The GRDR will establish a common data repository for studying rare disease by aggregating patient information from multiple registries based on a library of common data elements. By including any participating registry, the repository enables cross-disorder analysis which may result in non-obvious research correlations as well as providing a larger patient population for recruiting into trials.
How it Works
De-identified data from participating patient registries is aggregated into the GRDR repository. Interested researchers and investigators can apply to gain access to the repository. Once approved, an investigator will have the ability to query the data to find subsets of patients who may be potential candidates to receive clinical trial or study recruitment information. Researchers can also receive patient counts and data by submitting requests to the registry coordinator. Investigators can use the repository to inform registered families of the latest research findings. Explore other examples of how respository data can be used.
Registries are sponsored by patient organizations that function as the trusted gatekeepers to the patient participants. An investigator who wishes to share information with patients can do so by contacting the sponsoring patient registry, which in turn sends information to the participants. Response rates and recruitment into trials are more effective when the trusted patient gatekeepers send the emails on behalf of researchers. This results in highly targeted and effective recruitment efforts that protect the privacy of participating patients.
Data for Research Purposes
Approved research investigators can query and access de-identified patient data from one or more contributing registries for analysis, study planning, feasibility assessments and other research learnings. The data available to researchers will be based on the CDEs adopted by the GRDR and will be collected in a longitudinal manner. Individual registries may collect additional data beyond the core CDEs. Research investigators seeking additional data will be encouraged to contact the GRDR and the sponsoring registry for further information.
At the time of registration, patients may elect to receive announcements regarding research developments or other relevant news and findings. Participants in the target audience who have opted to receive relevant information are contacted by the registry coordinators. In these communications, patients are provided a method to request more information through the registry. Notices will be reviewed and approved by the registry team before being distributed.
Clinical Trial and Study Recruitment
Through the GRDR infrastructure, clinical investigators can search multiple sources in one application to identify those patients that may be valid candidates for inclusion in clinical trials or studies.
Investigators who wish to use the GRDR to reach screened participants will be asked to provide detailed information about their IRB, purpose for accessing the data or details as appropriate, and the study notice they would like sent to registry participants. Upon approval, the study notices will be emailed to willing participants who meet specified inclusion/exclusion criteria. All study notices will come from the registry with links to the researcher’s recruitment site, as applicable. In these communications, patients are provided a method to request more information from the study investigators through the registry. The notice may also be posted on the registry website. Each communication sent to a patient is recorded in an audit trail and tracked for effectiveness reporting.
Additional details will be available for interested investigators as the repository is further developed.
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