PHEDRA: using real-world data to analyze treatment patterns and ibrutinib effectiveness in hematological malignancies. (January 2018)

• Record Type: Journal Article
• Authors: Garside, Jamie; Healy, Nollaig; Besson, Hervé; Hermans, Ruben; MacDougall, Finlay; Lestelle, Damien; Diels, Joris; Iraqi, Wafae
• Is Part Of: Journal of comparative effectiveness research. Volume 7:Number 1(2018)
• Page Start: 29
• Page End: 38
• Publication Date: 2018-01
• Subjects: comparative effectiveness research -- hematology -- methodology; Medical care -- Research -- Periodicals; Medical care -- Research -- Evaluation -- Periodicals; Medical care -- Decision making -- Periodicals; Evidence-based medicine -- Periodicals; Medicine, Comparative -- Periodicals; 362.1072
• DOI: 10.2217/cer-2017-0046
• Languages: English
• ISSNs: 2042-6305

Abstract

Aim: PHEDRA (Platform for Haematology in EMEA: Data for Real World Analysis) is a unique, noninterventional project based on secondary data collection from real-world (RW) patient-level (health record) databases to understand treatment patterns in hematological malignancies. It compares ibrutinib's effectiveness with alternative treatments using RW data (RWD) and randomized clinical trials data.Materials & methods: RWD are cleaned, validated, harmonized into a Common Data Model, and analyzed statistically alongside randomized clinical trial data. Treatment outcomes include overall and progression-free survival.Results: To date, RWD (four databases) are available for 2840 patients in three indications, collected between 1990 and 2017.Conclusion: PHEDRA is an innovative approach to generate evidence to inform optimal treatment decisions in RW settings.