PACIFIC-Real World
Research type
Research Study
Full title
First real-world data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy
IRAS ID
258923
Contact name
Fiona McDonald
Contact email
Sponsor organisation
AstraZeneca
Clinicaltrials.gov Identifier
NCT03798535, ClinicalTrials.gov Identifier
Duration of Study in the UK
5 years, 4 months, 1 days
Research summary
This is an observational study conducted in several countries within the European Union.
Participation in the study will not change the prescription or intake of any
medication the patients are receiving in their routine treatment. There are no physical risks associated with participation in this study. This study is designed to collect information and does not require any change to treatments or therapies beyond what the patient already receive (normal care).
The need to assess the effectiveness of durvalumab in patients treated in real-life settings by evaluating disease progression and following the regimen type.
Each patient must be capable of providing informed consent, based on the opinion of the study doctor, which must be documented before study data collection. Patients must sign a participation agreement/informed consent form (ICF)
before any study-related documentation is performed, indicating that they understand the purpose of the study and that they agree for their data to be collected and analyzed, with source data verification, in accordance with local
requirements.
A Next-of-Kin Informed Consent Form will be introduced for the collection of clinical data pertaining to a deceased kin(referred as ''ward''). There will be no direct benefit to the ward in this study, but the collected information may help other people in the future. Including ward in this study is voluntarily. Prior the ward inclusion in the study, next-of-kin will be required to read and sing this Informed Consent Form. The study doctor will abstract data relevant to the study from ward's medical dossier at his/her inclusion in the study. Ward's personal information could be sent to countries outside of the European Economic Area(EEA), however personal information will be kept completely private, no matter which county it goes to, even if that country does not have the same level of protection for personal information as United Kingdom. No payments will be received for consenting or data collection from ward in the study.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
19/NE/0128
Date of REC Opinion
15 Apr 2019
REC opinion
Unfavourable Opinion