To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
On the patient side, patient journey coordinators (PJCs) work closely with sites to address challenges that extend beyond medical requirements. From managing work schedules and childcare needs to ensuring patients can attend appointments easily, PJCs focus on minimizing barriers for trial participants.
This patient-centered role directly supports trial engagement, helping patients feel valued and making participation less burdensome. By integrating personal touchpoints with operational efficiency, PJCs improve the likelihood of patients staying engaged throughout the trial, benefiting both participants and the overall study.
As hybrid and decentralized trials become more prevalent, the role of both CSAs and PJCs becomes even more critical. An effective approach involves a combination of on-site and remote monitoring, with central monitoring teams reviewing data to detect trends or issues requiring immediate attention.
CSAs and PJCs provide support to help sites manage the unique demands of decentralized trials, ensuring that patient engagement remains high and that sites stay on track with trial requirements. This focus on tailored, individual support models draws from best practices in rare disease trials, in which customization has long been essential.
Rare disease trials often face unique challenges, such as patient recruitment, complex endpoint selection, and strict data integrity requirements. These trials have pioneered individualized approaches that can now be applied more broadly.
The lessons learned from rare disease research underscore the importance of considering each trial’s unique requirements at the start, ensuring every aspect of the trial is aligned with its specific protocol for a clear, optimized path forward.
As the clinical trial industry continues to evolve, the need for personalized support for both sites and patients is likely to increase. A tailored approach not only alleviates stress for sites and patients but also enhances the success of clinical studies.
For sponsors aiming to elevate their trial operations, the lesson is clear: prioritizing both patient and site support is essential in today’s complex research environment.
About the Authors
Samantha Morley, Senior Manager, Clinical Monitoring, Advanced Clinical; Danielle Shadforth, Clinical Monitoring Manager, FSP, Advanced Clinical; Nishma Patel, Senior Program Manager, Advanced Clinical.
ABOUT ADVANCED CLINICAL
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. Visit our website to learn more: www.advancedclinical.com.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.