Dabrafenib Metastatic Melanoma Chart Review (DESCRIBE)
Research type
Research Study
Full title
Dabrafenib Metastatic Melanoma Name Patient Programme Retrospective Chart Review
IRAS ID
142698
Contact name
Ewan Brown
Contact email
Sponsor organisation
GSK
Research summary
This is an observational retrospective chart review study of treatment patterns and clinical and safety outcomes in subset of patients with unresectable and metastatic melanoma who received dabrafenib as part of the NPP.
This study requires no intervention or interference with standard medical care, and thus it will not affect patient treatment.
Charts of patients who received at least one dose of dabrafenib as part of the NPP between 1 December 2010 and 1 August 2013 will be identified by site staff. Each identified patient will be assigned a pre-formatted unique study identification number. Site staff will review the medical charts for all identified patients to determine patient eligibility. Those patients who meet eligibility criteria will be enrolled into the final study cohort as subjects. Pseudonymised data (anonymous to non-site staff) from subjects’ medical charts will be abstracted by site study staff and entered at the site into the electronic data capture (EDC) system.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1962
Date of REC Opinion
25 Feb 2014
REC opinion
Further Information Favourable Opinion