Corrona, LLC
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Southborough, Massachusetts, US
Corrona is a real world evidence business providing registry data and consulting services to biopharmaceutical companies. Our clients face major challenges to demonstrate the health outcomes of their drugs. This may be achieved through legislative and regulatory-mandated pathways (e.g., post-approval surveillance requirements, REMS programs, pharmacovigilance plans), by analyzing comparative effectiveness data to generate potential new claims, or measuring health outcomes to justify the value of the drug to payers.
The Corrona model for data collection involves developing and sustaining a robust network of affiliate clinical sites, both academic and private, which contribute data from both physicians and patients. The sites are compensated for their data collection and submission efforts. All research programs are conducted under the oversight of a contracted Institutional Review Board or other local authority (e.g., an academic site). The data that are collected from the sites undergoes quality control for accuracy and completeness, and is stored in a secure data warehouse for access by Corrona biostatisticians and epidemiologists.
Corrona is an independent registry without any ownership links to the pharmaceutical industry.
Selected Publications
Abstract
BACKGROUND:
Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA).
METHODS/DESIGN:
CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced).
DISCUSSION:
The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA.
Abstract
BACKGROUND:
Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA).
METHODS/DESIGN:
CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced).
DISCUSSION:
The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA.
BMC Musculoskelet Disord. 2014 Apr 1;15:113. doi: 10.1186/1471-2474-15-113.
Abstract
BACKGROUND:
Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA).
METHODS/DESIGN:
CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced).
DISCUSSION:
The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA.
BMC Musculoskelet Disord. 2014 Apr 1;15:113. doi: 10.1186/1471-2474-15-113.
BACKGROUND:
Comparative effectiveness research has recently attracted considerable attention. The Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) is an ongoing prospective cohort study of adult patients with Rheumatoid Arthritis (RA).
METHODS/DESIGN:
CERTAIN uses the existing Consortium of Rheumatology Researchers of North America (CORRONA) network of participating private and academic sites in order to recruit patients fulfilling the 1987 ACR criteria that have at least moderate disease activity. Patients starting or switching biologic agents either anti-TNF therapy or a non anti-TNF biologic are eligible for enrollment, depending on the treatment selected by their physician. Enrollment is expected to be completed by March of 2014, and 2711 patients will participate in the study. As of October 7th 2013, 2234 patients have been enrolled. Patient visits and laboratory blood work are mandated every three months for one year. Safety data is collected through one year and beyond. The primary comparative effectiveness endpoint is attainment of low RA disease activity at one year among patients who have been exposed to at least one prior TNF-α inhibitor agent prior to enrollment. Multiple secondary effectiveness and safety endpoints will be addressed by investigating the entire population enrolled (naïve and biologic experienced).
DISCUSSION:
The unique design features of CERTAIN will inform comparative effectiveness and safety questions for choosing biologic agents for the management of RA.
A key initial focus of our commercial work is linking our deep clinical data to claims and related data sets, based on the HIPAA-compliant protected health information (PHI) we have on approximately 10,000 rheumatoid arthritis (RA) patients.
We will be expanding our linkage work to psoriasis (PSO) in the future (where we expect to have approximately 10,000 patients with PHI as well). The deep clinical data collected longitudinally in a standardized format we believe is highly relevant for commercial executives.
Combining registry and claims data allows us to generate insight in several areas, for example:
We are building a suite of offerings in the commercial space, some of which rely on linked data, and others that are based solely on the deep clinical data.
Real World Performance Dashboard
Combining claims and Corrona data to generate unique insights for clients, including high level metrics on cost effectiveness, adherence and persistence, market penetration, outcomes, and safety reports specific to their drug.
Reasons for Therapy Switch
Monthly dashboard that looks at the reasons why patients have discontinued their therapy – including up to 16 reasons why a patient discontinued medication.
Biosimilars Dashboard
Up to 18 biosimilars will launch in the 2016 – 2018 time frame in RA, PSO, PsA/SpA, and IBD. The performance of these drugs is of intense interest to all branded products. Corrona data can provide insights on reason for switch, characteristics of what patient segments are switching and why. With monthly updates, Companies can do near real time searching for insights.
Patient Segmentation/Patient Journey
Corrona’s deep clinical data, with clinically validated outcomes and longitudinal history, are superior to market research. We plan to link to claims data for greater insights. Our analyses can analyze all responses by tiered disease activity metrics, providing a unique patient segmentation not available from any other source.
Our pharmacovigilance services are accepted by FDA and tailored to the needs of each client.
Our Approach
Advantages
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