In this interview, Joseph Kim, Chief Strategy Officer at ProofPilot, shares how to revolutionize clinical trials at study sites. Kim discusses strategies to reduce site burden, enhance patient engagement, and tackle recruitment challenges, especially for underrepresented groups. He also explores the future of trials with real-world evidence (RWE) and long-term follow-up.
Moe Alsumidaie: How does ProofPilot reduce site burden while maintaining data quality and patient engagement?
Joseph Kim: At ProofPilot, we streamline clinical trials by orchestrating tasks, technologies, and instructional content into a cohesive workflow. This approach reduces the mental load on study coordinators, allowing them to focus on conducting trials and delivering patient care without being overwhelmed by disparate instructions and tech. Imagine it as a clinical trial GPS, guiding coordinators through each step efficiently. This orchestration is akin to how Google Maps revolutionized navigation, enabling any driver to navigate a city efficiently. Providing a clear, step-by-step guide, we help sites scale operations efficiently, while maintaining high data quality and patient engagement. For example, when a study coordinator enters our platform, all they need to do is select a visit, and voilá, everything they need to properly conduct
that visit is laid out in front of them, eliminating the need to reference multiple manuals or flowcharts. This reduces site burden, alleviates tech proliferation and enhances the overall trial experience for both coordinators and patients. Our platform ensures that studies are conducted exactly as intended, which is the central plot of great science. And now our platform extends beyond trial conduct into recruitment and post-study engagement, providing a seamless experience from recruitment to return of results.
Moe Alsumidaie: What strategies do you use to ensure high compliance in decentralized trials?
Joseph Kim: Brick and mortar trials are hard enough when everyone is under the same roof and chain of command. Decentralized trials are exponentially harder. ProofPilot excels in managing decentralized trials by orchestrating the disparate stakeholders to ensure everyone is doing the right things in the right order. While we don’t position ourselves as a decentralized trial company, our capability allows us to effectively coordinate stakeholders not under the same chain of command or physical location. Thus, we maintain high compliance and data quality for Sponsors, even in decentralized settings, by ensuring that all tasks and technologies are integrated into a cohesive workflow. This approach simplifies the trial process and enhances patient engagement and retention.
Moe Alsumidaie: How do you balance customization for sponsors with standardized protocols in global trials?
Joseph Kim: At ProofPilot, we offer a highly configurable platform branded to the sponsor, allowing for a tailored clinical experience while adhering to standardized protocols and allowing for flexibility to integrate with other systems. Whether sponsors need a comprehensive end-to-end solution or specific components like recruitment or post-study engagement, our platform is designed to work well together or be mixed and matched with other technologies and sponsor-specific business processes. This flexibility ensures that sponsors can maintain their brand identity and meet their specific requirements, even in diverse multi-site global trials. By offering any combination of an all-in-one experience or a la carte modules, we enable sponsors to deliver the kind of experience they want without being too disruptive. This adaptability is critical to balancing customization with the need for standardized protocols, ensuring that each trial is conducted efficiently and effectively, while fitting well into the ecosystem of technologies and processes.
Moe Alsumidaie: How does ProofPilot address recruitment challenges for underrepresented populations?
Joseph Kim: Recruitment enablers, especially for underrepresented populations, require a focus on easing connectivity with the site and helping to educate folks prior to consent. At ProofPilot, we allow patients to schedule their first call with study coordinators, reducing phone tag, which is burdensome for many underrepresented populations who don’t have the flexibility to take calls as will or are available during normal business hours. This approach helps reduces frustration and drop-offs, ensuring the patient and the study coordinator are locked in for that critical initial interaction. Additionally, we can provide a cadence of information to patients between the initial call and the first visit, helping them understand the trial and what to expect. This proactive communication helps improve the health literacy for this population who may be unfamiliar with the research world, and ensures that patients are fully informed and comfortable with their decision to join the trial. By focusing on these aspects, we address the root causes of recruitment challenges and enhance the overall trial experience for underrepresented populations.
Moe Alsumidaie: How does ProofPilot adapt to the demand for RWE and long-term follow-up in trials?
Joseph Kim: Long-term follow-ups in clinical trials present unique challenges due to infrequent touchpoints. At ProofPilot, we address this by delivering a cadence of content and tasks to patients, ensuring a baseline level of high quality engagement. This integrated workflow enhances the patient experience and maintains engagement over time, even when touchpoints are months apart. By automating the delivery of instructions and reminders, we ensure that patients remain engaged and informed throughout the study. This approach reduces the burden on study coordinators and creates a high-quality experience for patients, ensuring that they receive consistent communication, encouragement and support.
Moe Alsumidaie: Is there anything else you’d like to add about ProofPilot’s approach?
Joseph Kim: We’ve intentionally built a team that provides a 360-degree view of clinical research perspectives, incorporating die-hard expertise from pharma, technology companies, sites, and patients. Our products are designed to scale in a cost-effective manner, with rapid ramp-up times and self-service capabilities, offering unmatched value to our clients. By bringing together diverse expertise, including external insights from patient influencers, site operators and Pharma, we ensure that our solutions are innovative, practical, and aligned with the needs of all stakeholders in the clinical trial ecosystem. This comprehensive approach allows us to deliver a well-informed, purpose-built platform that addresses the central plot of research – ensuring that patients and sites participate and conduct research with quality and ease.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
