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Describing the clinical characteristics, treatment patterns and outcomes in early breast cancer patients meeting the MonarchE clinical trial criteria for high risk of recurrence using real world data.

Safe People

Organisation name

University of Edinburgh

Applicant name(s)

Dr Mahéva Vallet

Funders/ Sponsors

Eli Lilly

Safe Projects

Project ID

DL_2022_030

Lay summary

New medicines are in development that may reduce the risk of cancer recurrence and improve survival after treatment for early breast cancer. NHS cancer services in Leeds and Edinburgh need strong evidence on the of the current quality of care prior to adopting new treatments for their patients that may risk disrupting this quality. ​While clinical trials can provide much of this evidence, there is also a need to provide evidence on the current ‘real-world’ patient population, standard treatments and current outcomes that are considered quality metrics in the patient populations serviced by the current cancer service provided by the NHS in Edinburgh and Leeds. ​The project will generate a description of the current early breast cancer patient pathway in Leeds and Edinburgh. The anonymised Leeds data will be sent to Edinburgh for analysis. The analysis takes place within the NHS by NHS staff, with only a summary report that does not contain individual patient data being released for use by NHS cancer services. This project is an extension of a previous service evaluation undertaken in NHS Lothian only. ​The project output will enable the NHS to make better informed decisions on the place of future medicines to ensure the NHS is providing high quality care to the patients it serves.

Public benefit statement

New medicines are in development that may reduce the risk of cancer recurrence and improve survival after treatment for eBC. NHS cancer services need strong evidence on the safety, efficacy, effectiveness and cost-effectiveness of new treatments prior to approving medicines as standard care reimbursed by the NHS if they are to maintain quality of care. ​While clinical trials can provide much of this evidence, there is also a need to provide evidence on the current ‘real-world’ patient population, standard treatments and current outcomes. This evidence is essential for NHS services to understand how the quality of care that they currently provide might be affected by the future introduction of new medicines. ​Such evidence can only be generated by the ‘service evaluation’ of routine NHS care. Electronic Health Records are now sufficiently robust to enable such analysis. Since the NHS in Scotland and England relies on drug manufactures to submit evidence on current services for the appraisal of new medicines a mechanism is required for companies to commission the necessary analysis and generate a suitable real world evidence as an essential component of their submissions to the NHS. Without this evidence the NHS is unable to make a robust assessment of the value of new medicines and how they may affect the quality of services. ​A real-world data collaboration between study Eli Lilly and NHS Lothian was performed in 2021, this was a service evaluation with the main objective to describe the patient profile, demographics and clinical characteristics of early breast cancer patients in South-East Scotland by risk status. This is a proposal for Leeds Teaching Hospitals Trust (LTHT) and the Edinburgh Cancer Centre (NHS Lothian), to analyse data that are routinely collected during the treatment of breast cancer patients as part of current services, thereby enabling a description of the current treatment and outcomes experienced by patients. It will also tell us which patients are treated by the service with which treatments with respect to patient selection , thus characterising the patient population who are now eligible for adjuvant abemaciclib per the MHRA license. The evaluation will provide insight useful for maintaining the quality of care as part of the adoption of the drug by NHS services in Leeds and Edinburgh, such as clarifying the size of the eligible population and their current treatment and clinical pathway details and outcomes that they measure.

Request category type

Other

Latest approval date

12/04/2023

Safe Data

Dataset(s) name
Data sensitivity level

Anonymous

Safe Setting

Access type

Release