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The Patients’ Perspective on Decentralized Trials
Uncovering patients’ preferences, needs, and expectations when participating in a decentralized clinical trial.
Introduction
James Lind Institute has learned that gastroparesis is a disease with debilitating symptoms that significantly impact the daily lives of those who suffer from it. Few satisfactory treatments exist, so we decided to investigate the disease by asking our community members about their knowledge and experiences with its symptoms. Existing literature highlights many interesting aspects of the disease, and we have chosen to focus on the following:
- Long-standing diabetes is the most common known cause of gastroparesis
- Classic symptoms include nausea, stomach pain, vomiting, bloating, and early satiety
- Most patients report experiencing these symptoms as severe or very severe
- Most patients expect their health to deteriorate over time
- Most patients remain unsatisfied with the available treatments
Conclusions
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Decentralized trials can be the future concept
Patients are ready to abandon the classical trial model and express their willingness to wear technical equipment. They favor more participation from home, but this requires technical education and new retention services. -
Decentralization delivers both convenience and barriers
The majority of patients appreciate the idea of avoiding travel to sites, and they are open to wearing digital equipment. However, some barriers need addressing. If we do not address these issues properly, decentralized trials could reduce patient enrollment and retention instead of improving them. -
Dropout rates risk rising
The lack of personal contact with specialized health care staff at sites may leave patients feeling worried and demotivated, which could increase dropout rates. We should offer mitigating solutions to manage this risk effectively. -
Cost reductions require patient retention services
Decentralized trials present an opportunity to reduce costs by using fewer site resources. However, reducing site involvement may decrease motivation, leading to participant dropouts. To prevent this, sponsors might need to offer regular calls from nurses, as well as provide access to specialists and education on using wearables.
About James Lind Care
James Lind Care is a clinical trial-specialized European patient organization that facilitates national online patient communities and collaborates with sponsors to guide patients in their clinical trial engagement. With our large membership base and unique international presence, James Lind Care can address the challenges of patient-centricity in clinical trials, such as offering understandable communication, designing gentle protocols, and ensuring attentive enrollment.
Links to other publications: https://jameslindcare.com//wp-content/uploads/2025/01/Patient-Insight-Gastroparesis-Nov-2019-James-Lind-Inst_new.pdf