viernes, 5 de diciembre de 2014

DLPSS|HEALTHCARE NEWS|December 04, 2014

DLPSS|HEALTHCARE NEWS|December 04, 2014

CDC. Centers for Disease Control and Prevention. CDC 24/7: Saving Lives. Protecting People.

A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services


December 04, 2014



News Highlights


  • Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments
  • USPSTF: Routine Vitamin D Screening Unsupported
  • Ebola Vaccine Seems Safe in First-stage Testing
  • COLA White Paper Urges New Focus on Office Lab Protocols
  • Sophisticated HIV Diagnostics Adapted for Remote Areas
  • 15-Minute Ebola Test to Undergo Trials in Guinea
  • HDL Functionality Inversely Linked With CVD Outcomes: Dallas Heart Study
  • NIH Scientists Determine How Environment Contributes to Several Human Diseases
  • Scientists Make Enzymes From Scratch
  • HIV Evolving 'into milder form'
  • Only 3 in 10 Americans with HIV Have Virus in Check
  • IDC's Top 10 Health IT Predictions for 2015
  • Most Patients Willing to Share Health Data with Researchers, Employers


View Previous Issues - Healthcare News Archive


Leading News



Framework for Regulatory Oversight of Laboratory Developed Tests; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” The purpose of this workshop is to discuss FDA's proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs)  referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity for public comment. Dates and Times: The 2-day public workshop will be held on January 8, 2015, from 8:30 a.m. to 5:30 p.m. and on January 9, 2015 from 8:30 a.m. to 5:30 p.m.
Location: The public workshop will be held at the Natcher Center at the National Institutes of Health Campus, 9000 Rockville Pike, Bldg. 45, Auditorium, Bethesda, MD 20814.
USPSTF: Routine Vitamin D Screening Unsupported
There is not enough evidence that vitamin D screening is beneficial in routine practice and therefore it can't be recommended, according to the U.S. Preventive Services Task Force. Following an extensive literature review, the group said the exact threshold that defines vitamin D deficiency isn't well established, and the association between vitamin D status and health outcomes isn't clear, according to Michael LeFevre, MD, MSPH, of the University of Missouri, and colleagues. They published their recommendations online in the Annals of Internal Medicine. It applies to asymptomatic, community-dwelling, nonpregnant adults ages 18 years and older. On the other hand, it does not apply to patients with certain conditions such as bone, endocrine, and autoimmune disorders, "because vitamin D testing in these populations could be considered management of a condition rather than general screening."
Low Vitamin D Tied to Higher Death Risk
Many observational studies suggest that low vitamin D levels are associated with an increased risk for disease, but it is not clear if low vitamin D is a cause or an effect of poor health. Now a new study, using a technique called Mendelian randomization, provides persuasive evidence that low serum vitamin D itself increases the risk of death. For the study, published in BMJ, researchers used data from Danish government health records on 95,766 subjects. All were tested for a genetic variant that reduces their vitamin D levels, and 35,334 also had their vitamin D serum levels measured. There were 10,349 deaths over the course of the study, from 1981 to 2013. By studying two large populations, of which one has the genetic variant for low vitamin D and the other does not, researchers were able to virtually eliminate the impact of confounding factors like other diseases, habits and behaviors that might be contributing to poor health. These traits would be evenly distributed in the populations studied, leaving only the genetic difference between them.
Ebola Vaccine Seems Safe in First-stage Testing
An experimental Ebola vaccine appears safe and triggered signs of immune protection in the first 20 volunteers to test it, U.S. researchers reported Wednesday. The vaccine is designed to spur the immune system's production of anti-Ebola antibodies, and people developed them within four weeks of getting the shots at the National Institutes of Health. Half of the test group received a higher-dose shot, and those people produced more antibodies, said the study published in the New England Journal of Medicine. Some people also developed a different set of virus-fighting immune cells, named T cells, the study found.

