In this interview, Rachael Thomas Higgins, Chief Commercial Officer of PicnicHealth, offers her perspective on the pivotal role of technology in observational research. Rachael delves into the challenges and opportunities presented by virtual study models, AI integration, and the shift towards real-world evidence generation. Her insights illuminate how these innovations are reshaping patient engagement and data collection in the life sciences industry.
Moe: With 64% of leaders citing incomplete data as a challenge, how can tech solutions address this more effectively than traditional methods?
In my view, technology significantly simplifies the process of gathering complete data. Traditional site-based methods rely on patients visiting sites, which can be sporadic and incomplete. By leveraging technology, we can obtain a comprehensive picture of the patient more efficiently. AI and technology also provide faster insights, much like a Google search, allowing us to discover information more quickly than waiting for traditional trial processes. For example, instead of waiting for a patient to visit a site, technology can continuously collect data, providing a more holistic view of the patient’s health journey. This approach not only accelerates data collection but also enhances the quality and completeness of the data, addressing a critical challenge in observational research.
Moe: The shift towards virtual study models is evident. What drives this change, and how might it reshape real-world evidence generation?
The COVID-19 pandemic showed that clinical research could continue effectively in a virtual setting, encouraging 70% of leaders to consider observational research. Patient retention is a significant factor, as traditional site-based approaches often struggle to keep patients engaged. Virtual models meet patients where they are, reducing the burden and increasing engagement. Additionally, advancements in AI technology are being embraced, although some resistance remains due to a lack of understanding. The pandemic forced the industry to innovate rapidly, proving that virtual models could maintain, if not improve, the quality of research. This shift is likely to continue, as it offers a more patient-centric approach, ultimately leading to more robust real-world evidence generation.
Moe: How does the direct-to-patient model improve engagement and retention in virtual settings?
The direct-to-patient model lowers patient burden by making participation easier. Many patients face challenges in physically reaching sites, so virtual engagement reduces this barrier. It also empowers patients by giving them control over their health records, which is crucial in a fragmented healthcare system. With everyone constantly on their phones, direct engagement through mobile devices meets patients where they are, enhancing participation in research. For instance, patients can participate in studies from the comfort of their homes, using their smartphones to provide data and receive updates. This convenience not only improves retention but also ensures a more diverse and representative patient population in clinical trials.
Moe: Despite AI adoption, 46% cite limited understanding as a barrier. What steps should the industry take to close this knowledge gap?
It’s crucial to provide a clear understanding of what AI is and how it can be leveraged. Many in the industry claim to use AI without fully grasping its capabilities. Educating stakeholders on the specific applications and benefits of AI, and demonstrating successful use cases, can help shift the paradigm and encourage broader adoption. For example, during the pandemic, AI was used to quickly analyze vast amounts of data, leading to faster insights and decision-making. By showcasing these successes and offering training programs, the industry can demystify AI and promote its effective use in clinical research.
Moe: With 60% prioritizing long-term follow-up studies, how can virtual solutions ensure data quality that meets expectations?
Virtual solutions can unify data collection, providing a 360-degree view of a patient’s journey. This approach captures the complete picture beyond what a single site can offer. Streamlining study execution through virtual means reduces patient burden and improves engagement, which is critical for long-term studies mandated by regulators. By meeting patients where they are, we can maintain their involvement over extended periods. For example, long-term studies often require follow-ups over many years, which can be burdensome for patients. Virtual solutions allow for continuous data collection without the need for frequent site visits, ensuring high-quality data that satisfies regulatory requirements.
Moe: Platforms offering a universal patient record are gaining attention. What advantages do they provide over traditional data vendors?
Universal patient records offer a holistic view of a patient’s health journey, capturing data beyond isolated site visits. This comprehensive approach allows researchers to understand the long-term effects of treatments and gather insights more quickly. It facilitates faster drug development and ultimately benefits patients by bringing effective treatments to market sooner. For instance, by integrating data from various healthcare providers, researchers can track a patient’s health outcomes over time, leading to more accurate and meaningful insights. This capability is particularly valuable in understanding the real-world impact of treatments, which is essential for improving patient care and outcomes.
Moe: What constitutes real-world evidence, and how are companies utilizing this data for FDA submissions?
Real-world evidence reflects what happens in the real world without intervention. It can include structured data like diagnosis codes and unstructured data from healthcare settings. While currently used as a supplement in submissions, the goal is to have real-world data stand alone in regulatory processes. Companies are increasingly using real-world data for comparator arms in trials, and as these practices prove successful, they may become the norm in regulatory submissions. For example, during the pandemic, real-world data was used to assess the effectiveness of treatments in diverse populations, providing valuable insights that complemented traditional clinical trial data. As the industry continues to innovate, real-world evidence will play an increasingly important role in regulatory decision-making, ultimately leading to more effective and personalized treatments for patients.
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.
