COVID-19 has heightened the need for an expanded understanding of clinical trial populations and patient insights both during and post-trial. With more immediate access to real-world data, clinical trial design, study effectiveness and real-time research can improve drastically.
Sandy Leonard, VP RWE at HealthVerity was joined by Akiko Shimamura, Senior Director, Medical Analytics & Outcomes Research at Medidata for the latest HealthVerity Plus webinar: The role of RWE: Longitudinal patient insights bridging clinical and real-word data. The two discussed how the elimination of data silos amongst real-world and clinical trial data will advance real-world evidence and ultimately drive better patient outcomes in ongoing and prospective clinical trials.
If you missed the webinar, view the full recording to:
- Gain insights into how your key challenges in post-market surveillance are solved by integrating real-world data and clinical trial data.
- Learn how longitudinal patient insights (LPI) can de-risk your clinical trials, lower the costs of follow-up studies and enhance insights.
- Explore the critical components for successful implementation of LPI in your clinical development program (e.g., data privacy, security and compliance, expertise).
- Delve into cutting edge cases already underway with top pharma companies.
There is tremendous momentum and value in incorporating real-world evidence and real-world data into clinical development, but there are a few challenges in the way:
- Clinical trial data and real world data have existed as separate silos
- CTD = maintains a tightly controlled set of parameters; focusing on a subset of patients; regular intervals of assessment, greater depth of information, shorter follow up times; not necessarily representative of the real-world
- RWD = medical and pharmacy claims, EMR, labs, social determinants, device data; from large, diverse patient populations
- It’s well known that the data silos pose a major constraint on our ability to understand:
- The patient journey before the clinical trial
- What drives patient outcomes
- What happens to the patient after the clinical trial has ended, including long-term safety
This leads to missed opportunities:
- Clinical trials – There are often endpoints that cannot be measured within the confines of the trial. What if you could track long-term outcomes relevant for provider and payer discussions during or after the clinical trial?
- Lost to follow up – What if you could better understand what happens to those patients post-trial, or after they dropout?
- Innovative data – What if you could interface more directly with a patient (e.g., wearables to track activity), both during and after the trial?
- Phase IV trials – What if you could complement CRF data capture in Phase IV, with the patient’s real-world data to decrease the number of visits and procedures required and reduce patient and site burden?
- Post-marketing surveillance – What if you track patients after the clinical trial in real-world data and ahead of unexpected signals before full launch and market uptake?
The elimination of data silos and creation of longitudinal patient insights via the HealthVerity ID - a consistent and unique patient ID - allows for HIPAA-compliant, accurate linkage of clinical trial and real-world data.
View the webinar for the full conversation accompanied by detailed methodologies, use cases and live Q&A with the audience.
This conversation was the first in the new monthly HealthVerity Plus webinar series, where HealthVerity features its expansive network of data providers and strategic partners. Topics span the breadth of challenges in today's life sciences industry and showcase how we help solve for them through data and technology.