Retrospective review of current treatment pathways for MF in the UK
Research type
Research Study
Full title
REALISM UK: Retrospective real world evidence to review the current treatment pathways for myelofibrosis from across the UK
IRAS ID
236800
Contact name
Adam Mead
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
Myelofibrosis is a disorder of the bone marrow that affects the normal production of blood cells. Myelofibrosis causes symptoms of low blood cell counts (of particular blood cell types), enlarged spleen, tiredness, weakness, tummy pain, weight loss, itching, night sweats, and bone pain. There are a multitude of treatment options for the management of myelofibrosis and treatment can be very heterogeneous. There are currently limited “real world” data on the treatment and management pathways for patients with myelofibrosis specifically from the UK. This study aims to provide insights to address this gap in knowledge by documenting the routine clinical pathways for treatment and management of patients with myelofibrosis in the UK. It will also document the frequency and outcomes of events of special interest in these patients.
This is an observational, retrospective, multi-centre descriptive research study. There will be no changes to patient management for the purposes of any part of the study. The target study group will be patients diagnosed with myelofibrosis in the last five years. The study will take place across 10 – 15 UK NHS hospitals (secondary and tertiary care centres) with a target sample size of 200 – 250 patients.
Retrospective data will be collected from patients’ medical records by trained data collectors. All living patients will be invited to consent to allow a researcher access to their medical records for the purpose of data collection. Since no consent can be obtained where the patient is deceased and contacting the relatives of deceased patients is likely to cause distress, members of the direct care team will collect the data from identifiable records and provide anonymised data to researchers for analysis.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0425
Date of REC Opinion
13 Nov 2017
REC opinion
Further Information Favourable Opinion