3 Industry Insights from real-world projects on implementation of a Decentralized Clinical Trial (DCT) framework.
1. Include the patients and the investigators in the discussion
– An integrated part of a DCT Framework is to include patients and investigators in the discussion prior to implementing the capabilities. Sponsors may not truly realize how technology-savvy the patients are or what interventions they would be comfortable with having performed via decentralized capabilities. Involve site staff to assess their willingness to support patients with new technologies or processes.
2. Involve the study teams to encourage a shift in mind-set
– A shift in mindset is required when developing a study protocol to ensure the DCT framework is fully utilized. Involving the study teams in sessions to brainstorm what DCT capabilities can be used specifically within their Therapeutic Area helps push towards this shift, as well as provide a feeling of ownership and engagement by the employees.
3. Implement a cross-functional DCT group
– A cross-study group tasked with supporting clinical trial teams with selecting and implementing DCT capabilities can ensure that learnings and expertise are effectively accumulated. While ensuring a standardized approach across studies, drawing on the experiences of such a group also eases the burden of study teams, ultimately leading to a higher adoption rate.