TREAT-NMD patient registries - for industry and researchers
The primary purpose of the TREAT-NMD global registry is to allow pharmaceutical companies and other researchers to gain access to cohorts of patients in a manner that is as rapid and streamlined as possible for the researcher whilst still providing adequate data protection for the patient.
Access to encrypted data stored in the global TREAT-NMD registry can be granted to researchers and pharmaceutical companies for the planning of clinical trials and for other research purposes such as epidemiological studies. Third parties will not be given direct access to patients or identifiable data. Instead, their request will be transmitted to the patients via the TREAT-NMD global and national registry system.
A full description of the system for access to patient data from the registries is in preparation and will appear here in the near future together with a data request form. In brief, the system will work as follows:
- Third parties requesting access to registry data for the purposes of multinational clinical trials must do so via the TREAT-NMD global registry, not through the individual national registries.
- Access will only be granted if third parties can provide evidence that their study has already received appropriate ethics approval (institutional review board).
- The study will then be reviewed by the TREAT-NMD global database oversight committee (GDOC), who will verify that the study is not in conflict with TREAT-NMD goals and will approve requests within a set time period.
- The TREAT-NMD GDOC is composed of representatives of the TREAT-NMD network (leader of the workpackage on patient registries; Clinical Trial Coordination Centre; Ethics Council and certain partner organizations) plus representatives of patient organisations and national registries. It is chaired by the TREAT-NMD activity leader.
TREAT-NMD will negotiate with third parties on behalf of the national registries. A fee structure for such services will be developed by the TREAT-NMD global database oversight committee and approved by the TREAT-NMD Governing Board and national registries, and will be reviewed on a regular basis.
For more information, please refer to the TREAT-NMD Registries Charter or contact Professor Hanns Lochmüller.
Access to data in the global TREAT-NMD registry will be possible within the coming months. To find out which countries are setting up registries, please click here.
