In a blog post for the Association of Clinical Research Professionals (ACRP), Bass, Berry & Sims attorney Clint Hermes discussed the experimental treatment options for COVID-19 in development during the COVID-19 pandemic. As Clint points out, vaccine trials and related treatments are “floating in and out of different pathways” of development, including clinical trials. Because of this fluid and ever-changing landscape it’s vital for clinical trial practitioners, especially those involved in regulatory affairs and those working in academic medical centers, to be at the very top of their game in terms of understanding current regulations and expectations, he says.
Clint will speak about this topic with fellow Bass, Berry & Sims attorney Nesrin Tift at a November 10 webinar titled “Research and Expanded Access in Pandemic Times.” Information about this webinar can be found on the ACRP website.
The full article, “Experimental COVID-19 Treatments Test the Boundaries of Expanded Access,” was published by ACRP on October 29 and is available online.