Survey says: Companies seek regulatory flexibility as COVID-19 makes clinical disruptions the new norm
A BioCentury/BIO joint survey finds COVID-19 has forced many companies to modify their clinical trials
COVID-19 is no longer an approaching threat to clinical trials; now the concern for biotechs is how to manage their trials through the crisis. A joint survey from BioCentury and BIO finds on-the-fly protocol amendments are fast becoming a necessity, and companies want assurance regulators will be flexible with the resulting datasets.
Over three quarters of the 99 survey respondents said their ability to start new trials or to continue active trials has been hindered by the coronavirus outbreak (see Figure: “COVID-19: Clinical Trial Disruptions Become the Norm”). The survey was conducted from March 16-19, and only full responses were included in the statistics.
The concern is accelerating; at the start of the month a BioCentury survey found under 20% of companies considered a clinical trial delay very likely. The remainder were split with 37% thinking a delay unlikely, and 44% responding