engaging the Private-Sector Health Care System in Building Capacity to Respond to Threats to the Public's Health and National Security
  • Language: en
  • Pages: 155

Engaging the Private-Sector Health Care System in Building Capacity to Respond to Threats to the Public's Health and National Security

Disasters tend to cross political, jurisdictional, functional, and geographic boundaries. As a result, disasters often require responses from multiple levels of government and multiple organizations in the public and private sectors. This means that public and private organizations that normally operate independently must work together to mount an effective disaster response. To identify and understand approaches to aligning health care system incentives with the American public's need for a health care system that is prepared to manage acutely ill and injured patients during a disaster, public health emergency, or other mass casualty event, the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop on March 20 and 21, 2018. This publication summarizes the presentations and discussions from the workshop.

The Role of Digital Health Technologies in Drug Development
  • Language: en
  • Pages: 143

The Role of Digital Health Technologies in Drug Development

On March 24, 2020, a 1-day public workshop titled The Role of Digital Health Technologies in Drug Development was convened by the National Academies of Sciences, Engineering, and Medicine. This workshop builds on prior efforts to explore how virtual clinical trials facilitated by digital health technologies (DHTs) might change the landscape of drug development. To explore the challenges and opportunities in using DHTs for improving the probability of success in drug R&D, enabling better patient care, and improving precision medicine, the workshop featured presentations and panel discussions on the integration of DHTs across all phases of drug development. Throughout the workshop, participants considered how DHTs could be applied to achieve the greatest impactâ€"and perhaps even change the face of how clinical trials are conductedâ€"in ways that are also ethical, equitable, safe, and effective. This publication summarizes the presentations and discussions from the workshop.

Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting
  • Language: en
  • Pages: 143

Enhancing Scientific Reproducibility in Biomedical Research Through Transparent Reporting

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 la...

Examining Challenges and Possible Strategies to Strengthen U.S. Health Security
  • Language: en
  • Pages: 125

Examining Challenges and Possible Strategies to Strengthen U.S. Health Security

As the United States continues to adapt to a more digital, mobile, and interconnected world, health care and public health professionals have sought to better prepare for and respond to long-standing and emerging threats to the nation's health security. Health security is the collective effort to prevent, protect against, mitigate, respond to, and recover from the health consequences of natural, man-made, and technological disasters. Although substantial progress has been made in the past 15 years toward improving health care and public health systems and capacities for health security threats, many complex challenges persist, and often the nation's preparedness efforts are not sufficient. On March 8â€"9, 2017, the National Academies of Sciences, Engineering, and Medicine's Forum on Medical and Public Health Preparedness for Disasters and Emergencies hosted a two-day public workshop to acknowledge these persistent issues; to evaluate past, and perhaps inadequate, approaches to addressing them; and to discuss intentional and innovative new solutions. This publication summarizes the presentations and discussions from the workshop.