HHS, NIH Take Steps to Enhance Transparency, Public Access to Clinical Trial Results

November 24, 2014 | by

Last week, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII (Clinical Trial Databases) of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to ClinicalTrials.gov, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health. The NIH also announced a proposal to apply the proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that all NIH-funded clinical trials be registered in ClinicalTrials.gov and that summary results be posted to the database in a timely matter. Both documents are open for a 90-day public comment period, and comments will be taken into consideration before final regulations and a final NIH Policy are issued.

ClinicalTrials gov

Study: Why Cancer Incidence May Increase with Age

February 7, 2014 | by

The accumulation of age-associated changes in a biochemical process that helps control genes may be responsible for some of the increased risk of cancer seen in older people, according to a National Institutes of Health (NIH) study.

DNA methylation

2013: Terrible Year for Great Ideas in Biomedical Research

January 29, 2014 | by

A recent analysis shows that the National Institutes of Health (NIH) budget, adjusted for inflation, was $6 billion less in 2013 than it was ten years ago, and the number of research grants awarded by the NIH has fallen to the lowest level in 15 years.

Funding down

The NIH and NFL Tackle Concussion Research

January 27, 2014 | by

The NIH recently announced eight research projects to study traumatic brain injury, funded largely by a donation from the NFL.

NIH NFL brain injuries

What the U.S. Government Shutdown Means to Your Health

October 10, 2013 | by

The United States government shutdown has slowed or halted federal efforts to protect Americans’ health and safety. Now in its 9th day, the shutdown has impacted food safety efforts, flu programs and disease-tracking, scientific research, and the economic and social well-being of families, children, individuals and communities.

US is closed