Laboratory Testing / Diagnostics


COLA White Paper Urges New Focus on Office Lab Protocols
Family physicians may be surprised to learn that laboratory testing is the single highest-volume medical activity performed in the United States. In fact, according to authors of a white paper recently released by the laboratory accreditation organization known as COLA, (www.cola.org) some 13 billion tests are performed every year. But arguably, the most important statistic reflects what happens after those tests are performed. "About two-thirds of clinical decisions are based on laboratory test information," said the authors of the COLA paper, which is titled "Integrating Laboratories into the PCMH Model of Health Care Delivery." And then there's this to consider: "Lab testing is often directive of more costly downstream care," they said. That's why COLA leaders -- using the white paper as a communication vehicle -- are encouraging physicians and their laboratory personnel to establish practices that align with patient-centered medical home (PCMH) standards in three key areas:
  • controlling test utilization;
  • identifying risks and controls for all three phases of laboratory testing (pre-analytic, analytic and post-analytic); and
  • coordinating lab results among primary care physicians, other health care professionals and patients in the PCMH neighborhood.
Sophisticated HIV Diagnostics Adapted for Remote Areas
Diagnosing HIV and other infectious diseases presents unique challenges in remote locations that lack electric power, refrigeration, and appropriately trained health care staff. To address these issues, researchers funded by the National Institutes of Health have developed a low-cost, electricity-free device capable of detecting the DNA of infectious pathogens, including HIV-1. The device uses a small scale chemical reaction, rather than electric power, to provide the heat needed to amplify and detect the DNA or RNA of pathogens present in blood samples obtained from potentially infected individuals. “This highly creative technical solution brings sophisticated molecular diagnostics to underserved populations and represents a potentially groundbreaking advance in global health care for HIV as well as tuberculosis and malaria, which remain significant health challenges in many remote areas,” said Roderic Pettigrew, Ph.D., M.D., director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at NIH.
15-Minute Ebola Test to Undergo Trials in Guinea
A rapid diagnostic test for the Ebola virus is about to be trialed at the Ebola treatment center in Conakry, Guinea, The Wellcome Trust announced. The new test, which can analyze blood or saliva samples, can make a diagnosis within just 15 minutes. Current technology can take anywhere from a couple of hours to four days to yield an accurate result. The trial will use a “mobile suitcase laboratory” which is solar-powered for use in remote locations with limited power.
Brain Insulin Resistance Marker May Diagnose Alzheimer's
A neuronal protein that is defective in Alzheimer's disease (AD) and detectable in blood may be able to predict the disease up to 10 years before clinical symptoms appear, early research hints. The protein, insulin receptor substrate-1 (IRS-1), plays a key role in insulin signaling in the brain. Brain insulin resistance occurs in AD even in the absence of peripheral insulin resistance, but until now, no brain biomarker of brain insulin resistance has been discovered. The new research suggests that dysfunctionally phosphorylated IRS-1 in neural-derived blood exosomes may be a specific biomarker of brain insulin resistance in AD. Dimitrios Kapogiannis, PhD, from the National Institute on Aging in Baltimore, Maryland, reported the findings at the Society for Neuroscience 2014 Annual Meeting.
Type 1 Diabetes Could be Diagnosed With Simple Breath Test, Says Oxford University
A breath test which will tell parents instantly if their child has Type 1 diabetes has been developed by Oxford University. The test picks up levels of acetone in the breath and prevents the need for an invasive and upsetting blood test. And it could mean that diabetes could be diagnosed within minutes rather than days. The test works by detecting the harmful chemicals called ‘ketones’ which accumulate in the body when insulin levels are low. “Our results have shown that it is realistically possible to use measurements of breath acetone to estimate blood ketones,” said co-author Professor Gus Hancock. “Currently testing for diabetes requires a blood test which can be traumatic for children.
High-tech Analysis of Genetic Data may Yield New Test for Endometriosis
