What are the key barriers to patient participation in cGvHD clinical trials?

The GvHD Hub was pleased to speak with Steven Pavletic, National Cancer Institute, Bethesda, US. We asked, What are the key barriers to patient participation in cGvHD clinical trials? 

In this interview, Pavletic discusses key factors that may impact patient participation in chronic graft-versus-host disease (cGvHD) clinical trials, including the practical and emotional demands associated with trial involvement, as well as concerns regarding treatment-emergent adverse events and potential long-term effects of investigational therapies. He highlights the importance of empowering patients and involving them in decisions about their care, with clear communication helping to ensure that patients are well informed and have realistic expectations about trial participation. 

Key points 

• Supporting patient involvement in cGvHD clinical trials requires consideration of factors at both the healthcare provider and patient levels.¹ 
• Healthcare providers’ awareness of and familiarity with available cGvHD clinical trials may affect their ability to identify and engage with potentially eligible patients at the appropriate time.^1,2 
• Delayed recognition of cGvHD and access to specialist care may limit opportunities for patients to participate in clinical trials, highlighting the importance of timely recognition of cGvHD and access to specialist care post-transplant.^3,4 
• Clear communication between patients and healthcare providers is important when considering trial participation, with inadequate background information potentially contributing to unclear expectations about what the trial may involve for patients.^5–8   
• The practical demands of a clinical trial may affect patients’ willingness to participate, including the time commitment associated with appointments and concerns about invasive procedures such as biopsies.^3,7,9 
• Financial constraints can add to the practical demands of trial participation, with travel costs and time away from work potentially placing further burden on patients.^7,9 
• Concerns about treatment allocation may discourage patients from participating in a trial, particularly where they fear being assigned to a control arm rather than receiving the investigational cGvHD treatment.^9,10 
• Fears about the investigational product itself may also influence patients’ decisions to participate in a trial, including concerns about treatment-related adverse events and potential long-term effects of therapy.^7,11 
• A lack of empowerment may affect patients’ engagement throughout a trial, with healthcare providers playing an important role in ensuring patients with cGvHD feel involved in decisions about their care.^5,6,8 
• Emotional support is also an important consideration when patients are making decisions about clinical trial participation, as emotional distress and uncertainty may affect their ability to process information and make decisions about enrolment.^7,12 
• Patient retention is also an important consideration, with high visit and procedure burdens, adverse events, logistical and financial challenges, and difficulties related to transportation, caregiving, or other aspects of daily life potentially affecting continued participation.⁹ 
• In summary, several practical, emotional, and informational factors may impact patient participation in cGvHD clinical trials, underscoring the importance of clear communication and appropriate support to ensure patients are informed and equipped to navigate the trial process.    

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.