Bridging clinical and real-world data
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.