CMS, FDA Recommend Important Changes to Data Collection

An opinion piece in JAMA has been released by the acting administrator of CMS and FDA commissioner that suggests amendments to trial design and data collection, and explains the requirement for collaboration across public and private sectors—all in an attempt to fortify the proof on which coverage and regulatory decisions are made.

The gradual and piecemeal manner in which information is gathered and maintained in disconnected databases has contributed to queries on whether FDA marketing clearance also means the product will be reimbursed. Shared resources are significant; however approval criteria would sustain to be distinct. Whereas, the FDA approval procedure finds substantial proof from at least one “well-conducted” clinical trial, CMS develops the standard for coverage as “reasonable and essential.”

The authors pointed that determining a product being established in the proposed population who will use it post launch is important, and they suggested engaging this population in early phases of a clinical trial. The authors also suggested the participation of health systems and health plans earlier in the procedure “to understand and deal the kinds of evidence required to incorporate the latest product into practice, place it on formulary or device inventory, and choose whether and how much to pay for its use, thereby facilitating execution and adoption.”

The CMS and FDA have established the following suggestions to improve on the existing practice of clinical evidence generation for researchers and institutions:
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1. Linking and connecting databases. Capitalizing on existing digital data is vital, and the authors suggest connecting data collected during healthcare delivery that is trapped in EHRs (electronic health records), insurance claims, and clinical registries.
2. Choosing the correct patient population. CMS and FDA would like to see more diversity among clinical trial enrollees, particularly for products that acquire biomarker-based accelerated approval.
3. Developing the public-private partnerships. Approaches like the Patient-Centered Outcomes Research Institute are perfect, the article stated, with broad stakeholder involvement.

These following amendments will permit both the CMS and FDA to measure more patient-centered health results and also pave the way for a more personalized approach to medicine.