Today, 17 organizations sent a letter to Senate HELP Committee leaders, urging them to consider addressing state licensing limitations in clinical trials in the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).
The discussion draft of the PREVENT Pandemics Act was released by Senate HELP Committee leadership last week. This bipartisan legislation is focused on strengthening the nation’s public health and medical preparedness and response systems in the wake of COVID-19.
Section 502 of the PREVENT Pandemics Act is focused on modernizing clinical trials, and would require the FDA to issue three pieces of guidance to modernize and improve clinical trials, including the use of:
- Digital health technologies in clinical trials to help improve recruitment, participation, and data collection.
- Decentralized clinical trials to improve trial participant engagement and advance the use of flexible and novel clinical trial designs.
- Seamless, concurrent, and other innovative clinical trial designs to support the expedited development and review of drugs and biological products.
The letter urges the Committee to consider an additional requirement of the FDA to include in this section in order to address state licensing limitations that effectively prohibit clinicians working on clinical trials from recruiting patients from outside the state in which they are licensed, thereby diminishing the impact of the federal changes aimed at decentralizing clinical trials. This is especially important for rare diseases affecting fewer than 200,000 people in the United States, for which utilizing clinical trials across state lines, enabled by telehealth, may significantly increase the likelihood of a successful and diverse clinical trial.
To read the full letter, click here or see below: