Decentralized Clinical Trials
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.
Leadership
CEO and Chairman
BioIntelliSense
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SPECIAL REPORT
2019 State of the States Report
This comprehensive, state-by-state analysis includes a review of how patient settings, different technologies, and provider types are treated across the country, as well as detailed information on the unique policies dictating reimbursement and coverage of telehealth services in the U.S.