One major gap blocking the advancement of sarcoidosis research is a lack of PATIENT DATA. Research would benefit from a repository of a longitudinal large sampling of sarcoidosis patient data, and to address this gap, FSR hosts a patient-outcomes registry, the FSR-SARC (Sarcoidosis Advanced Registry Cures).
FSR-SARC is an IRB-approved collection of longitudinal patient data via our on-line state-of-the art patient registry tool, a HIPAA-compliant hosting facility that provides a secure environment to protect properly consented de-identified patient information. The registry is designed as an extensive online-based questionnaire that allows for patient and/or patients’ caretakers to enter information on patient demographics, medical history, familial history, organ-specific disease details, treatment history, and elements that indicate the burden of the disease on the patient’s quality of life.
The registry is a longitudinal web-based patient registry allowing patients to complete comprehensive registration providing history, medical reports, diagnostic information, and updates. This data will be made available to researchers via a data-sharing process for pharma and researchers to access raw and queried data. The objectives of the FSR Patient Registry are to:
- Stimulate hypothesis-driven clinical research and new drug development among academic and industry partners by making available a large longitudinal set of aggregated de-identified data on sarcoidosis patients interested in participating in clinical trials;
- Enhance the understanding of the variability, progression, and natural history of sarcoidosis with the ultimate goal of better guiding and assessing therapeutic intervention;
- Provide the sarcoidosis medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care;
- Connect interested patients to IRB-approved research opportunities.
Initially partnering with the National Institutes of Health within their pilot study, the Global Rare Disease Repository, FSR constructed the patient registry designed to collect extensive longitudinal data on sarcoidosis patients to resource sarcoidosis research stakeholders including researchers, physicians, healthcare providers, and pharma and biotech industries. Currently at nearly 3000 patients, FSR seeks to recruit thousands more on a global level. FSR has developed an extensive recruitment plan designed to educate patients worldwide about the need for the registry and its data; encourage and train them to enter their data; and to guide them in ongoing updates to the longitudinal data entries.
It is comprised of nearly 100 questions collaboratively developed by the FSR Scientific Advisory Board. It is accessible to patients through the FSR website, although hosted on a contracted third-party highly secured platform. The outreach is global; while currently provided in English, the registry will soon expand to other languages.
FSR will manage data queries for researchers, as well as completing internal data analysis and publication. Researchers will be able to apply for access data via an online application system for FSR approval process.
Researchers who wish to request registry data for observational studies can complete the formal application and confidentiality-usage agreement below. The application includes instructions regarding the format of the applications, regulatory requirements and other responsibilities for individuals receiving registry data. Variables included in the registry also are available in the link to questionnaire below. If you have any questions please contact us at firstname.lastname@example.org.
Applications will be granted based on strength of validity and purpose by the FSR SAB – Patient Registry Committee.
- Questionnaire – all survey questions asked of participants
- FSR Patient Registry Data Application and Confidentiality-Usage Agreement