The pharmaceutical industry is moving beyond relying solely on first-party data collected from clinical trials and other studies to incorporating real-world evidence (RWE) derived from real-world data (RWD) in order to more fully support regulatory submissions. In fact, from January 2019 to June 2021, there were 116 FDA approvals citing RWE, with 83 supporting therapeutic context and 88 supporting safety or effectiveness.1 This trend has only accelerated in the past 24 months and data science teams are beginning to better understand the power of a multi-pronged approach.
With the advantages that RWD can provide, pharma companies are shifting to patient-centric RWD strategies. There are; however, challenges and concerns to consider on a number of fronts. Whether you’re using RWD for R&D, to conduct HEOR studies, research potential new indications, or for commercial endeavors, such as determining if a patient is taking a drug, providing support to help them stay adherent or getting on formularies, you have to be cognizant of patient consent, regulatory compliance, and a patient opting out or being lost to follow up. For an ideal RWE strategy, pharma companies want to:
You cannot; however, achieve all of these objectives with legacy tokenization techniques. HealthVerity recently hosted a webinar that discussed how a synchronized approach can help you realize the true potential from RWD. If you missed the webinar, here’s a brief recap:
There are six fundamental factors for successfully incorporating RWD:
Legacy tokenization vendors fall short on delivering against these fundamental factors. In fact, it’s time to sync different.
By synchronizing transformational technologies with the nation’s largest healthcare and consumer data ecosystem, HealthVerity is able to provide the ultimate source of truth in patient Identity, administer built-in data Privacy and HIPAA compliance, offer Governance of data usage rights and permissions, ultimately enabling the efficient discovery and Exchange of fully interoperable healthcare and consumer data with a single contract. This is known as our IPGE approach.
Unlike legacy tokenization, HealthVerity centralizes identity management, assigning one universal HVID per patient, rather than creating a new token every time we see an individual. We match to a patient master built on over 200 billion healthcare and consumer records, representing most of the patients in the U.S. By synchronizing patients across our data ecosystem, we can provide 10x greater accuracy than traditional tokenization, with an average false negative rate of only 3% and a false positive rate of approximately 0.2%.
Our more than 75 data partners that participate in HealthVerity Marketplace trust the IPGE approach. Because our data partners trust us, our accuracy and our ability to govern their data assets, we are able to offer the nation’s largest healthcare and consumer data ecosystem, where we ingest and host the data, providing full transparency and data provenance. All of the data within our ecosystem is HIPAA compliant and interoperable, allowing for the near limitless exchange of research-ready data.
With our IPGE approach, we are able to offer HealthVerity FLOW, a 21 CFR Part 11-compliant solution for synchronizing patient journeys from clinical trials to launch and beyond, including building registries to recruit patients for research studies, conducting safety/phase 4 studies, or for post-launch activities where a patient enrolls through a website or digital outreach.
No matter the use case, HealthVerity FLOW offers a modularized approach to synchronize identity, privacy and governance with on-demand data exchange:
This solution enables you to source, retrieve and deliver data into data stores, either you’re own data stores or those hosted by us, with identifiable data being kept separate from de-identified data and the ability to synchronize your first-party data, while maintaining a HIPAA-compliant firewall between the two.
Beyond tokenization, HealthVerity FLOW allows the data to flow where you need it, when you need it, how you need it, and flows throughout the product lifecycle.
1 Pupura, Christina A., et al (2022). The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications. Clinical Pharmacology & Therapeutics, 2022 Jan; 111(1): 135-144. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299054/