Using sophisticated computer-based technology to analyze genetic data obtained from uterine tissue, researchers have identified patterns of genetic activity that can be used to diagnose endometriosis, an often-painful condition that occurs when tissue that normally lines the inside of the uterus grows outside the uterus. The prototype diagnostic method, developed with funding from the National Institutes of Health, can not only distinguish endometriosis from other disorders of the uterus, but can also identify the severity of the disease. The finding is the first step toward the eventual development of a test to diagnose endometriosis that wouldn’t require surgery. Currently, a surgical procedure known as laparoscopy is the only definitive way to diagnose and stage endometriosis that occurs on the pelvic lining and organs. A study by NIH researchers estimated that as many as 11 percent of women have endometriosis.
Innovative Microfluidic Chip Cuts Blood Amount Taken for Tests by Half
Researchers at IIT-B have now designed a microfluidic chip for blood separation that can function with a very little blood. Importantly, the microfluidic chip offers almost 100% efficiency in the separation. Usually, microfluidic chips either separate blood by force (electric, gravitational, magnetic) or rely on a passive separation. Simply put, the bifurcation law states that if a blood channel bifurcates, the red blood cells will move where there is a higher flow rate. The challenge in using the bifurcation law is that if one designs larger channels, the law does not work, and if one designs smaller channels of micrometer dimensions, there are problems of clogging. Amit Agrawal, department of mechanical engineering, IIT-B, explains that the new innovation has a channel size of around 0.1mm (100 micrometers) instead of a few micrometres; yet the bifurcation law works at such large dimensions. The microfluidic chip has a T-channel. When the blood is poured at one end of T-channel the blood flows normally till it encounters a split. "Red blood corpuscles continue along the straight channel with larger dimensions, whereas the plasma prefers to move through the perpendicular channel with smaller dimensions," says Agrawal.
Oncascan Developing UVA Technology to Reduce Number of Cancer Biopsies
Leveraging technology from the University of Bradford, a UK firm is developing a blood-based screening test for cancer that could reduce the number of unnecessary biopsies and other procedures. Called the Lymphocyte Genome Sensitivity Test, the technology uses UVA light to differentiate patients who have cancer from those who don't based on their DNA. If successful, though, Oncascan officials believe it could significantly reduce the number of biopsies and other procedures performed on patients who may be suspected of having certain types of cancer, but who later are found to be healthy.
AdvanDx Receives FDA Clearance for MRSA Assay
Molecular diagnostics firm AdvanDx announced that it has received 510(k) clearance from the US Food and Drug Administration for its mecA XpressFISH assay for the rapid detection of methicillin-resistant and methicillin-susceptible Staphylococcus aureus. The test provides results directly from blood culture samples in about an hour, the firm said, compared to 48 to 72 hours for conventional laboratory detection methods.
Controversial DNA Test Comes to UK
A personal DNA test that has sparked controversy in the US has launched in the UK. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) says the 23andMe spit test, which is designed to give details about a person's health risks based on their DNA, can be used with caution. But critics say it may not be accurate enough to base health decisions on. The company, California-based 23andMe, stands by its test. Backed by Google, the firm offered US customers details of health risks based on gene variants they carry. But in November 2013, the US Food and Drug Administration (FDA) banned the company from marketing its service in the US, claiming 23andMe had failed to provide adequate information to support the claims it made about results. A month later, the company stopped offering genetic tests related to health.
Undercover Assessment of Five Commercial NIPT Labs Points to Need for Better Quality Control
Results from an undercover performance test of five commercial noninvasive prenatal testing laboratories suggest a need for better quality standards, as three of the labs reported normal results in samples from women who were not even pregnant. The assessment, which involved just two samples and was conducted by Tamara Takoudes and Benjamin Hamar, maternal-fetal medicine specialists based in Massachusetts, was reported in a Letter to the Editor in Ultrasound in Obstetrics & Gynecology. One of the commercial testing labs, Ariosa Diagnostics, provided financial support for the study but its laboratory was not informed about the samples it received. All NIPT relies on the presence of cell-free fetal DNA in the mother's blood, though companies differ in how they measure and analyze the DNA to find chromosomal abnormalities, such as trisomies or microdeletions.

