Meeting Objectives:

In order to update CTTI’s existing decentralized clinical trials (DCT)* recommendations, this expert meeting aimed to:

• Collect recent knowledge and insights – both what works and what doesn’t – from operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping)
• Understand current practices for incorporating DCT solutions in clinical trials, including considerations for protocol design and safety monitoring
• Identify opportunities to increase adoption of DCT solutions moving forward

*For the purposes of this meeting, DCTs were defined as those executed through telemedicine and mobile/local healthcare providers, using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product is shipped directly to the trial participant).