What approaches could improve recruitment and retention in cGvHD clinical trials?

The GvHD Hub was pleased to speak with Corey Cutler, Dana-Farber Cancer Institute, Boston, US. We asked, What approaches could improve recruitment and retention in cGvHD clinical trials?  

In this interview, Cutler discusses strategies to promote recruitment and retention of patients in chronic graft-versus-host disease (cGvHD) clinical trials. He highlights the importance of broad eligibility criteria, as well as opportunities for patients to participate in both therapeutic and non-therapeutic cGvHD research. He also emphasizes the need to consider the patient perspective when designing trials, including the time, travel, and assessment burden associated with participation. 

Key points 

• Broad eligibility criteria can support recruitment in cGvHD clinical trials by allowing patients across different clinical phenotypes and organ manifestations to participate.^1,2 
• This could include trials using a master protocol framework, which allow multiple therapeutic interventions to be evaluated within a single overarching protocol across different patient populations.^3,4  
• In addition to therapeutic clinical trials, patients should be made aware of opportunities to participate in non-therapeutic research, including natural history and longitudinal trials, which are important for advancing understanding of cGvHD.⁵ 
• Patient retention should be considered from the outset of trial design, with trial schedules designed to minimize the burden of participation by consolidating the number of in-person visits and, in turn, associated travel time for the patient.² 
• Considering the patient perspective when designing trials can help ensure that study outcomes are relevant to their experiences.⁶ 
• Moreover, keeping patients informed about trial outcomes can help reinforce the value of their participation by demonstrating the contribution their involvement has made to the research and its potential benefits for future patients.^7,8 
• In summary, patient-centered trial design is key to improving recruitment and retention in cGvHD clinical trials, including eligibility criteria that reflect real-world practice and study procedures that minimize the logistical and assessment burden for participants.

This educational resource is independently supported by Sanofi. All content is developed by SES in collaboration with an expert steering committee. Funders are allowed no influence.