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1 RWE perspec*ves Budapest 2016 March 2016
RWE Perspec,ves
“…to use pa*ent-‐centric data to derive real-‐life insights into value of medicines for individual pa*ents.”
Rients van Wijngaarden
March 2016
Budapest 2016
2 RWE perspec*ves Budapest 2016 March 2016
Outline
• What is PHARMO • Oral contracep*ves, a case study • Challenges in leveraging EHR data
4 RWE perspec*ves Budapest 2016 March 2016
What is PHARMO In-‐house Regional core databases:
• Out-‐pa*ent pharmacy • In-‐pa*ent pharmacy • General Prac**oner • Clinical laboratory
Na*onal databases: • Hospitaliza*on • Death registry
Linked databases (predefined governance)
• Na*onal perinatal registry • Na*onal pathology registry • Na*onal cancer registra*on
Incidental linked registries, such as
• Vaccina*on registry • Genera*on R • …
5 RWE perspec*ves Budapest 2016 March 2016
What is PHARMO In-‐house Regional core databases:
• Out-‐pa*ent pharmacy • In-‐pa*ent pharmacy • General Prac**oner • Clinical laboratory
Na*onal databases: • Hospitaliza*on • Death registry
Linked databases (predefined governance)
• Na*onal perinatal registry • Na*onal pathology registry • Na*onal cancer registra*on
Incidental linked registries, such as
• Vaccina*on registry • Genera*on R • …
6 RWE perspec*ves Budapest 2016 March 2016
Research area’s
• Pharmacoepidemiology • Drug U*liza*on studies • Basic Epidemiology • Post Authorisa*on Safety Studies (PASS) • Post Authorisa*on Outcomes Studies (PAOS)
7 RWE perspec*ves Budapest 2016 March 2016
Oral contracep,ves, a case study
• OC’s are widely used; exposure is huge • Side effects have been associated with OC use:
• Deep vein thrombosis • Pulmonary embolism • etc.
• However the risks are rela*vely small: • Hard to detect with RCT’s • Large datasets from daily prac*ce needed
8 RWE perspec*ves Budapest 2016 March 2016
Oral contracep,ves, a case study
• Perform a mul*-‐database study • 4 databases selected:
• IPCI and PHARMO in the Netherlands • THIN in the UK • HSD in Italy
• Results published: Bezemer ID, Verhamme KM, Gini R, Mosseveld M, Rijnbeek PR, Trifiro G, et al. Use of oral contracep*ves in three European countries: a popula*on-‐based mul*-‐database study. The European journal of contracep6on & reproduc6ve health care. 2015:1-‐7.
10 RWE perspec*ves Budapest 2016 March 2016
Oral contracep,ves, a case study
• Where do these differences come from? • Prescrip*on vs dispensing (ie. resupply strategy) • Prescribed by specialists
• Why only 4 databases? • Oral contracep*ves are only partly reimbursed • Therefore not captured in many databases
11 RWE perspec*ves Budapest 2016 March 2016
Challenges in leveraging EHR data • Even if:
• Mapped to a Common Data Model • Seman*c interoperability • Results are meaningless without context
• We have to deal with constraints • What is captured? • How/why is it captured? • What is not captured?
• Constraints can change over *me • There is no ‘one size fits all’
13 RWE perspec*ves Budapest 2016 March 2016
Challenges in leveraging EHR data
• What is needed? • Feasability assesment
– Is the event/drug of interest properly captured? – Is there a ‘gold standard’ available?
• Expert knowledge – A solid understanding of what is captured, why and by whom
• Collabora*on – Get a feeling for what is missing