August 2026Recommendations for generating real-world evidence with regulatory-grade relevance and reliabilityReal-World EvidencePublication summaryPublicationsRegulatory
April 2026External control arm feasibility across external data sources in oncology: methodological and regulatory science considerationsTrial designRegulatory
March 2026RWE Submission for European Regulators and Payers: Challenges, Uncertainties, and OpportunitiesRegulatory
February 2026A feasibility analysis to align fit-for-purpose real-world data to emulate the AZUR-1single-arm clinical trial in patients with dMMR/MSI-H locally advanced rectal cancerPrecision medicineColorectal cancerRegulatory
December 2025Utilization of real-world evidence in regulatory approvals for multiple myeloma therapiesRegulatoryHematologic malignancies
October 2025Fit-for-purpose real-world data: Lessons from FDA QCARD and EMA Data Quality FrameworkRegulatory
July 2025Crossing borders: the need for empirical evidence of real-world evidence transportability in oncologyComparative effectivenessRegulatory
April 2025From data to decisions: the role of real-world evidence in recent multiple myeloma drug approvals in the US and EURegulatoryReal-World Data
February 2025Characterisation of oncology EHR-derived real-world data in the UK, Germany, and JapanMethodologyRegulatoryReal-World Data