IOM Topic: Biomedical and Health Research

Roundtable on Translating Genomic-Based Research for Health

5/22/2012

The Institute of Medicine Roundtable on Translating Genomic-Based Research for Health brings together leaders from academia, industry, government, foundations and associations who have a mutual interest in addressing the issues surrounding the translation of genomic-based research. The mission of the Roundtable is to advance the field of genomics and improve the translation of research findings to health care, education, and policy.

2011 Annual Report

5/22/2012

2011 Annual Report

Evidence Communication Innovation Collaborative

5/22/2012

The Evidence Communication Innovation Collaborative explores strategies, obstacles, and feasibility for collaborative communication efforts to improve patient engagement in health care decision-making.

Clinical Effectiveness Research Innovation Collaborative

5/22/2012

An ad hoc convening activity to provide a venue for information exchange and knowledge sharing among researchers working to develop and apply innovative approaches to evidence generation.

Roundtable on Value & Science-Driven Health Care

5/22/2012

The IOM Roundtable on Value & Science-Driven Health Care convenes leadership from key healthcare sectors to catalyze the collaborative work needed to drive improvements in the effectiveness and efficiency of medical care, by transforming how evidence is developed and used in health care.

Reducing Tobacco-Related Cancer Incidence and Mortality

5/17/2012

NCPF Tobacco Workshop

Public Engagement on Facilitating Access to Antiviral Medications and Information in an Influenza Pandemic - Workshop Series Summary

5/17/2012

Influenza pandemics overwhelm health care systems with thousands or hundreds of thousands of sick patients, as well as those worried they may be sick. In order to ensure a successful response to the patient swell caused by a pandemic, robust planning is essential. Distribution and dispensing of antiviral medications will need to occur within a potentially limited timeframe, and persist over a period of time to treat multiple waves of the pandemic. In response to a request from the CDC, the IOM held a series of workshops that explored the public’s perception of potential alternative strategies for facilitating access to antiviral medications and treatment during an influenza pandemic.

Maximizing the Goals of the Cures Acceleration Network to Accelerate the Development of New Drugs and Diagnostics: A Workshop

5/16/2012

This public workshop will consider options and opportunities to maximize the usefulness and impact of the CAN program in order to advance translational sciences. In addition to providing suggestions to NCATS, the workshop is, in part, in response to Congressional interest in CAN expressed in the FY 2012 appropriations act conference report.

Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule

5/15/2012

The IOM will conduct an independent assessment surrounding the feasibility of studying health outcomes in children who were vaccinated according to the CDC recommended schedule and those who were not.

Review of the California Institute for Regenerative Medicine

5/10/2012

The California Institute for Regenerative Medicine (CIRM) has requested that the IOM provide an independent assessment of CIRM's programs, operations, strategies, and performance since its inception in 2005.

Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule May Meeting

5/9/2012

Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule May Meeting

2011 Annual Report

5/9/2012

Annual Report

Evidence for Clinical Utility of Molecular Diagnostics in Oncology: A Workshop

5/9/2012

The Roundtable on Translating Genomic-Based Research for Health will co-host a workshop with the Center for Medical Technology Policy to discuss research methodologies required to demonstrate and assess the clinical validity and clinical utility of molecular diagnostics for oncology.

The Rhoda and Bernard Sarnat International Prize in Mental Health

5/7/2012

The Rhoda and Bernard Sarnat International Prize in Mental Health is awarded annually to individuals, groups, or organizations in order to recognize outstanding achievement in improving mental health services, research, or public policy.

Meeting 3: Committee on Review of California Institute for Regenerative Medicine (CIRM)

5/1/2012

The committee will assess the organization’s initial processes, its programmatic and scientific scope, organizational and management systems, funding model, and intellectual property policies. The public meeting is intended to provide an opportunity for the committee to gather information regarding aspects of the study charge.

Creation of a Central Management Plan for Every New Drug Needed to Strengthen FDA's Oversight of Approved Drugs' Safety

5/1/2012

Although the approval of a new drug is based on evidence that its benefits outweigh its risks, the full range of a medication's effects may not become apparent until a product has been used by a larger, more diverse population over an extended period of time. Problems associated with the anti-diabetes drug Avandia, pain reliever Vioxx, and cholesterol-reducing drug Crestor illustrate the challenges and underscore the need for a more systematic and transparent process to collect, assess, and act on data about a medication's benefit-risk profile throughout its entire "life cycle" from approval until it is no longer marketed, says a new report by the Institute of Medicine.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

5/1/2012

Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time. The passage of the Food and Drug Administration Act in 2007 provides the Food and Drug Administration (FDA) with additional postmarketing regulatory tools to better protect the health of the public, including the authority to require manufacturers to continue studying drugs that are being marketed. The FDA asked the IOM to evaluate the scientific and ethical aspects of conducting safety studies for approved drugs. The IOM recommends implementing a life cycle approach to drug safety oversight that could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.

Air Force Health Study (Ranch Hand) Research Assets - Announcement of availability for analysis

4/30/2012

In 1979, the US Congress directed that epidemiologic study be conducted to evaluate the frequency and nature of adverse health effects that might be related to exposure to “Agent Orange” and other military herbicide used during the Vietnam Conflict. The effort—formally called the Air Force Health Study (AFHS) and informally refered to as the Ranch Hand Study—involved Operation Ranch Hand veterans and a comparison group of Air Force personnel who served in southeast Asia but who were not involved in herbicide spraying operations.

