The answer is “yes”, but the question is in what way? an article from Che et al. (2024) examines the use of real-world data (RWD) in ETS evaluations from 2016-2023. During this period, 11% of STD presentations included real-world data. Furthermore, they find that:
The main sources of RWD considered in the presentations were disease registries and electronic medical records. RWDs were primarily used to provide an external control arm to allow comparisons within single-arm trials and to report long-term treatment effects by extrapolating survival data beyond trial follow-up. Adjustments for possible systematic differences between treatment groups have improved over time; however, approximately one-third of the submissions were still based on unadjusted treatment comparisons… More than one-third of the submissions were based on naïve and/or unadjusted treatment comparisons…
We see a trend towards greater use of RWD as part of the NICE HTA presentation.
Of the 64 STD presentations with RWD, two-thirds (n = 44) considered RWD for RCT analysis in the base case only, 9 were considered in both the base case and sensitivity analysis, and 11 considered RWD only in sensitivity/scenario analysis.
Confounding adjustments were made in the majority of cases (30 of 44), with the approaches used being weighting (n=20), matching (n=7), regression (n=4), and simulated treatment comparison (n=2 ).
Why wasn’t RWD used? For extrapolation of survival, several rationales were provided:
In 20 presentations, real-world RCT [external control arm] was considered inappropriate for extrapolation for several reasons, such as (1) short follow-up, (2) inclusion of treatments not observed in UK clinical practice, and (3) key endpoints (e.g., disease-free survival). progression) not collected.
You can read the full article. here.
