Decentralized clinical trial (DCT) models—clinical studies that use technology and processes or strategies to go beyond on-site locations—evolved in response to the COVID-19 pandemic. Although DCTs reduce the in-person contact required in traditional clinical trials, they pose unique challenges and require careful consideration in design, technology selection, and execution.
Pennsylvania-based software company, YPrime, offers cloud-based technology and expertise to help clients respond to these unique challenges. The patient insights and engagement team develops trial strategies and tools to keep patients more informed, boost compliance, and improve retention. Their scientific experts help focus on the endpoints and timepoints that answer the most important research questions and meet regulatory expectations. The data science team are leaders in building new protocol-specific integrations with other platforms, medical devices, and applications. YPrime’s technology solutions transform the design and execution of clinical trials, improving patient data collection, and simplifying clinical supply management.
As explained by Kelly Franchetti, Senior Vice President, Global Head Patient Insights and Strategy at YPrime: “Technology solutions help to broaden opportunities for patients to participate in clinical studies, help sponsors and sites monitor the patients’ progress in real time, and help maintain scientific rigor in the data collection process.”
Advanced outcome assessment
Using YPrime’s electronic clinical outcome assessment (eCOA) technology, the company works with a trial sponsor to develop a therapeutically-driven solution that is easy for patients to use. YPrime’s data-science team works with a trial sponsor to integrate a protocol with the eCOA. Plus, YPrime’s scientific experts help a sponsor select endpoints that yield answers to a trial’s key questions and provide regulatory compliance.
The resulting eCOA focuses on the patient experience. Patients can use their own devices to participate in a study. An easy-to-use and intuitive format keeps patients engaged and compliant. Plus, the cloud-based eCOA technology ensures data security.
The cloud-based foundation of YPrime’s eCOA technology brings additional benefits to DCTs. For instance, near real-time data allows quality monitoring throughout a DCT and supports decision making. Plus, YPrime’s data-monitoring service warns a sponsor about safety and compliance issues.
Overall, YPrime’s eCOA delivers cleaner data, enhanced clinical trial efficiency, increased site satisfaction, and improved patient compliance.
Interactive response technology
Interactive response technology to manage all aspects of global patient randomization and clinical supplies can help reduce the complexities of designing for and executing on patient-centric clinical trials. YPrime provides best-in-class IRT solutions that ensure statistical integrity, reduce risk, and deliver submission-ready data at the end of every clinical trial. Flexible IRT designs can accommodate remote, hybrid, and onsite visit schedules, unique dispensation needs, and multiple direct-to-patient clinical supply shipping models.
Patient insights and engagement
YPrime works with patients, care partners, healthcare providers, patient advocacy groups, and payers to develop the most meaningful and beneficial relationships with all stakeholders in a DCT. In terms of working with patients, for example, YPrime interacts with family and patient advocates—even collecting information on attitudes and emotions—to determine what matters the most in their daily lives as well as treatments. Based on this information, YPrime can test hypothetical protocols—from patient education through data collection—and possible patient-reported outcomes. By combining the patient information and test protocols, YPrime can design a DCT that optimizes methods of outreach and supports patients with adherence—all tuned to the needs of specific patient populations.
Plan for success
The most successful organizations and studies align the protocol, patient type, and therapeutic area through a collaborative effort with partners, minimizing burdens and risk, while maximizing the effectiveness of the technologies applied. The patient journey needs to remain at the heart of designing technologies and strategies for patient-centric trials. “Patient-centric clinical studies are a critical outgrowth of the digital health revolution, giving patients an active role in the drug development process, from clinical study design through to expanding treatment opportunities for more patients,” says Mark Maietta, President, YPrime. “Clinical trial technology can bring transformative benefits but requires deep understanding of the entire process and the lived experience of patients who navigate that journey.”