Research and Development



HDL Functionality Inversely Linked With CVD Outcomes: Dallas Heart Study
Cholesterol-efflux capacity, which is a marker of HDL function that measures reverse cholesterol transport, is inversely associated with incident atherosclerotic cardiovascular disease in a large population of patients healthy at baseline. The findings, say researchers, support "retiring" the HDL cholesterol hypothesis—the idea of simply raising HDL cholesterol to reduce the risk of cardiovascular disease—and instead should shift the focus to measures of HDL functionality. In studies, including their own, Rohatgi said that HDL-cholesterol levels are not reflective of HDL functionality. One of the key functions of HDL cholesterol is the cholesterol-efflux pathway, which is the pathway where cholesterol is removed from macrophages within the arterial walls back into the bloodstream and out to the liver. As one of the key functions of HDL, their hypothesis was that if they could measure HDL-cholesterol–efflux capacity, they'd have a better handle on the role of HDL in atherosclerosis.
NIH Scientists Determine How Environment Contributes to Several Human Diseases
Using a new imaging technique, National Institutes of Health researchers have found that the biological machinery that builds DNA can insert molecules into the DNA strand that are damaged as a result of environmental exposures. These damaged molecules trigger cell death that produces some human diseases, according to the researchers. The work, appearing online Nov. 17 in the journal Nature, provides a possible explanation for how one type of DNA damage may lead to cancer, diabetes, hypertension, cardiovascular and lung disease, and Alzheimer’s disease.  Time-lapse crystallography was used by National Institute of Environmental Health Sciences (NIEHS) researchers to determine that DNA polymerase, the enzyme responsible for assembling the nucleotides or building blocks of DNA, incorporates nucleotides with a specific kind of damage into the DNA strand. Time-lapse crystallography is a technique that takes snapshots of biochemical reactions occurring in cells.
Scientists Make Enzymes From Scratch
Experts say they have achieved a scientific milestone - creating enzymes out of artificial genetic material that they made in their lab. The synthetic enzymes functioned just as well as real ones. The work, in Nature journal, not only provides clues to the building blocks of life but also points to a new way to make therapeutic drugs for humans. The UK Medical Research Council team now hopes to make more complex structures that rival nature.
Scientists Substitute Mice for Humans, but New Research Shows Just how Similar We Are
New research aims to figure out just how much we have in common with mice -- genetically speaking. When it comes to research about mammals, mice are the ultimate model. They're cheap to breed and keep in the lab and don't have the same handling difficulties -- and ethical concerns -- as non-human primates such as chimps. But just how much can a study that uses mice say about how the human body works? A whole host of papers published recently in Nature (as well as several other journals) show just how much we still have to learn about our favorite lab subjects. In general, the researchers found, the systems that control gene activity are largely the same between mice and men. But the places where genes differ may help scientists explain the limitations of some studies that use mice.
Team Sequences Mosquito Genomes to Better Understand Malaria Parasite Transmission
An international team has sequenced the genomes of mosquitoes from more than a dozen global Anopheles species in search of genetic features that explain differences in the insects' ability to transmit malaria-causing Plasmodium parasites. As they reported online recently in Science, researchers from Notre Dame, the Broad Institute, and elsewhere did genome and transcriptome sequencing on 16 Anopheles species from sites in Africa, Asia, Europe, and South/Central America. Compared to the fruit fly genome, the mosquito sequences seemed to lose and gain genes quite quickly, the team reported. They also tended to show rearrangements affecting the X chromosome and the loss of intronic sequences separating protein-coding portions of genes.
Strict Monitoring of Lithium Levels Urged
Plasma levels of lithium above the advised range are associated with a transient reduction in kidney function, research shows. But Emma Kirkham (University of East Anglia, Norwich, UK) and co-researchers note that the cumulative effects of multiple exposures are not clear. “[A]s such we suggest that lithium level monitoring should be undertaken at least every 3 months, in line with current UK guidelines, and not be reduced further until the impact of more than one exposure to these lithium levels has been fully established”, they write in BMJ Open. However, they note that patients are often not monitored as per the guidelines. Their study included 699 patients identified in a countywide database. The patients were aged between 18 and 96 years, with around half being older than 60 years, and about 60% were women. The cohort reflects real-life practice and is representative of other lithium-taking populations, says the team.

