What's Happening?
A review of oncology submissions from 2021 to 2023 reveals that Health Technology Assessment (HTA) agencies in France, England, Germany, and Norway have shown limited acceptance of external control arms (ECAs) in clinical trials. ECAs are used as alternatives to phase III trials, allowing for comparisons without direct head-to-head trials. The review analyzed 175 ECAs from 123 HTA evaluation reports, finding that none were accepted without restrictions, and only 17% were not rejected. England had the highest rate of acceptance with restrictions at 41%, while Germany and Norway rejected all ECAs. The main issues identified were data quality, study design concerns, and statistical methodology limitations.
Why It's Important?
The limited acceptance of ECAs by HTA agencies highlights significant challenges in the regulatory landscape for oncology trials. ECAs offer a potential solution for conducting trials when traditional methods are not feasible, but their acceptance is hindered by methodological concerns and data quality issues. This situation affects pharmaceutical companies and researchers who rely on ECAs to expedite drug development and approval processes. The findings underscore the need for improved transparency and methodological consistency in ECA use, which could enhance their credibility and acceptance, ultimately impacting the speed and efficiency of bringing new cancer treatments to market.
