Could The US FDA Set Clinical Trial Diversity Minimums?
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.
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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?
Data on minority groups were frequently underreported, and in many cases numbers have not improved with time, according to the study by Tufts CSDD.
The must-pass bill has many FDA policy ornaments hanging from it, but the version released by Democratic and Republican committee leadership has notable absences as well, including Cures 2.0.