How Little Moderna Made Big Waves In Trial Diversity
Early on, the company committed to transparency while making sure its Phase III vaccine study enrolled a population reflective of the US as a whole. Moderna talks to Scrip about the experience.
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JAMA reports on the COVID-19 Prevention Network’s efforts. Also, Inhibikase said the US FDA lifted a hold on its drug for Parkinson’s disease, while Astellas Pharma said the agency lifted a clinical hold on its gene therapy for Pompe disease. And Trefoil, Theriva Biologics and Nektar initiated new trials.
Operational actions, organizational responses and clinical development model improvements led to a 26-month acceleration, on average, in a set of COVID-19 vaccine pivotal trials versus similarly sized pre-pandemic studies, with the database lock and analysis stage delivering dramatic gains, a study by IQVIA Institute indicates. Can these benefits be recapitulated across the portfolio in the post-pandemic era?
Company strategies at improving diversity, equity and inclusion both within their organizations and in the clinical trials they conduct have differed, but building trust is a common theme.