Earlier this year, Food and Drug Administration Commissioner Robert M. Califf proposed something radical: that private health care insurance companies (payers) should participate in clinical research on FDA-approved drugs.
This challenges the prevailing convention that only drug developers conduct such studies — and it’s an idea worth considering. While there is no major precedent for payers to participate, the move could augment clinical evidence and enhance patient-centric care across various therapeutic areas, including in Alzheimer’s treatment.
Drawing from my experience in developing precision medicine protocols for biotech drugs, I am aware of the complexities in implementing these strategies into clinical development or post-approval settings. Nevertheless, navigating these challenges is essential — which is why Klaritos, where I am CEO, is building a precision medicine platform for conducting payer-participating trials on FDA-approved drugs. Despite extensive investments by biotech and pharma companies in clinical trials, unresolved questions about the efficacy or safety of numerous approved drugs persist. Bringing payers into clinical research could help solve these problems.
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