Demonstrating the feasibility of collecting secondary, de-identified data on Australian patients receiving treatment as part of a Medicine Access Programme
Sheau W Lok, Richard De Boer, Cassandra Cordwell, Gavin Marx, Peter Fox, Csilla Hasovits, Joseph Rutovitz, Michael Harold, Ben Tran, Hui-Li Wong, Peter Gibbs
Internal Medicine Journal | WILEY | Published : 2020
BACKGROUND: In Australia, data generated from the carefully selected, treated and monitored patients enrolled in clinical trials largely inform routine care and funding approvals. Medicine Access Programs (MAPs) enable drug access and whilst potentially a rich source of data, historically have not collected data beyond a participant list. AIMS: To explore the feasibility of using MAPs to identify patient populations for inclusion in non-interventional studies. METHODS: Clinicians affiliated with the Walter and Eliza Hall Institute (WEHI) engaged with Roche to implement PeRSIA, a secondary data use non-interventional study of patients receiving neoadjuvant pertuzumab for non-metastatic HER2+ ..View full abstract
The PeRSIA study is sponsored by Roche Products Pty Limited.