Closer Look
Finding a way to use digital biomarkers in clinical trials
Here's the hope: Digital biomarkers, defined as physiological or behavioral data captured by technologies like wrist-worn wearables, might one day speed treatments to market by accelerating clinical trials for drugs. That's still just a hope because digital biomarkers are time-consuming, expensive, and difficult to develop — just like the other rigorously validated measures drug companies use.
For larger companies like Regeneron, it's not as simple as adding a digital biomarker-delivered endpoint into a trial already in progress. But Regeneron is deploying wearable sensors to measure physical activity in a post-market trial of Dupixent for adults with asthma. "If you have a better way to measure something by default, we should utilize it," Regeneron's Rinol Alaj said at a conference on digital biomarkers hosted by the company this month. "It's just a matter of creating awareness, showing case studies, and sharing with the industry." STAT's Mario Aguilar has more from the meeting.
in the lab
Molecular signatures of PTSD appear in the blood
Post-traumatic stress disorder is a syndrome that travels throughout the body and the mind, but tracking its reach into physical and psychological conditions has been challenging. A new study in Cell Reports Medicine finds clues in the blood of active-duty soldiers and veterans deployed to Iraq and Afghanistan where they witnessed trauma. Their samples reveal molecules activated in inflammation, oxidative stress, metabolic dysregulation, and impaired formation of new blood vessels. Scientists think they may be involved in scenarios as varied as wound healing, cardiovascular problems, and mental distress.
The analysis revealed alterations in which genes that were activated and which proteins and metabolites were circulating, changes that correlated with the severity and duration of symptoms in the 340 veterans (300 males and 40 females) and 180 soldiers (159 males and 21 females) they studied. "PTSD is coming to be seen as a systemic disorder rather than as a purely psychological illness," the authors write.
public health
Tracking dengue in tropical U.S. territories, CDC urges vaccination where it's endemic
Dengue is one of the most common mosquito-transmitted viral diseases around the world, and cases are rising. It's endemic in some U.S. tropical territories: A CDC report tracking trends in American Samoa, Puerto Rico, and the U.S. Virgin Islands found more than 30,000 cases from 2010 through 2020, with cases highest in Puerto Rico but incidence highest in American Samoa.
Children and teens were disproportionately affected, but as STAT's Helen Branswell has reported, vaccination carries some risk. Giving the vaccine Dengvaxia is recommended for children 9 to 16 years old who have lab confirmation of previous dengue infection and live where dengue is endemic. That's because for those who haven't had dengue before, the vaccine raises the risk of severe dengue. "New dengue vaccines will likely expand the population groups eligible for vaccination and the impact of this intervention," the report concludes while recommending careful use of the current one.
In this week's episode of "First Opinion Podcast," Jennifer Lycette and host Torie Bosch discuss the potential for AI and ChatGPT in health care settings and what this technology could mean for patient and provider experiences in the future. Listen here.
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