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A novel framework to assess haematology and oncology registration trials: The THEOREMM project

Methodological limitations affect a significant number of oncology and haematology trials, raising concerns about the applicability of their results. For example, a suboptimal control arm or limited access to best… Click to show full abstract

Methodological limitations affect a significant number of oncology and haematology trials, raising concerns about the applicability of their results. For example, a suboptimal control arm or limited access to best care upon progression may skew the trial results toward a benefit in the experimental arm. Beyond the fact that such limitations do not prevent drugs reaching the market, other assessment tools, such as those developed by professional societies—ESMO‐MCBS and ASCO Value Framework—do not integrate these important shortcomings.

Keywords: oncology; novel framework; assess haematology; haematology; framework assess

Journal Title: European Journal of Clinical Investigation
Year Published: 2024

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