GloBE-Reg
Research type
Research Database
IRAS ID
314283
Contact name
S. Faisal Ahmed
Contact email
Research summary
Global Registry For Novel Therapies In Rare Bone & Endocrine Conditions
REC name
West of Scotland REC 4
REC reference
22/WS/0074
Date of REC Opinion
26 Jul 2022
REC opinion
Further Information Favourable Opinion
Data collection arrangements
All data shall be stored on secure servers in the University of Glasgow and will be kept strictly confidential and all information will be handled through very secure electronic systems. The Registry users will not be able to make contact any patient because the name, address and hospital number will not be recorded. Only the hospital doctor and their team will be able to contact the patient as they can link the data in the Registry to the hospital records. To access the data from the Registry, investigators will need to apply to the Data Access Committee and once the application has been approved, the data shall be provided to the investigators with strict data sharing agreement. The provision of data will also occur through secure electronic systems rather than just by email. Again, the data that are provided will not contain any information that can allow the investigator to link the information to the actual patient. A progress report will be obtained every year to understand the research progress of the investigators.
Research programme
GloBE-Reg has been developed with the needs of people with rare endocrine conditions who are starting on new therapies in mind. The initial focus is on children and especially a group of children who are starting on a drug called growth hormone (GH). There are currently no international registries for children starting GH therapy that are independent of industry. The registries that exist are limited to one region, or limited for specific conditions or run by individual companies. GloBE-Reg intends to develop one single registry for all children receiving GH. This approach has been welcomed by patients, doctors, industry as well as the regulators who monitor the use of these drugs. However, if the registry works well, then the platform can be used for other endocrine therapies in children as well as adults.
Research database title
Global Registry For Novel Therapies In Rare Bone & Endocrine Conditions
Establishment organisation
The University of Glasgow
Establishment organisation address
IT Services
Sir James Black Building
G12 8QQ