Medicare Alzheimer’s Coverage Policy Advancing Clinical Trial Diversity Efforts
Medicare national coverage determination for Alzheimer’s drugs has been a ‘game changer’ in terms of motivating industry to boost diversity in clinical studies in the disease, trial expert says.
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The director of the US FDA’s Center for Drug Evaluation and Research acknowledged that the FDA cannot improve trial diversity alone.
Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.
Roche’s gantenerumab has failed to make the grade in its GRADUATE studies, leaving the field wide open for Eisai and Biogen’s lecanemab.