New Group Will Promote Decentralized Clinical Trials

06Jun

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Several of the world’s healthcare, bioscience and pharmaceutical firms, including such global leaders as AstraZeneca, Pfizer and Biogen have joined together to accelerate the adoption of decentralized clinical trials and research.

In the planning stage before the coronavirus pandemic, the Decentralized Trials & Research Alliance (DTRA) formally announced its founding this month. With an initial membership of some 50 organizations, the alliance declared its mission to “make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research.”

Explained Amir Kalali, MD, co-convenor of DTRA, “The benefits of decentralized research methodologies have been apparent for some time, but adoption has been slow due to many factors including culture and the lack of a forum for stakeholders to collaborate.

“The COVID-19 pandemic has forced organizations to adopt decentralized methodologies which have the potential to broadly accelerate drug development.”

Decentralized trials, also (imprecisely) referred to as virtual trials, allow patients to participate without the need to regularly or ever visit a research site. Through telemedicine visits, remote monitoring, wearables and smartphones, researchers can often collect as much or more data in many cases, and often more reliable data, than by requiring in-person visits.

Several months ago we blogged about the increasing use of decentralized trials – those that are entirely remote and those that include occasional face-to-face visits. In that June post we noted that “prompted by the COVID-19 pandemic, and given the blessing of the FDA, broad acceptance of decentralized trials is becoming a reality.”

Speaking at the virtual BIO 2020 conference, panelists agreed that the foothold COVID gave to decentralized trials will continue to grow, in large part because of its patient benefits. With participants freed from having to travel to research sites, it opens opportunities to recruit underrepresented populations. One example, cited by a panelist, was the potential now to include autistic patients.

DTRA, in its founding announcement, said, “Inclusion of representative patient populations in clinical trials by race, age, and geographic location has long been an operational challenge. Decentralized approaches to conducting research facilitate participation by a more diverse patient population and could ease COVID-19-imposed difficulties for both patients and clinical investigators.”

Added Craig Lipset, DTRA co-convener, “Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives.”

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Healthcare

Jun 6, 2023

COVID Is Prompting Youthful Vapers to Quit

Healthcare

Jun 6, 2023

COVID Is Prompting Youthful Vapers to Quit

COVID-19 has had at least one positive effect on health: Vaping, the use of e-cigarettes, among teens and young adults has decreased markedly since the beginning of the pandemic.

A survey reported Dec. 3 on the JAMA Network Open says almost a third — 32.8% — of young adult users 13-24 that changed their e-cigarette use since the beginning of the COVID-19 pandemic quit vaping. Another 35.3% reduced their use of e-cigarettes. Not all e-cigarette users changed their smoking habit, but 56.4% of the survey participants did.

One of the two researchers, Bonnie Halpern-Felsher, a developmental psychologist and professor of pediatrics at Stanford University, told HealthDay, “One of the main reasons they quit is that they were worried about lung health, and we think that’s important, that they thought they could hurt their lungs.”

Vaping already was on the decline according to a CDC and FDA survey conducted just before the COVID shutdown in March. The report published in September found 20% of high school students and 5% of middle school students were vaping in early 2020, compared with 28% of high school students and 11% of middle school students in 2019.

The just published survey said who quit or decreased their use out of concern for their health accounted for 25% of the total. Because they were at home and their parents would know caused 15.2% to quit or cut back. Another 19.5% said it was because they couldn’t get the products. Almost a third (32.1%) said a combination of those factors were responsible.

There’s good reason for youthful vapers to quit. Research has revealed that 13-24 year-old cigarette and e-cigarette users were much more likely than non-smokers to be diagnosed with COVID-19. Dual-users who vaped and smoked cigarettes were 7 times more likely to get a COVID diagnosis. Those who vaped only were 5 times more likely.

The newest survey also found those adhering to the stay-at-home orders were 1.5 times more likely to have reduced or quit e-cigarettes, a consequence of access being limited, a lack of socializing with other users or worries about parents or a combination.

“In this study, sheltering-in-place policies that may have limited access to retail store purchases may have helped facilitate quitting or reduced use among both underage youth and young adults,” the researchers noted.

However, they also found that “that vape shops and online platforms are routinely selling to underage youth during this pandemic.”

Photo by Chiara Summer on Unsplash

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