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Mandating Diversity and Reducing Burden in NIH-Funded Clinical Trials.

This Act requires NIH-funded clinical trials to set measurable goals for recruiting participants that reflect the racial, ethnic, age, and sex diversity of the patient population, ensuring that new treatments are safe and effective for all demographic groups. It also mandates the implementation of less burdensome follow-up options for participants, such as virtual or home visits, and requires a study on improving compensation for time and out-of-pocket expenses.
Key points
Clinical trials must establish clear recruitment goals to reflect the race, ethnicity, age, and sex diversity of the patient population being studied.
Research organizations must offer less burdensome follow-up options for participants, including telemedicine, home visits, or use of wearable technology.
The NIH will study modernizing regulations to better reimburse participants for out-of-pocket expenses and compensate them for their time.
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Additional Information
Print number: 118_S_1701
Sponsor: Sen. Menendez, Robert [D-NJ]
Process start date: 2023-05-18