Observational study of EPR and HCRU in first line NSCLC patients
Research type
Research Study
Full title
Observational study of treatment patterns, healthcare resource utilisation, costs and outcomes among adult advanced non-small cell lung cancer patients who received first-line therapy in the UK
IRAS ID
250924
Contact name
Jason Lester
Contact email
Sponsor organisation
Merck Serono Ltd
Duration of Study in the UK
0 years, 7 months, 27 days
Research summary
Lung cancer is the commonest cause of cancer-related death in the UK. There are two main types: Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC). NSCLC represents approximately 87% of all lung cancers in the UK.
Over the last 5 years, multiple therapies have been developed to target certain tumour mutations. The aim of this study is to assess patient’s characteristics, treatment patterns, outcomes and healthcare resource utilisation for advanced NSCLC patients who receive first-line treatment in the UK. The study will generate real-world data on treatment assignment, duration of treatment, time to next treatment and response using electronic prescribing records (EPRs) and patient notes. The study will also generate healthcare resource utilisation (HCRU) data (which looks at hospital admissions, duration of stay, treatment procedures, costs) using hospital episode statistics (HES)for lung cancer patients on first-line treatment. The importance of understanding these outcomes in real-world is to support future submissions of new treatments.
The EPR and patient notes part of the study will be conducted as a multicentre, retrospective, observational study. The study will collect retrospective EPR data from up to 1000 patients across 10-15 NHS sites (England, Wales and Scotland). All patients with advanced NSCLC who received a first-line treatment from June 2016 to March 2018 will be included (unless they have participated in an interventional clinical trial). Data collection will start in February 2019 until May 2019.
For the HES analyses, it will include all patients with metastatic lung cancer who received a first-line treatment from November 2016 to December 2017. Each patient will be followed up for a minimum of 12 months from start of their first-line treatment. HES analysis includes all patients in NHS England Trusts.
Merck Serono Limited are the sponsors for the study.REC name
London - Bromley Research Ethics Committee
REC reference
18/LO/2179
Date of REC Opinion
31 Dec 2018
REC opinion
Favourable Opinion