Data Asset Series
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The Big Picture
Guardian Research Network (GRN), a non-profit organization, is a nationwide health system research consortium focused on advancing technology to accelerate cures for life-threatening diseases such as cancer, rare diseases, diabetes, and others. GRN works with life sciences clients and health system members to increase participation in data-driven clinical trials, optimize therapeutic and diagnostic studies, and employ real-world data (RWD) to improve patient access to precision medicines in underserved communities. For more, visit www.guardianresearch.org.
Data Capture
What kind of data do you have?
Response:
Electronic Medical Records (EMR). Our data includes information on 40 million patients, and tissue or blood samples, from diverse disease types and more than 3.5+ million oncology patients that goes well beyond traditional EMRs to include:
- Labs, specialized tests, and imaging
- Advanced & molecular biomarkers
- Genetic profiles & genomic sequencing
- First, second, third line, etc., treatment
- Tumor morphology and histology
- Patient characteristics and status
- Tele-health, pharmacy, and hospice details
What are your sources?
Response:
GRN’s records are directly sourced from our member health systems and third-party referral groups. Since patient identifiers are securely associated using an Honest Broker system according to HIPAA standards, GRN can share deeper, more actionable clinical insight than provided by other data providers that use only de-identified data.
What is the granularity of the data?
Response:
GRN’s attention to PHI security allows us and select study coordinators at trial sites to have access to secure patient identities. Should questions or additional information be required, GRN has created and implemented a two-way communications app used with our network physicians and healthcare professionals directly visiting with and caring for patients.
What is the frequency of data refreshes?
Response:
Our proprietary software, GRN Fusion, enables secure daily data extraction from our network members, returning near real-time data and reliable results for clinical research. Using this secure app inside our network, GRN Fusion provides a path for raw EMR data to be extracted, processed, and transferred to GRN as a limited data set on a daily basis. Upon arriving at GRN, the data set is loaded into the GRN system, harmonized, and processed, and then life sciences organizations can take full advantage of patient matching for research trials, patient cohort evaluation for study feasibility, and subject enrollment.
How much is the Data lag?
Response:
Because we access data directly from network member EMRs, there is virtually no lag. We capture timely, complex information—from rigorous EMR documentation to genomic profiling. Often internal systems or other vendor systems have diverse interoperability, creating data points that do not connect well, are limited by missing elements, are stale and not current, or include data not easily integrated into a useful view of the patient.
What is the overall capture rate?
Response:
Records of at least 1,000 patients are available in 32 + states in the U.S.
Strengths
Humanity and Technology: Faster comparator cohorts and clinical trials
Powered by an RWD system, GRN initiates virtual comparator cohorts and clinical trials faster and more cost-effectively than other networks without losing the human touch. GRN’s attention to PHI security allows us and select study coordinators at trial sites to answer real-world questions or gather additional information as required. With its two-way communications app, GRN has created and implemented a communication method used with our network of physicians and healthcare professionals who directly visit and care for patients.
Combining clinical experts and operational teams who function as a single entity, we can drill deeper into real-world data with multi-faceted disease knowledge. While our advanced technology enables much of what we do, GRN provides a human touch to elucidate a richer picture of a patient’s journey in real-time. Our daily data refreshes enable timely and insightful decision-making for life sciences teams. Also, GRN’s clinically-verified patient review allows for nuances in unstructured data to be reviewed and captured by clinical professionals. This enables judgment, timing, and other qualitative considerations to be factored into a decision. All of these help GRN focus on the clinical data most valuable and up-to-date for diagnostic and therapeutic entities that want to shorten the timeline to FDA approval and market launch. Over the years, this “white glove” approach with both health systems and life science partners has allowed us to achieve our vision of a no-patient-left-behind network.
Real World Data Adoption
Our goal is to increase participation in data-driven precision medicine trials, partner with the best companies to drive adoption of RWD for clinical research and improve community patient access to novel therapies. With proprietary technology and experienced clinicians, we help life sciences teams gain approval of FDA submissions—from new drugs, diagnoses or devices, to label extensions and longitudinal outcomes tracking.
Generally, pharma, biotech, CROs, diagnostic companies, and others have used GRN to support all phases of clinical trials, product development studies, commercial and clinical assessments, and supplemental external comparators. By providing real world data and IT expertise for clinical research trials, population health studies, and precision medicine research, GRN empowers life science researchers with integrated, harmonized EMR data, refined analytics, and sophisticated technology, as well as clinical service.