Public Health and Patient Safety



HIV Evolving 'into milder form'
HIV is evolving to become less deadly and less infectious, according to a major scientific study. The team at the University of Oxford shows the virus is being "watered down" as it adapts to our immune systems. It said it was taking longer for HIV infection to cause Aids and that the changes in the virus may help efforts to contain the pandemic. Some virologists suggest the virus may eventually become "almost harmless" as it continues to evolve. More than 35 million people around the world are infected with HIV and inside their bodies a devastating battle takes place between the immune system and the virus.
Only 3 in 10 Americans With HIV Have Virus in Check
Just 30 percent of Americans with HIV had the virus under control in 2011, and approximately two-thirds of those whose virus was out of control had been diagnosed but were no longer in care, according to a new Vital Signs report published by the Centers for Disease Control and Prevention.  The new study underscores the importance of making sure people with HIV receive ongoing care, treatment, and other information and tools that help prevent transmission to others, as well as the need to reach more people with HIV testing.  Among those whose infection was not under control, more than three times the proportion (66 percent) were no longer in care as had never been diagnosed (20 percent). The HIV epidemic continues to threaten the health and well-being of many Americans – with more than one million people living with the disease in the U.S. and 50,000 new infections each year.
Check Hep C Program Effective in Identifying HCV in New York
The Check Hep C program, a community-based initiative in New York that focuses on finding and testing individuals with hepatitis C virus infection in high-risk populations, was effective in increasing diagnostic testing and screening of individuals and connecting them with proper services, according to data presented at The Liver Meeting. “The primary success of the Check Hep C Program model was its effectiveness in identifying, diagnosing and linking high-risk hepatitis C infected persons to care,” researcher Mary M. Ford, of the New York City Department of Health and Mental Hygiene, told Healio.com/Hepatology. “With new HCV medications showing high cure rates and more tolerable side effects, there is an added imperative to diagnose HCV-infected persons and link them to care and treatment.” The program, which formed after the CDC recommended HCV testing, funded eight organizations from 12 community clinical sites, including federally qualified health centers, syringe exchange programs and these combined facilities, to provide testing in high-risk neighborhoods. The testing procedure consisted of “targeted outreach, point of care rapid antibody testing and, after a positive antibody test, an immediate blood draw for RNA testing,” according to the research.
Bases Covered: U.S. and Africa Need Ebola-Ready Hospitals, Experts Say
The United States must establish a network of Ebola-qualified hospitals both at home and in the West African countries fighting the growing epidemic, experts said. They said the U.S. is in danger so long as the epidemic continues in Liberia, Sierra Leone and Guinea and added that without long-term investments both there and at home, other unexpected infections will threaten. “There is an urgent need to reinforce basic public health systems in countries, such as those in West Africa, where disease threats can quickly arise and ultimately threaten the health of Americans,” Centers for Disease Control and Prevention director Dr. Thomas Frieden told a hearing of the House oversight subcommittee. Had such a system been in place in Sierra Leone, Liberia and Guinea, there wouldn’t be an epidemic of Ebola there now, Frieden said.
'Back boost' Could Help Future-proof Flu Vaccines
An international team of scientists has found it may be possible to make seasonal flu vaccines more effective by using an idea known as "back boost" and pre-empting flu virus evolution. In a study published in the journal Science, the University of Cambridge-led team said their finding should enable people to be immunized against future likely flu strains as well as ones currently circulating. Using a new computer-based method they created so-called "antibody landscapes" showing in detail how the immune system responds to pathogens like flu that evolve and re-infect us. Analyzing these, the scientists found that when flu re-infects, the immune system responds not just to the infecting strain, but also to all the strains it has encountered in the past -- a phenomenon the researchers termed "back-boost". This suggests it makes more sense to pre-emptively vaccinate against likely future flu strains than to use a strain already circulating in the human population, the scientists said.
FDA Allows Unapproved Blood Transfusion System for Ebola Treatments
The U.S. Food and Drug Administration will allow an unapproved blood-transfusion system to be made available in an effort to increase the availability of plasma from Ebola survivors to treat newly infected patients. California-based Cerus Corp. said the FDA has approved a request submitted in October to make its Intercept Blood System for plasma available for use under the agency's investigational device exemption. Investigational device exemptions allow for an unapproved device to be used in a clinical study for the purpose of collecting data on its effectiveness and safety. Under the exemption, the company said it will conduct a trial of its device in collaboration with researchers from Emory University Hospital in Atlanta, the University of Nebraska Medical Center in Omaha, the American Red Cross and America's Blood Centers.

