Synchronizing patient journeys from registries and clinical trials to launch and beyond
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:
- Know and trust third-party data sources
- Connect first-party data
- Ensure that RWD is comprehensive, timely and includes rich data attributes
- Receive continuous record-level data to follow the ongoing patient journey
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:
Six steps to synchronize the science
There are six fundamental factors for successfully incorporating RWD:
- Accurate patient identity resolution
It is imperative to ensure accuracy when matching patients across disparate data sources in order to have a comprehensive, longitudinal view of the patient journey. In your personal life, you probably wouldn’t use a GPS that only got you to the right destination 85% of the time, but that’s essentially what you settle for in your professional life with legacy tokenization techniques where the average false negative rate is 15% (a false negative is where the same person is tokenized to appear as multiple individuals). That error rate can be as high as 40% if the data is especially noisy. The industry standard for false positive rates (where different people are assigned the same token) using legacy tokenization is 2% or higher. - Data provenance for greater transparency
You want to know where your data comes from, who’s providing it and how it’s generated; not just for your own peace of mind, but to meet FDA guidance. When asked about the value of clinical data provenance and how much it matters, industry leaders told us:
“Short answer: A LOT”
“If companies can show the FDA that their data is clean and robust, it’s a plus”
“The value of data provenance to the FDA is huge.”
It’s not enough if your vendor can only tell you the data is from medical claims, but cannot reveal the identity of the actual source. - A broad data ecosystem
In order to unlock more of the patient journey and see what you couldn’t see before about a patient, you need a broad data ecosystem with a variety of sources and types, including open and closed medical claims, pharmacy claims, lab results, biomarkers, electronic medical records, hospital chargemaster, and consumer data. - Open access to data versus a walled garden platform
You want options and the ability to import first-party data or other third-party sources, even those that have already been tokenized, to ensure the most comprehensive view of the patient journey and meet your specific project needs. - Built-in HIPAA compliance for complex cohorts
Once you’ve sourced the RWD you need, you want to ensure HIPAA compliance, but you don’t want to have to wait six months for a certification before you can start working with the data. While some data vendors offer to certify data as well, it’s usually with an internal, company-controlled examiner, introducing an interesting conflict of interest. - Single contract for speed to market
Rather than being burdened with sourcing the various datasets you need, determining who to contract with, dealing with all of the legal, regulatory and compliance concerns, you want a single contract for multiple data sources to get your data faster so you can gather insights sooner.
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.
Go with the FLOW
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:
- Identity Manager - When a patient is enrolled in a trial, a study, a registry or engages through digital outreach, HealthVerity Identity Manager creates a universal HVID, creating a source of truth that allows you to easily discover their RWD.
- Governance Manager - HealthVerity provides governance of engaged patients’ consent and data rights, informing you of what’s allowed and what isn’t with regards to their data.
- HealthVerity Marketplace de-identified RWD exchange - With the source of truth, for patient identity and data permissions, rights and usage, you can discover and exchange broad-scale de-identified data for patients of interest.
- HealthVerity Consented Record Exchange - Just as easily access identifiable data with Consented Record Exchange from providers who typically have not shared their data in the past, providing novel insights.
- RWD Pre-Check - Within seconds, using a simple web-based form, determine whether RWD is available for that patient by checking against 330 million HVIDs, so you can make informed decisions on whether to engage the patient in the trial, study or other endeavors.
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/