September 13, 2021
Why the Pandemic is a Crucible for Clinical Trial Innovation
Written by: Amy Ripston
September 13, 2021
Drug Discovery Trends
Neta Bendelac, Senior Director, Strategy, speaks with Drug Discovery Trends about COVID testing, and how clinical trials need to stay ahead of new mutations.
The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations.
To get a clearer sense of what the ramifications of this accelerated development will be for the industry at large, we spoke with Neta Bendelac, Sr. Director, Strategy at 4G Clinical.
Drug Discovery & Development: What impact has the pandemic had on trials for COVID-19 therapies?
Neta Bendelac: Speed was the most important factor for the early COVID-19 studies as many sponsors raced to get promising therapies and potential vaccines into the clinic. We all felt the urgency, all day, every day. It made sense for the FDA to stick to the gold standard of placebo trials so that the results would be clear.
Unfortunately, many of the therapies didn’t have matching placebos, so the studies needed to have both blinded and unblinded staff at the clinical sites. This added an element of complexity to maintaining the blind and protecting the integrity of the data.
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