Edinburgh Clinical Trials

Eribulin Audit

Post-adoption surveillance audit of new medicines for metastatic breast cancer in the real world

Eribulin is a new cytotoxic chemotherapy drug approved by the Scottish Medicine Consortium (SMC) in 2016 for the palliative treatment of advanced breast cancer in patients previously treated with an anthracycline, a taxane, and capecitabine. There is some evidence of higher efficacy in certain molecular subgroups, such as those with triple negative breast cancer. The evaluation of effectiveness and cost-effectiveness, however, poses a challenge because of uncertainties about the place of eribulin in the treatment pathway but also outcomes, patient characteristics, impact of toxicity and service impact within a real-world setting.

 

Scotland has a wealth of administrative datasets but such data is not currently exploited for post-marketing surveillance. The aim of this audit is to assess the robustness of this administrative data in relation to real-world clinical outcomes and the cost-effectiveness of eribulin specifically. We also hope to evaluate the suitability of using this data for the assessment of new medicines required as the basis of national decisions on the adoption of other new drugs.

 

Chief Investigator: Dr Peter Hall

Geographical scope: Scottish National data

Funder: Eisai Europe Limited

Start and End date

Of grant award: December 2021

 

Status: Data Acquisition, Data Analysis

 

Sponsor: University of Edinburgh/NHS Lothian – Academic and Clinical Central Office for Research and Development http://www.accord.ed.ac.uk/

Chief Investigator: Dr Peter Hall

Project Manager: Dr Holly Ennis

 

GDPR privacy statement: Yes

 

ECTU Involvement: Health Economics