Real-world effectiveness of dabrafenib and trametinib in patients with BRAF-positive melanoma treated in routine Bulgarian clinical practice

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000567
• EU PAS number:
  EUPAS1000000567
• Study ID:
  1000000567
• Official title and acronym:
  Real-world effectiveness of dabrafenib and trametinib in patients with BRAF-positive melanoma treated in routine Bulgarian clinical practice
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria
• Study description:
  Real-World Data Analysis of BRAF-Targeted Melanoma Therapy Compared to Clinical Trials Using Danny Platform;
• Study status:
  Finalised

Research institutions and networks

Institutions

Sqilline Health

Bulgaria

The Bulgarian National Council on Prices and Reimbursement of Medicinal Products (NCPRMP)

Study timelines

Date when funding contract was signed

Planned: 20/03/2023

Actual: 20/03/2023

Study start date

Planned: 01/01/2018

Actual: 01/01/2018

Data analysis start date

Planned: 07/09/2023

Actual: 07/09/2023

Date of final study report

Planned: 18/12/2024

Actual: 18/12/2024

Sources of funding

No external funding

Study protocol

Real-world effectiveness of dabrafenib and trametinib in patients with BRAF-positive melanoma treated in routine Bulgarian clinical practice

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable