Unleashing Patient Insights: Transforming Clinical Trials with Patient Perspectives

At SCOPE Summit Europe 2024, industry leaders gathered to explore the transformative potential of patient perspectives in decentralized clinical trials (DCTs). The session, led by Ylenia Paleari and Marisa Minetti from Chiesi Farmaceutici SpA, focused on how integrating patient insights can enhance patient-centric clinical research. The discussion highlighted the pressing challenges of patient recruitment and retention in traditional clinical trials and proposed innovative solutions through a decentralized approach. The session aimed to pave the way for a more inclusive and effective clinical trial landscape by leveraging digital tools and fostering collaboration with patients and healthcare professionals.

Bridging Patient-Centric Research and Decentralized Trials

The session served as a crucial platform to discuss integrating patient-centric research with decentralized clinical trials. This shift is becoming increasingly vital in the clinical research field. Ylenia Paleari and Marisa Minetti highlighted the industry’s significant challenges in patient recruitment and retention, often due to the cumbersome nature of traditional clinical trial models. They outlined the complex journey of a clinical trial, which begins with the design phase involving patient population identification, setting objectives, and planning assessments. This journey continues through stages of awareness, interest, and intent, leading to recruitment, a multifaceted process involving eligibility checks conducted in clinics, over the phone, or online. Informed consent, traditionally involving a paper-based Patient Information Sheet (PIS), can be time-consuming and may deter potential participants. The decentralized approach aims to streamline these processes by leveraging digital tools and remote communication, making participation more accessible and less burdensome for patients.

The speakers emphasized that the decentralized model offers significant advantages, such as increased accessibility and convenience, but also presents challenges that must be addressed to ensure its success. One of the primary benefits of DCTs is the reduction in geographical and mobility constraints for patients. Traditional trials often require participants to travel to specific sites for study visits, which can be a significant barrier for those with limited mobility or those living in remote areas. By incorporating telemedicine and digital health technologies, DCTs can minimize the need for travel, allowing patients to participate from the comfort of their homes. However, the shift to a decentralized model must be carefully managed to maintain the essential human element of clinical trials. Both patients and HCPs strongly preferred retaining some level of face-to-face interaction, which is crucial for building trust and ensuring that patients feel supported throughout the trial process. The challenge lies in finding the right balance between digital innovation and personal interaction.

Reducing Travel Burden and Enhancing Flexibility

The session’s significant focus was strategies to reduce the travel burden on patients while maintaining the integrity of the doctor-patient relationship. The speakers presented data from a study involving 108 patients and 29 caregivers from the USA and Europe, which provided valuable insights into patient preferences and expectations. Participants in the study expressed a high level of interest in a Direct-to-Patient (D-t-P) service, which would allow them to receive study medication and conduct assessments at home. This service was seen as a way to alleviate the logistical challenges associated with frequent travel to study centers. Patients highlighted the benefits of having a better balance between their personal and working lives and the flexibility to choose when to visit the study center based on their own needs.

The speakers emphasized that implementing such services requires careful planning and patient collaboration to ensure the technology is user-friendly and meets their needs. The industry can enhance patient satisfaction and engagement by doing so, ultimately leading to more successful trial outcomes. The D-t-P service represents a significant shift towards patient-centricity, offering participants greater control over their involvement in clinical trials. This approach reduces the logistical burden on patients and empowers them to make decisions that align with their personal circumstances and preferences. The industry can foster a more inclusive and supportive clinical trial environment by prioritizing patient needs and preferences.

Building Trust in Clinical Research

Building trust in clinical research was identified as a cornerstone of successful patient-centric and decentralized trials. The speakers outlined Chiesi’s approach to fostering trust through various initiatives designed to enhance the patient experience and ensure transparency throughout the trial process. Chiesi’s strategy includes implementing hybrid DCT studies, which combine elements of traditional and decentralized trials to offer a flexible and patient-friendly approach. The company also provides a patient concierge service, which offers personalized support to participants, helping them navigate the complexities of the trial process.

Additionally, Chiesi has introduced direct-to-patient medication delivery, allowing patients to receive their study medication at home. This approach reduces the need for travel and ensures that patients have timely access to their medication, which is crucial for maintaining treatment adherence. The speakers highlighted the importance of clear communication and transparency in building patient trust. By providing lay summaries of study results and sending thank-you letters to participants, Chiesi aims to acknowledge the valuable contributions of patients and foster a sense of partnership in the research process. The company seeks to create a more inclusive and patient-centric clinical trial environment through these efforts.

Conclusion

The session concluded with a call to action for the industry to adopt innovative digital tools and collaborate with patients to enhance the usability of decentralized trials. The industry can overcome existing challenges by integrating patient insights and creating a more inclusive and effective clinical trial landscape. The session highlighted the critical role of patient perspectives in shaping the future of clinical research, paving the way for more patient-centric and decentralized approaches.