Sponsors (31)
Official title: To modernize clinical trials and remove barriers for participation in clinical trials, and for other purposes.
Introduced May 20, 2025 by Raul Ruiz · Last progress May 20, 2025
The bill lowers financial and logistical barriers and clarifies legal pathways to expand and diversify clinical‑trial participation—benefiting underrepresented patients and local research capacity—but raises fiscal costs, administrative complexity, privacy/conflict‑of‑interest risks, and potential enforcement gaps that could undermine equity and oversight.
Patients from underrepresented groups nationwide (racial/ethnic minorities, low‑income, rural residents, people with disabilities, and Medicare/Medicaid beneficiaries) will be more likely to enroll in clinical trials because the Act funds targeted outreach, multilingual materials, community partnerships, travel/meal reimbursements, provision of digital devices, cost‑sharing waivers, and tax and-li
Individuals participating in approved clinical trials will face lower direct costs because sponsors may subsidize cost‑sharing, out‑of‑pocket costs can be waived for Medicare/Medicaid beneficiaries, travel/meal/transportation can be reimbursed, and up to $2,000 per year of trial payments can be excluded from taxable income, reducing financial barriers to participation.
Sponsors, providers, and hospitals gain clearer legal protections and reduced fraud liability risk when facilitating or subsidizing trial participation, which lowers legal uncertainty and may encourage sponsor and provider support for recruitment and participant assistance.
Taxpayers and federal health programs could face meaningful increased spending or revenue loss from grant authorizations, subsidies, reimbursements, tax exclusions, and potentially greater utilization if trial participation rises—raising fiscal pressure and potential offsets to other programs.
Manufacturer or sponsor payments, device provision, and subsidized cost‑sharing could create real or perceived conflicts of interest that influence enrollment, trial conduct, or prescribing patterns, risking biased recruitment and undermining trust in results.
Preserving broad liability protections and creating safe harbors for sponsor support may weaken incentives and authorities to detect or pursue fraud, abuse, or improper inducements tied to trial recruitment, increasing risk of misuse of public funds and program abuse.
Based on analysis of 7 sections of legislative text.
Funds outreach to recruit underrepresented groups into clinical trials, allows certain patient payments and digital tools despite anti‑kickback rules, permits manufacturers to pay cost‑sharing with safeguards, and excludes up to $2,000/year of trial payments from taxable income.
Creates grant and contracting authority to fund community education, outreach, and recruitment that increase participation of underrepresented populations in drug, device, and vaccine clinical trials. Changes federal fraud statutes to permit certain patient-focused payments and the provision of digital tools that facilitate participation, allows manufacturers to pay patient cost‑sharing under safeguards, and excludes up to $2,000 per year of clinical trial payments from individual taxable income.