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PHEDRA: using real-world data to analyze treatment patterns and ibrutinib effectiveness in hematological malignancies
Author(s) -
Jamie Garside,
Nollaig Healy,
Hervé Besson,
Ruben Hermans,
Finlay MacDougall,
Damien Lestelle,
Joris Diels,
Wafae Iraqi
Publication year - 2017
Publication title -
journal of comparative effectiveness research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.567
H-Index - 23
eISSN - 2042-6313
pISSN - 2042-6305
DOI - 10.2217/cer-2017-0046
Subject(s) - ibrutinib , medicine , real world data , randomized controlled trial , clinical trial , oncology , medical physics , data science , leukemia , computer science , chronic lymphocytic leukemia
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.

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