Pfizer COVID-19 Vaccine Trial Diversity Slips As Enrollment Rises, Unlike Moderna
Trial diversity is among the issues that stakeholders worry could hinder vaccine uptake.
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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?
Oncology Center of Excellence Director Richard Pazdur asked whether the FDA should have more conversations with sponsors about site selection and percentages of US participants.
Acting FDA commissioner says there are a lot of strong forces in the research and pharma industries that could curb efforts to make pandemic-related clinical trial reforms permanent.