A study published this week in JAMA Network Open finds that currently available real-world data (RWD) sources can only be used to feasibly replicate 15% of clinical trials.
The aim of the study was to determine whether RWD could be used to power observational studies that answer the same clinical questions as traditional clinical trials.
Randomized controlled trials (RCTs) are considered the gold standard for clinical evidence to support the safety and efficacy medical products due to high levels of internal consistency and reduced bias.
However, as the authors of the study write, “Compared with RCTs, RWE [real-world evidence] better reflects the actual clinical environments in which medical interventions are used, including patient demographics, comorbidities, adherence, and concurrent treatments,” noting that RCTs are costly and time intensive compared to observational studies.
To conduct the study, the authors reviewed 220 clinical trials conducted in the US that were published in the top seven medical journals in 2017 and determined whether RWD obtained from insurance claims and electronic health records (EHRs) contained the information necessary to replicate the studies…