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.
Conflict of Interest and Medical Innovation: Ensuring Integrity ...
Released: March 21, 2014
The translation of research advances into clinical applications has been slower than anticipated due in part to the complexity of biology as well as the cost and time it takes to develop a product. Pharmaceutical companies, for example, are adapting their business models to improve the efficiency of product development by putting increasing emphasis on alliances, joint development efforts, early-phase research partnerships, and public-private partnerships. Though the potential benefits of collaboration are significant, the fact that partnerships are becoming more complex with both financial and non-financial relationships, even perceptions of conflict of interest or bias could impact the ability to engage in innovative research collaborations. In June 2013, the IOM Roundtable on Translating Genomic-Based Research for Health held a workshop to explore how to advance medical innovation while protecting the integrity of the research process and maintaining public trust.
Refining Processes for the Co-Development of Genome ...
Released: February 12, 2014
Genomic data can be used to identify new drug targets for both common and rare diseases, can predict which patients are likely to respond to a specific treatment, and have the potential to significantly reduce the cost of clinical trials. Recently, the realization of such benefits has led to the development and approval of several targeted therapeutics. A key component of each of these new drug approvals is the ability to identify the population of patients who will benefit from treatment, which is largely hinged on the co-development and co-submission to the U.S. FDA of a companion diagnostic test. This process has led to a change in the way drugs are developed with pharmaceutical and diagnostic companies working in close collaboration together. This summary describes an IOM workshop held to examine challenges and potential solutions for the co-development of targeted therapeutics and companion molecular tests for the prediction of drug response.
Advancing Workforce Health at the Department of Homeland ...
Released: January 29, 2014
The U.S. Department of Homeland Security (DHS) is responsible for protecting the health, safety, and resilience of its employees as well as guaranteeing effective management of the medical needs of those under DHS care or custody. The DHS Office of Health Affairs asked the IOM to recommend ways to better integrate occupational health functions and operational medicine throughout DHS with the necessary centralized oversight authority. The IOM’s report concludes that in order to ensure mission readiness and to provide DHS employees with occupational health support, strategic alignment through committed leadership, organizational and functional alignment, and management of health and safety information are needed.
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.
Caffeine in Food and Dietary Supplements: Examining Safety ...
Released: January 17, 2014
Caffeine is arguably the most ingested pharmacologically active substance in the world and has been a part of many cultures for centuries. But the caffeine-in food landscape is quickly changing. Along with energy drinks and supplements, the array of new caffeine-containing products is rapidly expanding. Historically, scientific research has shown that moderate consumption naturally-occurring caffeine in coffee and tea by healthy adults is not associated with adverse health effects. However, the inclusion of caffeine in products such as soft drinks and other beverages, foods, and supplements raises concerns about safety, whether new products target populations not normally associated with high caffeine consumption – like children and adolescents – and whether caffeine poses a greater health risk to those populations. The IOM held a workshop August 5-6, 2013, to review the available science on safe levels of caffeine consumption in foods, beverages, and dietary supplements and to identify data gaps.
Review of NASA's Evidence Reports on Human Health Risks ...
Released: January 06, 2014
In 2008, NASA asked the IOM to assess the process for developing evidence reports that NASA has compiled on human health risks for long-duration and exploration space flights. The resulting IOM report, Review of NASA’s Human Research Program Evidence Books: A Letter Report, provided an initial and brief review of the evidence report. This 2013 letter report builds on the work of the 2008 report and examines three NASA evidence reports: Risk of Injury from Dynamic Loads; Risk of Spaceflight-induced Intracranial Hypertension/Vision Alterations; and Risk of Clinically Relevant Unpredicted Effects of Medication. Over the next five years, the IOM will issue 4 additional letter reports and evaluate more than 30 NASA evidence reports, in total.
The Global Crisis of Drug-Resistant Tuberculosis and ...
Released: December 19, 2013
Although antibiotics to treat tuberculosis (TB) were developed in the 1950s and are effective against a majority of TB cases, resistance to these antibiotics has emerged over the years, resulting in the growing spread of drug-resistant TB. Since 2008, the IOM Forum on Drug Discovery, Development, and Translation has hosted or co-hosted six domestic and international workshops to address the global crisis of drug-resistant TB. On January 16-18, 2013, The IOM along with the Institute of Microbiology of the Chinese Academy of Sciences held a workshop to address the current status of drug-resistant TB globally and in China as well as identify opportunities for Brazil, Russia, India, China, and South Africa (the BRICS countries) to lead efforts in TB control.
Preparedness, Response, and Recovery Considerations for ...
Released: December 17, 2013
Although children represent about 25 percent of the U.S. population, current state and local disaster preparedness plans often do not include specific considerations for children and families. The preparedness and resilience of communities related to children requires a systems framework for disaster preparedness across traditional and non-traditional medical and public health stakeholders. The IOM Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop to discuss disaster preparedness, response, and recovery relative to the needs of children and families, including children with special health care needs.
Oversight and Review of Clinical Gene Transfer Protocols ...
Released: December 05, 2013
In the 1970s, scientists first developed methods for manipulating DNA – resulting in what is called recombinant DNA. One of the applications of these methods, known as gene transfer, is an experimental technique involving the insertion of new genetic material into a human subject. In response to concerns about gene transfer, NIH established in 1974 the Recombinant DNA Advisory Committee (RAC) to provide oversight and a public forum for discussion. Many have argued that today RAC review is redundant and unnecessary in its current form. NIH asked the IOM to form a committee to determine whether gene transfer research continues to raise concerns that warrant extra oversight by the RAC of individual clinical trial protocols involving gene transfer. The committee was also asked to recommend criteria to guide when the RAC should, if deemed necessary, review individual protocols.
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.