CTTI Holds Meeting to Refresh and Enhance Decentralized Clinical Trials Recommendations

The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Aug. 25-26 to discuss best practices on conducting research in remote and virtual settings, including lessons learned from the COVID-19 pandemic. The insights gathered will be used to refresh CTTI’s 2018 Decentralized Clinical Trials (DCT) recommendations and ensure that they offer the most current information for planning and operationalizing DCT solutions (i.e., remote and virtual visits, using local labs and healthcare providers, and direct-to-participant shipping).

During the meeting, relevant experts and key stakeholders—including investigators, patients, regulators, technology experts, sponsor representatives, and other groups—CTTI and attendees exchanged knowledge, insights, and current solutions for using DCT solutions in clinical trials.

They also identified some important themes and identified opportunities to increase adoption of DCT solutions moving forward:

• Design with Purpose. The design of DCTs must prioritize patient safety and data quality. DCT elements should only be incorporated into study design where they are appropriate to the purpose of the study.
• Engage Everyone. It’s important to engage all stakeholders in DCT protocol design and implementation.
• Think Ahead, Early On. Careful planning and consideration from the earliest stages of study and program design is essential.
• Invest in Quality. DCTs are often not the cheapest or easiest solution, but they can be the most impactful in terms of making trials more patient-centered and getting the best data.
• Where to Focus Next. Communication, collaboration, and regulatory guidance are critical for broader adoption of DCT solutions.

CTTI is now updating its recommendations and will make them available by early 2022 to help accelerate the adoption of DCT solutions in clinical trials going forward.