MO40653: ATEZOLIZUMAB RWD IN PATIENTS TREATED IN ROUTINE PRACTICE
Research type
Research Study
Full title
A NON-INTERVENTIONAL, MULTICENTER, MULTIPLE COHORT STUDY INVESTIGATING THE OUTCOMES AND SAFETY OF ATEZOLIZUMAB UNDER REAL-WORLD CONDITIONS IN PATIENTS TREATED IN ROUTINE CLINICAL PRACTICE
IRAS ID
254786
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records.
The study aims to address the following research questions in patients treated with atezolizumab for the first time for approved indications, in the real world setting of routine clinical practice:
- What are the clinical outcomes of atezolizumab?
- What is the quality of life of patients treated with atezolizumab?
- What is the safety profile of atezolizumab?
- What is the sociodemographic and clinical profile of patients treated with atezolizumab?
- What are the characteristics of atezolizumab treatment (e.g. treatment duration, discontinuation, interruption, number of cycles)?
- What are the characteristics of prior and subsequent cancer-related therapies?
- What is the healthcare resource utilisation and associated costs of atezolizumab?
- What are the non-healthcare consequences and associated costs of atezolizumab?REC name
North of Scotland Research Ethics Committee 1
REC reference
18/NS/0145
Date of REC Opinion
20 Dec 2018
REC opinion
Favourable Opinion