Don’t expect population-specific quotas in the US Food and Drug Administration’s long-awaited guidance on diversity action plans for Phase III and pivotal trials.
US FDA Commissioner Robert Califf Says No Formulas For Trial Diversity
The FDA does not appear likely to provide a calculation for sponsors to show clinical trial diversity, but agency officials seem split on how tough to enforce the new regulations intended to ensure all groups are adequately represented.
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The FDA Commissioner nominee also commented on trial diversity, the role of public comment and expedited biosimilar reviews during his Senate confirmation hearing.
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Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."
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The Association of Clinical Research Organizations has awarded “seed funding” to seven US-based community clinical trial sites to demonstrate proof-of-concept projects aimed at increasing diversity in clinical trials.
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The US Health and Human Services Secretary nominee’s commitment should be a positive sign for those who want to ensure Americans can access adequate data on drugs in all populations that could use them.
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Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
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The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
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Companies have until 17 March to respond to an EU consultation on a new strategy that will seek to simplify the regulatory framework and make it easier for innovative small and medium-sized enterprises to “access the capital they need” to scale up in the bloc.