Real World Evidence in Lung Cancer
Research type
Research Study
Full title
Real World Evidence in Lung Cancer
IRAS ID
172597
Contact name
Richard Steyn
Contact email
Sponsor organisation
Heart of England NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The purpose of this study is to identify opportunities to improve patient outcomes and healthcare system efficiency through the use of a real world data. Specifically, we are seeking to use pseudonymised routinely collected data to build a data driven description of actual patient pathways across primary, secondary and community care. These data will be analysed to identify opportunities to improve care and to demonstrate the potential impact of such improvement: by identifying variations: in how patients engage with the healthcare system, and in outcomes (including under served patient groups); by measuring the effectiveness of current interventions; by identifying opportunities to improve care co-ordination; and by identifying variations against current best practice pathways.
The therapeutic area focus of this study will be Lung Cancer, building upon an already-approved proof-of-concept study relating to the diabetes therapeutic area (reference number: 15/LO/0623). This submission only refers to the Lung Cancer study. Any further extension of the scope of the study to additional therapeutic areas will be covered under a separate Ethics review submission.
We will achieve our aims by constructing a technological platform to link pseudonymised clinical and administrative data across primary, secondary, and community care for our studied cohorts. We plan to undertake an extract of retrospective data in Mid/Late-2015 – whilst the length of that dataset will vary depending on historic IT systems, we hope to collect around 10 years of data. We will seek to refresh the dataset on a regular basis in order to both extend the length of the dataset and also to ensure it remains in line with treatment practice – our current expectation is to refresh the dataset on a quarterly basis over a time period of one year.
This will be governed in line with strict information governance agreements with each participating NHS institution and by substantial national policy and legislation. Furthermore, a cross-institution Governance Board including clinical, managerial and patient representatives will ensure questions are appropriate and balance the interests of the parties without compromising patient benefit. The Governance Board will review and approve all the analyses to be conducted as part of the study.
Findings will be used by Heart of England NHS Foundation Trust (HEFT), Birmingham Cross City CCG, Solihull CCG and Birmingham Community Healthcare Trust to improve care provision. Where possible findings will be published in peer reviewed academic journals to ensure the outcomes of this research can have broader patient benefit both within the NHS and elsewhere.
REC name
North of Scotland Research Ethics Committee 2
REC reference
15/NS/0116
Date of REC Opinion
27 Oct 2015
REC opinion
Favourable Opinion