After the Study concluded, the Congress directed that its research assets be transferred to the custodianship of the Institute of Medicine (IOM). A later Public Law (110-389) instructed the Department of Veterans’ Affairs to work with the IOM to make the AFHS assets available to scientific investigators for scientifically peer reviewed pilot and other research studies.

Facing the Reality of Multidrug-Resistant Tuberculosis: Challenges and Potential Solutions in India

4/27/2012

Burden and profile of drug-resistant tuberculosis in India and globally; Preventing transmission of drug-resistant tuberculosis / infection control strategies

Facing the Reality of Drug-Resistant Tuberculosis: Challenges and Potential Solutions in India - Summary of a Joint Workshop by the Institute of Medicine, the Indian National Science Academy, and the Indian Council of Medical Research

4/27/2012

An estimated 8.8 million people fell ill with tuberculosis (TB) in 2010 and 1.4 million died from the disease. Although antibiotics to treat TB were developed in the 1950s and are effective against a large percentage of TB cases, resistance to these antibiotics has emerged over the years, resulting in the growing spread of multi-drug resistant (MDR) TB. The IOM held a workshop April 18-19, 2011, in New Delhi, India, in collaboration with the Indian National Science Academy and the Indian Council of Medical Research, to highlight key challenges to controlling the spread of drug-resistant strains of TB in India and to discuss strategies for advancing and integrating local and international efforts to prevent and treat drug-resistant TB.

Assessing the Economics of Genomic Medicine: A Workshop

4/26/2012

This workshop will assess the potential economic impact that the advent of genomic medicine may have on clinical practice and research. The workshop will feature presentations and discussions from an array of stakeholders which may include health economists, providers, payers, guideline developers, patients, and regulators. The goal of the workshop will be to advance discussions around the clinical implementation of genetic and genomic technologies by examining costs associated with the development and use of genetic and genomic information in the care of individual patients.

Informatics Needs and Challenges in Cancer Research: A Workshop

4/25/2012

The National Cancer Policy Forum will hold a public workshop on February 27th and 28th, 2012 to examine the informatics needs and challenges for 21st century biomedical research, with a focus on the broad spectrum of cancer research, ranging from basic discovery science to translational research, product development, clinical trials, comparative effectiveness, and health services research.

Studying the Safety of Approved Drugs: IOM Report Releases May 1

4/25/2012

Although drugs undergo safety tests prior to approval, sometimes harmful effects do not become apparent until a product has been on the market for a while and has been used by a larger, more diverse population.

Delivering Affordable Cancer Care in the 21st Century

4/24/2012

With the goal of ensuring that patients have access to high quality, affordable cancer care, the National Cancer Policy Forum will convene a public workshop, Delivering Affordable Cancer Care in the 21st Century, on October 8 and 9, 2012.

Safe and Effective Medicines for Children: Pediatric Studies Conducted Under BPCA and PREA

4/23/2012

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation’s children.

Genome-Based Diagnostics: Clarifying Pathways to Clinical Use - Workshop Report

4/13/2012

New technologies are improving our ability to provide personalized treatment catered to an individual patient. Based on findings from the sequencing of the human genome, genome-based diagnostic tests have the potential to direct therapeutic interventions, predict risk or onset of disease, or detect residual disease. However, because evidence is lacking to show that these tests lead to an improved outcome, adoption has been limited. On November 15, 2011, the IOM held a workshop to discuss the differences in evidence required for clinical use, regulatory oversight, guideline inclusion, coverage, and reimbursement of genome-based diagnostics with the goal of clarifying a pathway for using these tests in clinical settings.

Integrating Large-Scale Genomic Information into Clinical Practice - Workshop Summary

4/13/2012

As the technology and affordability of genomic sequencing continues to evolve and the clinical applications for genomics-based research increase, it is important to address how genomics data can best be integrated into the clinical setting. On July 19, 2011, the IOM’s Roundtable on Translating Genomic-Based Research for Health hosted a workshop to highlight and identify the challenges and opportunities in integrating large-scale genomic information into clinical practice. Challenges for realizing genomic medicine range from the analysis, interpretation, and delivery of genetic information to associated workforce, ethical, and legal issues.

Generating Evidence for Genomic Diagnostic Test Development – Workshop Summary

4/13/2012

Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person’s response to certain drugs, estimate the risk of developing Alzheimer’s disease, and make other predictions based on known links between genes and diseases. However, genetic tests have yet to become a routine part of medical care, in part because there is not enough evidence to show they help improve patients’ health. The IOM held a workshop to explore how researchers can gather better evidence more efficiently on the clinical utility of genetic tests.

Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development - Workshop Summary

4/13/2012

Despite the many basic research discoveries in genetics, relatively few gene-based treatments, drugs, or preventative measures have been developed. One way to bridge this gap may be for industry, academia, and government to develop partnerships that share resources while distributing risk. However, intellectual property protections and other barriers can inhibit collaborative efforts. The IOM held a workshop on July 22, 2010, to explore these issues and develop solutions.

Challenges and Opportunities in Using Residual Newborn Screening Samples for Translational Research - Workshop Summary

4/13/2012

Newborn screening samples are used to test more than 4 million infants each year for life-threatening diseases that are treatable if found at birth. These specimens also represent a potentially invaluable resource for public health and biomedical research. The IOM held a workshop to examine issues surrounding the use of blood samples for translational research.