Thursday, 7 April 2016

Real World Evidence in Drug Development

Chris Chinn -Sanofi 

Acceptability of real world evidence
R-D decision anticipate the HTA decision
phase 3 optimise
phase 3b supplement
conditional licensing
conditional access
phase IV

Would we accept the uncertain for a period of time while waiting for the study to complete?

R-D decision
to what extend  generate the study plan generate data for effectiveness?
the concern of pharma/producer of health technology : will the study be accepted by regulators and HTA agencies?

IMI Get real Work Packages
understading the efficacy-effectiveness gap
clinical design barriers
best practices-predictive models
practical feasibility

Questions asked at workshop of Pragmatic Design of Clinical Trials

Get Real deliverables

Raising acceptability

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