The Society for Clinical Research Sites (SCRS) European Site Solutions Summit 2023 served as a pivotal gathering for clinical research professionals and clinical trial sites focusing on the advancements and challenges in clinical trials from the perspective of research sites. This year’s summit was marked by insightful contributions from esteemed panelists, including Clare Campbell-Cooper, Global Head of Digital Health & Innovation at Fortrea, UK; Elias Ketiar, MD, MRCP, Clinical Vice President of Science & Medicine at Signant Health; and Sarah T’Kindt, Pharm, GCP Inspector at the Federal Agency for Medicines and Health Product (FAMHP), Belgium. Their diverse backgrounds brought unique insights into integrating digital tools in clinical trials, regulatory compliance, and the evolving role of clinical research sites in the rapidly changing landscape of clinical trials.
Adapting to Digital Health: The Clinical Trial Site Journey
A central topic at the summit was integrating digital tools into clinical trials. One speaker shared an enlightening case study about the implementation of ePRO at their site, discussing the initial challenges in staff training and patient compliance. As another speaker noted, this transition to digital tools like remote monitoring devices, while enhancing patient engagement, also necessitated an overhaul in data collection methodologies, highlighting a blend of opportunity and challenge for clinical trial sites.
Navigating Regulatory Complexities
The summit provided an in-depth look into the regulatory landscape from a site’s perspective. A panel discussion featuring a GCP Inspector highlighted compliance intricacies with evolving guidelines such as ICH E6 and E8. A poignant example was shared about a site grappling with implementing these guidelines in a real-world setting, stressing the need for constant vigilance and adaptability in regulatory compliance.
Decentralized Clinical Trials: A Double-Edged Sword for Sites
DCTs were a significant theme, with discussions oscillating between their potential benefits and inherent challenges. One session highlighted a case where a site expanded its patient reach through DCTs but faced logistical hurdles in remote data collection. The conversation underscored how DCTs, while reducing patient travel and broadening recruitment scope, bring complexities in workflow integration and patient monitoring for clinical trial sites.
Emphasizing Patient-Centricity in Site Operations
Patient-centricity was underscored as a pivotal element in trial design and execution. A compelling example was provided where a site’s adaptation of patient-centric strategies, like flexible appointment scheduling and electronic informed consent forms, improved patient recruitment and retention rates. This summit segment emphasized sites’ crucial role in ensuring patient comfort and engagement.
The Imperative of Effective Training and Support
The summit recognized the crucial role of training and support in successfully operating sites, especially in the digital age. An interesting discussion revolved around a site’s journey in training its staff to use a new digital data management system, highlighting the challenges and successes encountered. This highlighted the need for comprehensive technical training and education on regulatory changes for staff and patients.
Data Management and Technological Integration: A Site’s Perspective
From a data management standpoint, sites are facing new challenges with digital integration. One keynote discussed a site’s experience integrating different digital platforms, emphasizing the struggle to ensure data integrity and system compatibility. This conversation highlighted the importance of secure, efficient data storage solutions for sites dealing with increasing digital data.
The SCRS European Site Solutions Summit 2023 offered rich insights into the multifaceted challenges clinical research sites face in the current clinical trial ecosystem. The discussions provided real-life examples and contextual understandings, from grappling with digital transformations and regulatory complexities to adopting patient-centric approaches and tackling data management challenges. As clinical trials continue to evolve, the adaptability and resilience of sites remain key to their successful navigation in this dynamic field.