Drugs

Drug Companies’ Greater Use of Real-World Evidence: Report

The use of real-world evidence (RWE) and data is growing and assuming great importance for drug companies in drug development, patient safety, and commercialization. That’s a key takeaway from a Tufts Center for the Study of Drug Development survey of 30 drug companies to assess current and planned use of real-world evidence and real-world data (RWD) in drug development and post-marketing safety efforts.

The center’s November/December Impact Report (subscription or purchase required) says that RWE poses a number of challenges associated with data availability and reliability, data source quality, the cost and effort of data integration, and acceptance by key stakeholders. It says that new technology solutions that integrate disparate data sources, including RWE, are expected to play an important role in addressing availability and cost issues.

Some 64% of the surveyed companies said their RWE function is centralized and globally supporting other functions across the organization. Organizations said they use a variety of data elements to support an NDA, including claims data (used by 95% of survey respondents), electronic health record clinical data (71%), prescription data (67%), patient-reported outcomes or survey data (48%), and demographic data (48%). Also used were biomarker and genomics data (38%) and protocol feasibility data (29%).

Many companies expect to make greater use of social media in the future, while reducing use of claims and prescription data.

Survey respondents said the foremost use of RWE is to evaluate and improve the economic value of products (75%) and to strengthen their market position (75%). Use of RWE also focuses on more effective use of data for decision-making (63%), more efficient patient recruitment (50%), and improved completion of post-marketing requirements (46%).

Some 60% of respondents said availability of data posed the greater challenge in using RWE, followed by lack of external stakeholder trust in RWE (35%), and the cost of acquiring data (25%).

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