SOLTI-2508 REWIND
Real World Evidence Program
A framework-study for conducting REal-World Evidence (RWE) INvestigation in breast cancer Disease
Status
Tumour subtype:
Scenario
SPONSOR
SOLTI
COLLABORATORS
PRINCIPAL INVESTIGATORS
Dra. Meritxell Bellet
Hospital Universitari Vall d'Hebron, Barcelona
Dr. Juan Miguel Cejalvo
Hospital Clínico Universitario de Valencia
This study aims to address the following overarching research question: What are the clinical characteristics, treatment patterns, healthcare resource utilization, and outcomes of patients diagnosed with breast cancer in real-world settings across Spain?
By addressing this question, the study seeks to understand how breast cancer is managed in routine clinical practice in Spain, identify potential variations in care, and generate insights that may inform healthcare policy, clinical guidelines, and patient-centered care models.
Methodologically, this project will use information previously collected during routine clinical practice. Every aspect of this project will be undertaken by staff within a care team using information previously collected during care for their patients. The quality of the information will be centrally monitored by SOLTI group.
The primary data sources are expected to be electronic health records, pharmacy records, clinical histories and other patient hospital records.
The study data are collected in pseudonymized format and processed exclusively for scientific purposes, in accordance with Regulation (EU) 2016/679 (GDPR) and Organic Law 3/2018, on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD).
The data will be retained for 25 years in accordance with biomedical research regulations. SOLTI and the participating healthcare centers, each within their respective areas of responsibility, are responsible for data processing.
In compliance with Additional Provision 17 of the LOPDGDD, an exemption from informed consent has been requested. Furthermore, a Data Protection Impact Assessment and a Legitimate Interest Assessment have been carried out, which support the lawfulness, necessity, and proportionality of the processing in the context of this study.
Interested parties may exercise their rights of access, rectification, erasure, limitation of processing or opposition, through the following email address: protecciondedatos@gruposolti.org
