Although Alzheimer’s stakeholders are dismayed by the treatment access restrictions imposed by the Medicare national coverage determination last spring, the policy has also jumpstarted improvements in clinical trials for Alzheimer’s drugs in an important way, according to Global Alzheimer’s Platform Foundation president John Dwyer.
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 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Clinical trial draft guidance webpages are back online following a court order, but with new language disclaiming any information promoting gender ideology as "extremely inaccurate."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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As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
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While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
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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.