HIPAA, PHI, Privacy & Security
As a leader in healthcare technology and real world data, information security is important to GRN’s non-profit mission of translating data into cures. GRN is pleased to include validation of its data and IT security with the System and Organization Controls (SOC) 2 Type 2 Attestation as a key part of its security processes. As a voluntary compliance standard, this verification reflects GRN’s commitment to the highest levels of data security and demonstrates our adherence to critical security practices in IT and information-related risk mitigation.
This SOC 2 independent audit attests to both the design and the operating effectiveness of our security controls and provides assurance of how our IT systems are configured and used on a daily basis.
In addition, GRN uses anonymized, de-identified data in line with federal best practices for protecting research subjects’ privacy. Before de-identified data sets are released to third parties, the data is anonymized, deidentified, and reviewed by a series of evaluators, including the GRN Compliance Department.
Use Case
- GRAIL: Our data knowledge and expertise produced enrollment goals in record time with 8 GRN sites (representing only 6% of study sites) enrolling 3,029 (20%) study subjects. Recently, this led to introduction of a newly introduced blood test to detect cancer earlier.
- Multiple Myeloma External Comparator Arm for top 10 pharmaceutical company: GRN suggested use of a virtual comparator arm study for a large pharma clinical research project. GRN’s RWD was part of an FDA-approved application accepted for the first-in-class CAR T cell therapy for adults with relapsed/ refractory MM.
- Additional studies and published materials can be found https://www.guardianresearch.org/publications/.
Gaps
As with many other data vendors, the healthcare data GRN provides is specific to the US.
How to Start Exploring
GRN provides subject counts according to the sponsor’s specific data model and are available as complementary service upon initiation of a research project request. GRN Data Science has multiple avenues of subject identification according to precise sponsor data models and we are very transparent to only include the subjects likely to yield a final result.
Pharma clients may read about our recent events and projects on our website, https://www.guardianresearch.org. Life Science clients or interested parties may contact us directly by emailing Adam Chasse, M.H.A., Executive Vice President & General Manager, Clinical Services, chasse@guardianresearch.org (therapeutic clinical trials, diagnostic trials, and tissue studies) or Andrea McCracken, Director of Real World Evidence, amccracken@guardianresearch.org (RWD studies and registries).
GRN works with a wide range of Life Science sponsors. Our pricing is simple and transparent based on the needs of a specific protocol. For trials that involve consenting subjects, we follow a standard pricing model based on number of visits and trial activities.
For data science studies, GRN offers a range of real world data services. We strive to employ pricing and processes according to precise customer needs.
Typical GRN data services include:
- Extensive RWD project feasibility studies—including cohort construction, curation of a limited number of subjects to ensure data completeness and accuracy.
- Creation of deep datasets for hundreds or thousands of subjects for a specific disease area. This includes a license fee and a per subject fee depending on the complexity of the data model.
- Construction of a longitudinal disease area dataset as a multi-functional research platform with up to several thousand subjects.
- Single curator data entry for exploratory studies.
Double data entry with full business quality rules for FDA-ready datasets. - Regulatory datasets are auditable by the sponsor and regulatory authorities.
- GRN senior data scientists are available for FDA and other regulatory meetings.
- Statistical support for comparator cohorts and subject matching is available.
Where do you see healthcare data used by pharmaceutical manufacturers evolving in the next 2 - 3 years?
GRN has a mission to advance community hospitals and providers—historically left out of many research efforts—as critical partners in innovative R&D to provide the best quality data for novel real-world studies while continuing the parallel delivery of more traditional clinical trials.
Healthcare data will continue to be used by regulatory agencies, guideline working groups, and individual physicians for decision-making, while RWD-enabled trials will accelerate the R&D process and shorten time-to-market. As GRN and other networks and tech companies advance ways to organize the large but disorganized modern EMR, GRN sees itself and its member physicians/data scientists as being able to provide a pivotal service to pharma for interpreting healthcare data from the “real world.”
GRN members will increasingly be a key source of truth for answering pharma and biotech research questions. As the definition of drug research broadens greatly with new technology, we see a more expansive continuum of research which will always include traditional pharma and regulators, but will also enable community hospital research leaders to embark on their own discovery projects in healthcare. They will ask and answer their own research questions to inform how to best care for their patients. The ability to transform providers into highly functional researchers will enable the transformation of the old healthcare system to a new, highly-responsive, learning organizations of the next generation of payer-providers.
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