Four details:
1. CMS said approved studies must include a diverse group of patients representative of the national diagnosed population, but patient advocates told Bloomberg the agency doesn’t clarify how organizers can combat geographic, financial and safety barriers.
2. CMS previously responded to criticism from patient advocates by removing the requirement that approved clinical trials take place at hospital-based outpatient centers, according to the report. Those centers may be the only locations with the medical research teams needed to conduct the trials, however. Advocates say some minority and rural populations may not live near these sites or have the resources to travel.
3. The coverage plan also doesn’t push researchers to conduct preliminary safety studies for patients with Down syndrome, Bloomberg reported. Those studies are needed before those patients can be included in larger efficacy trials.
4. Reimbursements for the cost of travel, child care, and time taken off from work can help attract a more diverse group of trial participants, Yale University National Clinician Scholars Program fellow Reshma Ramachandran told Bloomberg.
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