WASHINGTON — Federal laws that motivate or require drug and biologic developers to conduct pediatric studies have yielded beneficial information to guide the use of medications in children, says a new report by the Institute of Medicine. Still, studies involving children continue to be limited, especially in certain areas such as medications’ use in newborns and long-term safety and effectiveness in children. The report identifies ways that Congress and the U.S. Food and Drug Administration could further improve the utility of clinical information obtained from pediatric studies, including expanding innovative strategies to research drugs and biologics in children, using FDA’s authority to require long-term pediatric studies of possible safety risks, and giving FDA flexibility to impose sanctions for unreasonably delayed studies.
A new Institute of Medicine report details actions needed to help people with chronic diseases live healthier, more productive lives and reduce the toll of chronic illness on individuals and the nation.
WASHINGTON– Bruce B. Darling, currently vice president for laboratory management at the University of California, will soon join the National Academy of Sciences and National Research Council as executive officer. His transition from the university to NAS will occur over the next several months. He will succeed E. William Colglazier, who now serves as science and technology adviser at the U.S. Department of State. Read More.
WASHINGTON — A new data network that integrates emerging research on the molecular makeup of diseases with clinical data on individual patients could drive the development of a more accurate classification of disease and ultimately enhance diagnosis and treatment, says a new report from the National Research Council. The “new taxonomy” that emerges would define diseases by their underlying molecular causes and other factors in addition to their traditional physical signs and symptoms. The report adds that the new data network could also improve biomedical research by enabling scientists to access patients’ information during treatment while still protecting their rights. This would allow the marriage of molecular research and clinical data at the point of care, as opposed to research information continuing to reside primarily in academia.
WASHINGTON – The National Research Council today released the third edition of the Reference Manual on Scientific Evidence. Developed to guide judges as they encounter scientific evidence at trials, it replaces an edition published in 2000 and includes new chapters on areas such as neuroscience, mental health, and forensic science. The new manual was developed in collaboration with the Federal Judicial Center, which produced the previous editions, and was rigorously peer-reviewed in accordance with the procedures of the National Research Council.
NAS Members honored are:
National Medal of Science
Jacqueline K. Barton (NAS), California Institute of Technology
Ralph L. Brinster (NAS, IOM), University of Pennsylvania
Shu Chien (NAS, NAE, IOM, University of California, San Diego
Rudolf Jaenisch (NAS, IOM), Whitehead Institute MIT
Peter J. Stang (NAS),University of Utah
Richard A. Tapia (NAE), Rice University
Srinivasa S.R. Varadhan (NAS), New York University
National Medal of Technology and Innovation
Rakesh Agrawal (NAE), Purdue University
B. Jayant Baliga (NAE), North Carolina State University
Yvonne C. Brill (NAE), RCA Astro Electronics (retired)
Other winners of the National Medal of Technology and Innovation are C. Donald Bateman of Honeywell and Michael F. Tompsett of TheraManager
As of today all PDF versions of books published by the National Academies Press will be downloadable to anyone free of charge. This includes a current catalog of more than 4,000 books plus all future reports printed by NAP. “Our business model has evolved so that is now financially viable to put this content out to the entire world for free,” said NAP executive director Barbara Kline Pope. “This is a wonderful opportunity to make a positive impact by more effectively sharing our knowledge and analysis.”
A public workshop will be held to examine the perceived value of genetic and genomic technologies, both present and future, in clinical practice from different stakeholder perspectives.
This workshop will build on the concepts of clinical utility, personal utility, public utility, and economic value, and explore these different types of value through questions such as:
-How do different stakeholders define the value of genetic and genomic technologies?
-How do stakeholders evaluate the weight of one kind of value in relation to another?
-How do people assess relative values to make health care decisions?
-How do these types of value relate, or not relate, to the monetary cost of the technologies?
Presentations and discussions will explore the concept of value in regards to genomics and genetics, and how it affects the view of stakeholders and the way they make decisions about using these technologies. Stakeholders, including patients, payers, policy makers, and others will present their perspectives.