Decentralized Clinical Trials (DCT) and hybrid trials are becoming more of a norm given the impact of the COVID-19 pandemic. By creating more patient-centered clinical trials, a decentralized approach can enhance pharma research by attracting a more diverse patient population and eliminating existing barriers to participating in research studies, including COVID-related limitations. Telehealth and remote patient monitoring (RPM) will play an important role in advancing decentralized technology-driven trials. To address this important opportunity to enable equal access to clinical trials by leveraging telehealth and virtual care technologies, the ATA has convened a member special interest group (SIG).

The goals of the group include:

1. Pursue policy/advocacy to remove barriers to allow interstate work and other legislation

2. Create practice guidelines to leverage existing telehealth and RPM solutions

3. Address issues of data flow, a subset of our work on telehealth interoperability

The new SIG has convened three subgroups to help achieve these goals in actionable increments, including partnership opportunities:

· Policy/Advocacy
o Identify the best entity to create and maintain a registry of state laws that impact conduct of DCTs
o Evaluate Drug Safety & Quality Act of 2013 for any barriers to implementation of DCTs

· Best Practices
o Leverage existing and create new content to help research sites understand what they need to do to participate in DCTs

· Data Flows
o Inventory existing standards impacting DCTs
o Look at ways to ensure adoption of most impactful standards

Meetings are the 4th Monday of the month at 3p Eastern.