GPP3: New guidelines for publishing company-sponsored medical research

Pellet of Lymphocyte Cells Created in the Centrifuge

Companies that sponsor medical research should pay attention to an updated guideline that was recently released. The document, Good Publication Practice for Communicating Company-Sponsored Medical Research“, more commonly known as GPP3, is the third iteration of the guideline, which goes back to 2003.

The guideline covers all types of documents published in peer-reviewed journals (original research articles, short reports, reviews, letters to the editor) and presentations at scientific congresses and meetings (oral presentations, posters, abstracts).
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How drug and device companies should distribute scientific literature about unapproved uses

The US Food and Drug Administration (FDA) provides guidance to pharmaceutical and medical device manufacturers about distributing information on unapproved uses of their products. In 2009, the FDA released what is commonly referred to as “Good Reprint Practices.“* The FDA recognized that off-label or unapproved uses could be important to the standard of clinical care and to health care providers knowledge.

The guidelines were meant to outline how this information should be disseminated, through what types of publications, and how the information should be qualified. The ultimate goal was to allow companies to share scientific research about unapproved uses without promoting these uses. Continue reading How drug and device companies should distribute scientific literature about unapproved uses

Traumatic Brain Injury: A serious and underdiagnosed condition

I’m awoken in the middle of the night to my husband mumbling gibberish. During the day, he can’t recall words, such as magazine, in normal conversation. He has difficulty concentrating when reading dialogue. He loses his balance on a casual walk around our block.

You may be thinking that my husband is elderly or afflicted with dementia, but you’d be wrong. He’s a healthy guy in his late 20s. His symptoms are the result of a severe brain injury he sustained. For several months after his injury in 2009, I witnessed the life-altering effects that a brain injury can have and the frustration that my husband experienced dealing with his new condition.

In honor of Brain Injury Awareness Month, I wanted to provide information about monitoring and diagnosing brain injury because the outcome of a person who has sustained a brain injury depends on a quick and accurate diagnosis. Continue reading Traumatic Brain Injury: A serious and underdiagnosed condition