Week of July 18, 2022

This week we highlight continued investment in driving more diversity and better representation in clinical trials. We also look at the impact of decentralized technology on trial enrollments, a major whistleblower settlement and the approval of a COVID-19 vaccine manufactured using traditional methods. Finally, we examine how gastrointestinal diseases are having their moment on social media.

Clinical trial diversity continues to be a focus for the clinical trials industry as it strives to ensure that people of all backgrounds are fairly represented in testing. Absent social considerations, ensuring that an analyzed cohort is representative of the overall population is a key tenet in statistical analysis. In an effort to improve diversity, the industry group Pharmaceutical Research and Manufacturers of America has used $10 million to establish community-based clinical trial sites in order to grant underrepresented communities an opportunity to participate in clinical trials.

We continue to see evidence of interest in the decentralization of clinical trials that offers trial participants freedom from lab-based testing. While few clinical trials are fully decentralized, most clinical trials incorporate some sort of decentralized trial technology such as wearables or online portals. This is good news as a study from the American Cancer Society Cancer Action Network further confirms that participants are more likely to participate in clinical trials that incorporate decentralized trial technology.

Biotech company Biogen has agreed to pay $900 million to settle a whistleblower lawsuit alleging kickbacks dating prior to 2015 related to manipulating prices of multiple sclerosis prescription drugs. “This agreement in principle does not include any admission of liability and is subject to the negotiation of final settlement agreements and documents,” the company’s management said in an earnings release.

This week the Centers for Disease Control and Prevention approved a two-dose regimen of Novavax’s COVID-19 vaccine for use in adults, the first approved COVID-19 vaccine to utilize protein technology. This technology has been used in vaccines for over three decades and is currently used in vaccines for influenza, hepatitis and whooping cough. The new vaccine is expected to be available in the coming weeks.

Social media is helping to destigmatize diseases like Crohn’s and irritable bowel syndrome as influencers share their stories on Twitter, TikToc and other social media. Influencers and GI doctors hope that the spotlight will help patients become more comfortable discussing these issues and encourage them to seek treatment.

Source link