Current and Future Use of Real-World Data

Peter Malamis; Michael Joseph Howley Jr

As the clinical trials industry prepares for the final FDA guidelines on real-world data,* executives must consider how their organizations should invest in real-world data going forward.1 The COVID-19 pandemic has illustrated both the benefits and drawbacks of real-world data, accentuating the need for more information about how organizations should invest in these capabilities. The decision to invest in real-world data is complex. Enthusiasts point to the benefits of real-world data, including the availability, efficiency, and generalizability.2,3,4,5,6 Skeptics of real-world data counter with the still uncertain regulatory environment and cite concerns about the quality, validity, reliability, relevance, costs, and provenance of the data.1,5,7 At the same time, the stakes are getting higher on these real-world data investment decisions; data is getting more expensive to acquire, curate, and protect.+ Achieving a positive return-on-data in this environment demands multi-functional collaboration on the use of the data across silos. The first purpose of this research is to describe the overall current and future usage of real-world data. Real-world data usage is assessed within each of the functional areas (e.g. corporate strategy, trial design, site selection, or FDA submission) and then averaged into an overall usage score to get a view of how real-world data is being used across silos. We then examine the factors that drive real world data usage in two areas—the actual data as well as the data intermediaries/software providing that generate information from the data. The results of this analysis will help clinical trials make rational investments in real-world data.

Current and Future Use of Real-World Data

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Abstract

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Current and Future Use of Real-World Data

Files and links (1)

Abstract

Metrics

Details

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