Health IT



IDC's Top 10 Health IT Predictions for 2015
What analyst firm IDC and others call "third platform" technologies are poised to gain purchase in healthcare during 2015. In the year ahead hospitals will – and should – make more advanced use of these technologies, which include mobile tools, social channels, data analytics and the cloud, according to a recent report from IDC Health Insights. With healthcare costs unsustainable, but these new technologies now ubiquitous, IDC officials say hospital CIOs will increasingly be turning to new tools – especially as consumers expect healthcare to be as responsive to their wants and needs as other industries. Meanwhile, cybersecurity concerns, care coordination and patient engagement will continue to be top concerns, spurring new approaches to IT as hospitals develop increasingly sophisticated digital strategies to improve care quality, broaden access and drive efficiency.
Indeed, "operational inefficiency will become critical at 25 percent of hospitals," according to IDC Health Insights, leading to many of those hospitals drawing up new plans for their IT deployments – requiring budgetary increases.
Most Patients Willing to Share Health Data with Researchers, Employers
A majority of patients would be willing to share their healthcare information with researchers, employers, health plans, and their doctors, according to a Truven Health Analytics-NPR Health Poll. More than 3,000 people responded to the survey, which included questions on information sharing, electronic medical records and privacy concerns. More than two-thirds or 68 percent of the respondents said they would be OK with sharing health information anonymously with researchers. According to the survey's author, that number increases with level of education and income. Millennials, those 35 and younger, were the most likely to be willing to share information anonymously at about 70 percent.
Hospitals Embrace Social Media, But Have yet to Realize its Full Benefits
The use of social media among U.S. hospitals is greater than previously thought, although its impact on patients and populations remains unknown, according to new research published in the Journal of Medical Internet Research. Researchers, led by Heather M. Griffis, Ph.D., of the Penn Social Media and Health Innovation Lab, University of Pennsylvania in Philadelphia, reviewed hospital-related activity on four social media platforms: Facebook, Twitter, Yelp and Foursquare. Hospitals that reported complete data for the Centers for Medicare & Medicaid Services Hospital Consumer Assessment of Healthcare Providers and Systems survey and the American Hospital Hospital's annual survey were included in the assessment. The research team estimated the use of social media based on specific user activity, such as the number of Facebook likes and Twitter followers.
MEDTECH Legislation Limits Regulation of EHRs, Decision Support
Forthcoming legislation drafted by Sens. Orrin Hatch (R-Utah) and Michael Bennett (D-Colo.) looks to exempt electronic health records and clinical decision support software from oversight by the U.S. Food and Drug Administration. The legislation—the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act—outlines five areas of the Federal Food, Drug, and Cosmetic Act, in all, to be amended.
8 Lessons Learned From Retail Breaches
Although most healthcare organizations don’t have a drive-through or Black Friday sales, they are responsible for managing sensitive data and can gain valuable insights from these retail breaches to better protect their patients and employees:
1. Where there is data there is risk.
2. External threats are increasing in importance
3. Cybercriminals are cutting out the middleman
4. New, large-scale attacks are replacing older methods. 
5. Criminals are finding multiple uses for stolen data.
6. To some degree, data breaches affect consumer confidence.
7. Turn the negative into a positive
8. Realize the inevitability of data breaches—and act accordingly.
Health IT Jobs Remain in High Demand
The number of jobs within the health IT space is growing, according to a report from HealtheCareers Network. Although the number of jobs posted in the third quarter declined by 4 percent from the second quarter, health IT was still up by 5 percent over the year. One percent of all healthcare job posts were health IT. The biggest growth area in health IT is predictive analytics, the report said, citing data from San Francisco digital health incubator Rock Health, which earlier this year noted that $1.9 billion of venture capital was invested into the predictive analytics.

Other News



Drug Trial Results Can’t Be Hidden Under Proposed Rules
Pharmaceutical companies, medical device makers and academic medical centers would no longer be able to withhold the results of clinical trials under rules proposed by the U.S. Department of Health and Human Services. While millions of Americans participate in trials of experimental drugs and devices to help find new treatments for themselves and others, the findings often aren’t made public, said Harlan Krumholz, a cardiologist and health policy professor Yale University in New Haven, Connecticut, and head of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation. Under the proposed regulations, any researcher getting funding from the U.S. National Institutes of Health would have to make their clinical trial results available on clinicaltrials.gov, an online database of experiments. Better access to study findings will help scientists focus on the most important research, reduce duplicative efforts, streamline the development of new therapies and help identify products that are unsafe or ineffective, Margaret Hamburg, Food and Drug Administration commissioner, said in a statement. It would also make sure the efforts of study volunteers are put to the best use possible, she said.

Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.
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