Jim Carroll

Vice President, Real World Evidence, Commercialisation and Outcomes

Real world evidence (RWE) is expected to have a significant impact on how healthcare technologies and biopharmaceuticals will be developed and consumed.

Real world data (RWD), the underlying data supporting the generation of RWE, encompasses all information generated in routine medical practice such as electronic health records (EHR), claims data, pharmacy data, and clinical outcomes assessments. It also includes epidemiological data, registry data, health survey data, plus a host of new forms of information such as social media data, wearables-derived data, sensor and behavioural data.

Large scale computational power to apply against RWD is becoming increasingly affordable and accessible to all stakeholders. As such, this creates greater opportunities for real world insights into patient behaviours, treatment costs and drug performance.

While there is an expectation that all pharma companies will need to have RWE strategies in place, one of the biggest roadblocks in using RWE is the inadequate data in electronic healthcare records (EHR). This is because the traditional outcome measures that are used in conventional drug development are not generally found in EHRs. The challenge is that much of the needed clinical information is contained in doctor’s notes as unstructured data. Advances in machine learning and natural language processing are expected to provide some resolution to this challenge and will enable practitioners to mine the valuable data within unstructured clinical notes within EHR.

Moreover, as most sources of RWD are not actually collected for research purposes, data quality is an issue. EHRs, for example, are primarily intended for patient management, rather than for research, and there is a need for more alignment across all stakeholders to develop consistent data structure and gathering methods. 

RWE clearly has huge potential to inform healthcare stakeholders. While there are still multiple challenges with RWE becoming a consistent mainstay of the healthcare regulatory oversight and commercial performance insight, it is clear that there is an appetite among all stakeholders to resolve them. 

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This blog is an edited version of “Tackling RWE Challenges to Demonstrate Healthcare Value” which appeared in Scrip Informa Pharma Intelligence on 2nd January 2018. To view the full article, please visit https://scrip.pharmaintelligence.informa.com/