The Clinical Trial Modernization Act would allow sponsors to cover medical costs such as copays and non-medical costs including travel, lodging and childcare for clinical trial participants. The bill would provide digital health tools at no cost to enable remote participation. It would fund HHS grants for outreach to underrepresented communities and exempt up to $2,000 in trial-related financial support from taxation and safety-net eligibility calculations. A coalition of 131 healthcare organizations, including major patient and professional groups, supports the bill. Enrollment barriers cited include cost-sharing, travel burdens, and underrepresentation of rural, racial and ethnic minorities, older adults and low-income patients.
Specifically, the bill would allow sponsors to cover both medical (like copays) and non-medical costs (such as travel, lodging and childcare) related to clinical trials, and provide patients with digital health tools needed for remote participation at no cost. It would also support outreach to underrepresented communities through HHS grants and ensure that up to $2,000 in trial-related financial support is not taxed or counted against eligibility for safety net programs like Medicaid.
Costs are also a significant barrier for many patients, as there are often cost-sharing requirements in order to be covered for medical trials. In addition, patients sometimes have to travel so they can participate in clinical trials, which means they have to pay for transportation, lodging and meals. This is especially true when it comes to cancer-related clinical trials, as there are fewer locally available trials.
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