Tag Archives: clinical trials

Is your research a clinical trial? The answer may surprise you!

Background In October 2014, the National Institutes of Health (NIH) announced a change in its definition of a clinical trial, to take effect in January 2015. The new definition, which applies only to NIH-funded clinical trials, reads: “A research study in which one or more human subjects are prospectively assigned to one or more interventions… Read More »

FASEB Responds to NIH’s Call for Information on Age Inclusion in Clinical Research

The National Institutes of Health (NIH) on April 26 published a Request for Information (RFI) inviting comments on “the appropriate inclusion of pediatric and older populations in research studies involving human subjects.” Responses are due June 30. The RFI provides an opportunity for the scientific community and the public to express their views, while feedback… Read More »

NIH releases strategies for communicating research

The National Institutes of Health (NIH) released a list of strategies to help scientists make their research more accessible to the broader public. The guidelines, which include tips for researchers, educators, journalists, and other health professionals on writing about topics such as data outcomes, clinical trials, and studies with animal models, were compiled from advice… Read More »

FASEB questions utility of FDA pilot program

In response to a request from the Food and Drug Administration (FDA), the Federation of American Societies for Experimental Biology (FASEB) submitted comments questioning the usefulness of the pilot Clinical Outcome Assessment Compendium (COAC) on March 2. Intended to provide clarity to researchers designing clinical trials or developing new drugs, the COAC combines metrics for… Read More »