Publications from the National Academies of Sciences, Engineering, and Medicine provide objective and straightforward advice to decision makers and the public. This site includes Health and Medicine Division (HMD) publications released after 1998. A complete list of HMD’s publications from its establishment in 1970 to the present is available as a PDF.
Health Standards for Long Duration and Exploration ...
Released: April 02, 2014
As the US space program evolves, propelled in part by increasing international and commercial collaborations, long duration or exploration spaceflights – such as extended stays on the International Space Station or missions to Mars – become more realistic. These types of missions will likely expose crews to levels of known risk that are beyond those allowed by current health standards, as well as to a range of risks that are poorly characterized, uncertain, and perhaps unforeseeable. NASA asked the IOM to outline the ethics principles and practices that should guide the agency’s decision making for future long duration or exploration missions that fail to meet existing health standards. The IOM’s report identifies the an ethics framework, which builds on the work of NASA and others, and presents a set of recommendations for ethically assessing and responding to the challenges associated with health standards for long duration and exploration spaceflight.
Discussion Framework for Clinical Trial Data Sharing: Guiding ...
Released: January 22, 2014
Clinical trials are crucial to determining the safety of medical interventions and their ability to achieve particular health outcomes and represent a significant investment from all involved — patients and others who volunteer to participate, organizations that sponsor trials, and the researchers who conduct a study and analyze the data. Clinical trial data represent potential resources that, if shared, could facilitate new analyses and a deeper understanding of a particular therapy or condition. However, much of the data generated by clinical trials is not public or shared beyond the data holder, and significant barriers to sharing these data exist. In follow up to an October 2012 workshop at the IOM, the IOM is conducting a consensus study to recommend guiding principles and a framework for the responsible sharing of clinical trial data. A final report will be released in December 2014. This framework for discussion outlines the committee’s preliminary thoughts on guiding principles that underpin the responsible sharing of clinical trial data, defines key elements of data and data sharing activities, and describes a selected set of data sharing activities. One goal of this framework is to facilitate identification of the numerous complicated issues that the committee might need to take into account in the strategies and practical approaches to sharing of clinical trial data that will be recommended in the committee’s final report.
Improving and Accelerating Therapeutic Development for ...
Released: November 25, 2013
Although there is a high burden associated with nervous system disorders, development of new therapeutics remains stagnant. Over the last decade, fewer new drugs for nervous system disorders have garnered approval in comparison to other therapeutic areas. Current data suggest that drug development, from the start of a discovery program to regulatory approval, can take an average of 12 to 15 years. Building off of concepts discussed at a 2012 IOM workshop, the IOM Forum on Neuroscience and Nervous System Disorders held a workshop to examine opportunities to accelerate early phases of drug development for nervous system drug discovery.
Identifying and Addressing the Needs of Adolescents and ...
Released: November 04, 2013
Cancer is the leading disease-related cause of death in adolescents and young adults (AYAs). Each year, nearly 70,000 AYAs between the ages of 15 and 39 are diagnosed with cancer. Adolescents and young adults face a variety of unique short- and long-term health and psychosocial issues. Many programs for cancer treatment, survivorship care, and psychosocial support do not focus on the specific needs and risks of AYA cancer patients. The IOM’s National Cancer Policy Forum held a workshop to facilitate discussion about gaps and challenges in caring for AYA cancer patients and potential strategies and actions to improve the quality of their care.
Neurodegeneration: Exploring Commonalities Across ...
Released: October 03, 2013
Neurodegenerative diseases – such as Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and frontotemporal dementia (FTD) – are becoming increasingly more prevalent in the United States due to the aging population. Implications of these diseases are grave, both for individual and family quality of life and for healthcare costs. Recent findings have revealed potential commonalities and parallelisms in genetic and cellular mechanisms across neurodegenerative diseases. In 2012, the IOM hosted a workshop to explore commonalities across neurodegenerative diseases and to identify potential opportunities for collaboration across the respective research and development communities.
Observational Studies in a Learning Health System ...
Released: September 24, 2013
Clinical research is constantly advancing, although perhaps not fast enough to meet the challenges and seize the opportunities presented. New tools are emerging. While challenges remain, these tools have the potential to accelerate the research process and to allow an approach to clinical research that applies the most appropriate methods given the requirements of the situation. This approach includes the leveraging of the information collected in the process of delivering care to drive processes for new insights and continuous improvement, which is at the heart of a learning health system. An IOM workshop, sponsored by the Patient Centered Outcomes Research Institute, was convened to identify the leading approaches to observational studies, chart the course for the use of this growing utility, and guide and grow their use in the most responsible fashion possible.
Large Simple Trials and Knowledge Generation in a Learning ...
Released: September 24, 2013
Despite a robust clinical research enterprise, a gap exists between the evidence needed to support care decisions and the evidence available. Streamlined approaches to clinical research provide options for progress on these challenges. Large simple trials (LSTs), for example, generally have simple randomization, broad eligibility criteria, enough participants to distinguish small to moderate effects, focus on outcomes important to patient care, and use simplified approaches to data collection. Significant opportunities, including the wide-spread adoption of electronic health records, could accelerate the potential for the use of LSTs to efficiently generate practical evidence for medical decision making and product development. To address these opportunities, as well as challenges, the IOM held a workshop to highlight the pros and cons of the design characteristics of LSTs, explored the utility of LSTs on the basis of case studies of past successes, and considered the challenges and opportunities for accelerating the use of LSTs in the context of a U.S. clinical trials enterprise.
Partnering with Patients to Drive Shared Decisions, Better ...
Released: August 15, 2013
In an efficient health care system, care choices are democratized and based on the best evidence. Though the infrastructure and cultural changes necessary to transform the patient role are significant, empowering patients to become partners in—rather than customers of—the health care system is a critical step on the road to achieving the best care at lower cost. Increased patient engagement in care decisions, value, and research is crucial to the pursuit of better care, improved health, and lower health care costs. This publication details discussions at the February 2013 IOM workshop which gathered patients and experts in areas such as decision science, evidence generation, communication strategies, and health economics to consider the central roles for patients in bringing about progress in all aspects of the U.S. health care system.
Strengthening Human Resources Through Development of ...
Released: August 14, 2013
Sub-Saharan Africa has one of the largest treatment gaps for mental, neurological, and substance use (MNS) disorders in the world. The ability to provide adequate human resources for the delivery of essential interventions for MNS disorders is a critical barrier to bridging the treatment gap. In 2012, the IOM hosted a second workshop in Kampala, Uganda, to discuss candidate core competencies that providers might need to help ensure the effective delivery of services for MNS disorders. The workshop focused on candidate competencies for four MNS disorders that account for the greatest burden in low- and middle-income countries: depression, psychosis, epilepsy, and alcohol use disorders.
Implementing a National Cancer Clinical Trials System for the ...
Released: July 15, 2013
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 National Cancer Institute asked the IOM to develop a set of recommendations to improve the federally funded cancer clinical trials system. These recommendations were published in a 2010 IOM report. In 2011, the IOM’s National Cancer Policy Forum (NCPF) held a workshop to engage stakeholders in discussions about the changes they planned to implement in response to the IOM report. Two years later, the NCPF held a second workshop in which stakeholders reported the changes that they have made thus far to address the IOM recommendations, and discussed additional actions needed to improve the system.