Linking Clinical Trial Data with Real-world Data: Q&A with HealthVerity
KC Ahlberg is a Director of Partners and Alliance Management at HealthVerity, one of Medidata Link’s clinical trial tokenization partners which supports patient-level linkage between clinical trial data (CTD) and real-world data (RWD). We spoke with KC to discuss some of the key trends related to the use of real-world data in clinical trials, and the value sponsors are realizing through data linkage.
How Are Sponsors Using RWD in Their Clinical Trials Today?
We’re seeing that sponsors are utilizing RWD across a broad spectrum of use cases throughout the development lifecycle, from more precise recruitment and feasibility assessments upstream to safety monitoring and comparative effectiveness research further downstream.
Sponsors are increasingly linking CTD with RWD due to a number of factors. Over the past decade, use of real-world data in clinical trials for FDA submissions has been growing, in large part due to the proliferation of high-quality data, new technologies that allow interoperable, HIPAA-compliant utilization of this data, and a rising acceptance and guidance for the use of real-world evidence by the FDA.
More importantly, proof of the value of data linkage in the real world is driving the uptick. Sponsors are seeing the tangible benefits of linking CTD and RWD through faster time to insights, evidence and, ultimately, approval.
How Can Sponsors Maximize Their Likelihood of Success When Using Real-world Data in Clinical Trials?
There are a few things sponsors should consider:
First, you can’t win if you don’t play. If you’re thinking about linking your trial’s CTD with RWD, plan for it regardless of uncertainty. The upfront investment of consenting and de-identifying participant data needed for privacy-preserving data linkage provides the option to link data in the future, which vastly outweighs the potential downstream challenges (e.g., reconsenting). In many ways this becomes an insurance policy as the data landscape continues to evolve, and affords the opportunity to socialize the concept and build support across your organization.
Second, really understand your research question, the nuances, and your end game. Be thoughtful about current and strategic context, as well as known (and unknown) evidence gaps, priorities, and value from the perspective of both internal and external stakeholders.
Last, your plan is only as good as your data. Be mindful to deeply interrogate the data you intend to incorporate to ensure it meets the purpose and need—data quality, completeness, relevance, and appropriateness are all paramount to success.
How Does Medidata Link and HealthVerity’s Partnership Support Sponsors Looking to Link CTD and RWD?
Medidata and HealthVerity bring together complementary offerings that empower sponsors to enhance evidence generation with minimal disruption to existing clinical workflows by linking CTD and RWD. Our partnership integrates the vast HealthVerity RWD ecosystem and our best-in-class patient matching and identity resolution capabilities with Medidata’s Clinical Cloud® platform that captures and manages personally identifiable information and patient consent. We compliantly enable comprehensive views of participants before, during, and after their trials, rapidly supporting wraparound research needs to evolve flexibly based on new insights or changes in the healthcare environment.
How Do You Expect the RWD and Real-world Evidence Landscape to Evolve in the Next Five Years?
We’re really just scratching the surface in many ways. A few themes to look for:
- Data linkage driving further integration of RWD into clinical trials: We’re certainly already seeing its supplementary use in the development cycle, but in the next five years, we’ll likely see further integration and effective use of real-world data in clinical trials. RWD will likely play a more central role before, during, and after trials—particularly as regulatory guidance and data standards grow. A host of new use cases will continue to move from concept to reality for many researchers.
- Broader embedding of advanced analytics: With zettabytes of health data, it will be crucial to have advanced analytics that can mine data for insights across multiple functional areas. To scale, we will need to see more analytically-focused interdisciplinary teams emerge that account for the clinical, technical, business, and statistical perspectives.
- Greater importance of patient centricity and related endpoints: It’s increasingly clear that it’s important to view the whole patient in healthcare, and RWD can provide these insights. With the proliferation of wearables and digital health capabilities, we will continue to have more detailed and refined views of patient-centered outcomes, such as quality of life, symptom relief, and functional status that can be incorporated into research.
Want to learn more about how data linkage and longitudinal patient insights can solve key challenges in post-market surveillance? Watch our recent webinar, featuring Sandy Leonard, SVP Partnerships and RWD at HealthVerity and Akiko Shimamura, Vice President of Medidata Link, on-demand:
Medidata Link, awarded the 2022 Innovations in Regulatory Science Award from the Reagan-Udall Foundation for the FDA, provides a path forward for sponsors to link clinical trial data with real-world data at the patient level to cost-effectively capture information on long-term efficacy, safety, and healthcare resource utilization. Read more about the use cases of linkage across the trial lifecycle.