BioCentury
ARTICLE | Product Development

Stakeholders call for trial standardization as COVID-19 study influx burdens the system

BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.

April 24, 2020 8:45 PM UTC
Updated on Apr 24, 2020 at 8:48 PM UTC

The clinical trial infrastructure for COVID-19 is creating an unsustainable burden on regulators, physicians and patients. Changing the story will require centralized data collection, harmonization across study endpoints and implementation of master protocols, according to a team of expert stakeholders.

During a public webinar hosted by the Clinical Trials Transformation Initiative (CTTI) on Thursday, representatives from FDA, EMA, WHO and several biopharma companies outlined the problems COVID-19 has created in the clinical trial landscape and the best practices for accelerating clinical development. The CTTI is a public-private partnership between FDA and Duke University...