Patient groups urge Congress to reauthorize Prescription Drug User Fee Act, improve clinical trial diversity

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Eighty-seven organizations representing patients with chronic and acute health conditions sent a letter to Congress urging them to improve the diversity of enrollment in clinical trials as part of this year’s Prescription Drug User Fee Act reauthorization. 

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I have spent over 20 years running a tumor imaging metrics core at an academic cancer center. In that time, I have watched clinical trial enrollment concentrate at a relatively small number of flagship academic institutions. Unfortunately, trials do not propagate well to the community sites where most patients prefer to receive care. The explanations usually offered for why this happens have never fully accounted for what I observed.
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Divarasib, a next-generation KRAS G12C inhibitor, lowered the risk of disease progression or death by 42% and the overall risk of death by 44% in people with previously treated KRAS G12C-mutated non-small cell lung cancer, according to the results from the phase III Krascendo 1 study. The therapy demonstrated the superior efficacy compared with current standard of care KRAS G12C inhibitors. 

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