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Corrona: Leveraging 'Big Data' for Improved Patient Outcomes
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Most scientists, by nature and by training, are in one business: Observe a knowledge gap, and fill it. With that in mind, in 2001, the founders of the Consortium of Rheumatology Researchers of North America (Corrona) LLC recognized that there was no database — independent of big pharma — that collected clinical data from both rheumatologists and patients on the safety and efficacy of emerging drug therapies.
Contrary to the traditional data collection model, in which individual pharmaceutical companies sponsor phase 4 clinical studies to assess the outcomes of their proprietary drugs, the founders of Corrona envisioned a more collaborative database that instead combined the post-approval safety study commitments of various companies into a single registry with several treatment cohorts.
From its foundation as a comprehensive rheumatoid arthritis registry, Corrona has since expanded to include datasets for a variety of autoimmune diseases, with services ranging from safety analysis to time-to-event analysis, along with comparative research, matched analysis, descriptive analysis and drug profiles.
“Corrona’s mission is to advance medical research and improve patient care by providing unique data on treatment efficacy and outcomes of patients with autoimmune diseases in a real-world setting,” Leslie R. Harrold, MD, MPH, chief scientific officer at Corrona LLC, and associate professor of medicine at the University of Massachusetts Medical School, told Healio Rheumatology. “Our goal is to gain a deeper understanding of patterns of care, effectiveness and safety outcomes in autoimmune diseases.”
Insights amid Changing Times
An important component of the registry is granular data consistent with what is captured in randomized controlled trials, according to Harrold. She added that the company has remained agile enough to evolve with the times.
Over the past 18 years, Corrona has expanded to include registries on multiple autoimmune diseases including gout, inflammatory bowel disease, psoriatic arthritis/spondyloarthropathy, psoriasis and multiple sclerosis. “Data from these registries are used to derive insights on patient care, treatment effectiveness and safety of medications,” Harrold said. “The information that Corrona has gathered since 2001 has been used to generate over 430 abstracts at medical conferences and 144 manuscripts.”
Corrona is one of the largest RA real-world prospective data sets with more than 51,000 patients enrolled and more than 184,000 patient-years of longitudinal data available. The Corrona RA registry offers physician and patient data from clinical visits, as well as personal health information for approximately 10,000 patients, which enables visitors to cross-reference the findings to other data sets.
“Data is collected from patients and providers in the course of routine care through questionnaires,” Harrold said. “We revise our questionnaires every year or 2 in response to the changing landscape. This allows us to capture information on new medications and new adverse events. As Corrona has refined its safety surveillance infrastructure and processes, the company has expanded its capacity to provide customized pharmacovigilance services to support FDA and other regulatory agency commitments.”
To date, Corrona has supported fourteen molecules in their post-approval safety commitments.
The registry has also contributed significantly to the understanding of safety and efficacy parameters for DMARDs, biologics and small-molecule drugs. These contributions have come in the form of outcome data, interpreting risks for cardiovascular, infectious or malignant comorbidities, along with prescribing patterns that impacted the American College of Rheumatology’s DMARD guidelines for RA.
Data in Action
The services of the group are broken down into medical affairs, and safety. For the commercial work, Corrona intends to link their deep clinical data to claims and related data sets, based on the HIPAA-compliant protected health information. In addition to its considerable database of patients with RA, the company has also set a goal to enroll 12,000 patients into its Corrona Psoriasis Registry, a joint collaboration with the National Psoriasis Foundation, that has already surpassed 8,000 patients.
With so much information, Corrona can conduct both comparative-safety and comparative-effectiveness analyses. The company is also attempting to gain further understanding of why patients switch or discontinue medications; this may be especially relevant as biosimilars to treat RA, psoriasis, PsA, SpA and IBD hit the market.
The medical affairs component is manned by a biostats team that conducts the aforementioned comparative effectiveness research. They also conduct time-to-event analyses, create profiles of new users, and match data sets within and outside of Corrona.
As for safety, the FDA has recognized Corrona’s pharmacovigilance services. Part of this acceptance may be due to the rigorous process of adverse event reporting, confirmation and independent adjudication. The experts at Corrona believe that this process yields “scientific depth,” along with credibility for publication in peer-reviewed journals, context based on multiple comparator arms, and validation of outcome measures.
Individual Contributions
The Corrona database report that more than 24,000 RA patients were being followed in 2015, with more than half being treated with a biologic DMARD. The mean follow-up duration for these patients was 5.4 years, with a median of 4.4 years. The company notes that the “ability to query data on all products in the market space is unique to the Corrona registry.”
The registry is comprised of 180 rheumatology sites, the majority are private practice or affiliated sites. The decision-makers in the organization stress that the registries are non-exclusive, and open to new subscribers. Any current subscriber may analyze data for internal purposes or for presentation in the public domain. Once the data undergo analysis, subscribers may keep the data for internal purposes or those queries designated for the public domain are transformed into abstracts or manuscripts.
The group encourages subscribers to propose new data elements to physician and patient questionnaires, thus enabling the registries to be dynamic as the field moves forward. Questionnaires are completed at follow-up visits approximately every 6 months, and the company exercises rigorous quality control standards.
“Our questionnaires gather information on demographics, comorbid conditions, disease characteristics and adverse events,” Harrold said. “With the entry of biosimilars, our physician questionnaires have been adapted to gather information on the use of these agents. Thus, we are well positioned to examine the effectiveness and safety of biosimilars, which is critical information for practicing clinicians.”
While any qualified clinical site may collect data for Corrona, there is an approval process overseen by an Institutional Review Board. Harrold stressed that Corrona will assist with the review board process, but that each site must have a principal investigator to communicate with leaders of the registry.
“There is no limit on the number of physician extenders allowed as sub-investigators, as long as these providers are experienced in patient contact, and are judged by the PI to be qualified to complete the Provider Questionnaires,” according to the company. Once data are collected, they are entered into an electronic data capture.
Regarding payment, participating sites are compensated for data collection after submitting completed Provider and Subject Questionnaires to Corrona. Additional compensation is provided upon completion of Targeted Adverse Event forms.
Looking Ahead
Moving toward the future, there is currently open enrollment for biologic DMARDs or targeted synthetic DMARDs such as tofacitinib.
The RA registry has evolved as the management of the disease has changed, according to Harrold. “In that light, we see a number of exciting developments on the horizon,” she said. “First off, we are looking to expand our capabilities by collecting bio samples that are linked to our deep clinical data. We have experience collecting samples in our RA registry, and we have seen significant interest from both academic and industry collaborators.”
Another effort involves a pilot program for 2019 that will collect mobile patient experience data. “By collecting data on a more real time basis, we believe we will get a deeper appreciation of patient attitudes, and factors that relate to medication choice and usage,” she said.
A final piece of the puzzle is to augment existing research methods with artificial intelligence and machine learning, according to Harrold. “In so doing, we hope to gain greater value from our clinically rich data sets,” she said. “We think the future is bright, and Corrona looks forward to continuing to be a major contributor to advancing our understanding of autoimmune diseases.” —by Rob Volansky
For more information:
Leslie R. Harrold, MD, MPH, can be reached at1440 Main Street, Suite 310, Waltham, MA 02451; email: lharrold@corrona.org.
Disclosure: Harrold reports being an employee and stockholder of Corrona, LLC; receiving grant funding from Pfizer; and being a consultant to AbbVie, BMS, and Roche.