We will review in detail the types of Real World Data (RWD) sources available in the US, Europe and Asia, both proprietary and government-sourced, that can be leveraged to inform trial design and execution.
TPPs and CDPs – Country-level incidence/prevalence and treatment rates can now be calculated real-time using a combination of medical claims, EMR, and longitudinal prescription data.
Addressable patient population for a trial: once a protocol is defined, one can produce attrition tables that can filter these large data sets with the relevant inclusion & exclusion criteria. This can offer an accurate estimate of the likely available patient population for the trial.
Other insights: RWD can also be leveraged to refine country and site selection. In this presentation, we will provide examples of this type of work in several countries, for several conditions. We will also give some insights on how the regulatory bodies are beginning to accept RWD as evidence in clinical trials.
Understand the types of Real World Data available in the US and ex-US
Understand how these can be used for the development of TPPs and CDPs, and protocol assessment
Understand how these can be used to refine country and site selection
Senior Principal, Strategic Drug Development,
Webinar Replay: How Can Real World Data Improve the Early Clinical Development Process? Exam
1.00 - ACRP Credits
1.00 - CME Credits
1.00 - CNE Credits
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5/1/19 8:18 pm
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