In this interview, we speak with Dan Drozd, Chief Medical Officer at PicnicHealth, about the challenges and innovations in clinical trials, focusing on patient engagement, AI integration, and diversity.
Moe Alsumidaie: How do you tackle patient dropout and delays in decentralized trials?
Dan Drozd: Patient dropout and trial delays are significant challenges in clinical research, with up to 30% of patients dropping out and 80% of trials facing delays. These issues can cost between $600,000 and $8 million per day. To address this, we leverage virtual studies for passive data collection from electronic health records and claims, providing a comprehensive 360° view of patients. This approach enhances patient engagement and reduces their burden, crucially minimizing loss to follow-up. For instance, the FDA’s 2020 guidance on long-term follow-up for
CAR T therapy, which mandates 15 years of follow-up, exemplifies the burden on patients and sites. Our virtual-first approach alleviates this burden, ensuring better data collection and reduced costs. Focusing on patient engagement and decreasing the burden can improve data quality and trial efficiency, benefiting patients and sponsors.
Moe Alsumidaie: How do you ensure AI integration maintains data integrity and compliance?
Dan Drozd: AI, particularly large language models, offers transformative potential for automating data abstraction and protocol writing tasks. These models can achieve superhuman performance levels, but their black-box nature poses challenges. The FDA’s Good Machine Learning Practices emphasize a multidisciplinary approach, independent testing, and bias mitigation to ensure data integrity and compliance. While AI can enhance efficiency, human oversight remains crucial for explainability and data quality. For example, next-generation electronic data capture systems can operate centrally or be deployed locally at sites, ensuring data integrity. Risk-based quality management aligned with regulatory guidance is vital to leverage AI’s scalability while maintaining data quality. Integrating AI with human oversight can enhance trial efficiency while ensuring compliance and data integrity.
Moe Alsumidaie: How do you adapt to regulatory changes while innovating in research?
Dan Drozd: Adapting to the rapidly changing regulatory landscape is challenging. For instance, CDER issued 19 final guidance documents in the last 90 days. Staying abreast of these changes is crucial, and we engage early in developing new guidance, providing feedback to help shape it. Core principles such as data being fit for purpose, relevant, reliable, and transparent guide our approach. We encourage early and frequent engagement with regulatory agencies, especially when pursuing innovative projects. Recent guidance on using electronic health records and conducting decentralized trials are particularly relevant to our work, helping us align our technology with regulatory expectations. By maintaining a proactive approach to regulatory changes, we can continue to innovate while ensuring compliance and scientific rigor.
Moe Alsumidaie: How do you prioritize patient centricity and mitigate dropout rates?
Dan Drozd: Patient engagement is crucial for trial success. We build strong relationships with patient communities and advocacy groups to understand the patient’s burden of illness. Often, the outcomes measured in clinical research are not the most important to patients. Therefore, we incorporate patient-centric outcomes into trial design, providing a comprehensive view of their journey. Technology is vital in minimizing loss to follow-up and providing value to patients, whether through monetary compensation or services that ease their burden. Sharing results with patients is also essential, giving them insight into how their data contributes to new knowledge. Lowering the burden on patients enhances engagement and retention, allowing our customers to maintain closer connections with patients. This approach improves trial outcomes and fosters trust and collaboration with patient communities.
Moe Alsumidaie: How do you support biopharma companies in meeting scientific and regulatory demands?
Dan Drozd: Scientific and regulatory demands are closely intertwined, with scientific rigor being the cornerstone of regulatory acceptance. We leverage technology to push boundaries without sacrificing rigor or transparency. Success requires scientific and technical expertise to build an evidence-generation platform for the 21st century. This platform engages diverse individuals and provides a complete view of patient journeys. By maintaining high standards of quality and transparency, we ensure that the data generated meets both scientific and regulatory requirements, supporting biopharma companies in their submissions. Our approach uses technology to enhance data quality and trial efficiency, benefiting patients and sponsors.
Moe Alsumidaie: How do you ensure diversity and inclusion in your research platforms?
Dan Drozd: Addressing diversity is crucial, as evidenced by the FDA’s recent guidance on diversity action plans in clinical studies. In 2020, 75% of clinical trial participants were white, highlighting underrepresentation. Barriers such as time, resources, and study location limit participation. Technology lowers these barriers, enabling broader engagement. We also address historical mistrust, particularly in specific populations, by acknowledging and working to rebuild trust. Our tools focus on reducing the participation burden, enabling virtual participation, and rebuilding trust in disadvantaged populations. Doing so ensures our platforms are inclusive and efficient in gathering comprehensive data across diverse groups. This approach enhances trial outcomes and fosters trust and collaboration with diverse patient communities.
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.
