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