We summarise a recent article, published in JAMIA, that reviewed the scope of database-specific RWD applications within clinical trial contexts.
Clinical trials are important for developing medical evidence. While they have their strengths, such as incorporation of randomisation to minimise confounding, they still face various challenge. A common challenge is patient recruitment and retention. High operational costs can also make clinical trials difficult to conduct. Even if the trial is completed, the findings may have limited generalisability due to strict eligibility criteria, different settings and unrepresentative participants.
One potential solution is the use of real-world data (RWD). RWD can be advantageous, as these sources often contain a large representative population with rich healthcare data collected longitudinally. Database-specific RWD, including electronic health records (EHRs), are of particular interest and have been leveraged for clinical trial conduct. The most common instance is for pragmatic trials, which tend to focus on questions related to decision-making.
In this study, researchers aimed to systematically scope how database-specific RWD, particularly in the US, is used in clinical trial conduct. Their objectives were to (1) assess available literature on database-specific RWD as it relates to clinical trial conduct, (2) synthesise prominent themes for how RWD has been used and (3) examine potential opportunities for leveraging RWD within clinical trials. Specifically, they queried three biomedical literature databases, research articles using electronic health records, administrative claims databases and clinical registries.
Of the 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims and 26 used registries. They found that despite a diverse set of diseases explored, <10% of trials using RWD for trial process tasks evaluated medications or procedures. In other words, there was an apparent underuse of RWD within medication or procedure trials. Additionally, all articles described data-related challenges, such as missing values.
It is important to further explore the appropriate uses of RWD to optimise use of RWD across all source types. While it is clear that RWD has promise for clinical trials, it still requires continued evaluation in order to uncover the best methods to maximise its full potential.
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