Key result
NASH clinical trials need standardized case definitions to address disease heterogeneity and improve study comparability.
Why the study?
There is a major unmet need to develop standardized case definitions for populations in NASH interventional trials to improve comparability and endpoint construction.
This paper provides multistakeholder recommendations for standardized case definitions to improve the design and comparability of clinical trials for nonalcoholic steatohepatitis.
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May support harmonized NASH trial design; leaves open whether definitions improve comparability until prospectively validated.
Siddiqui et al. (2017) conducted a review in Nonalcoholic steatohepatitis (NASH). Standardized case definitions was evaluated. Standardized case definitions for nonalcoholic steatohepatitis clinical trials are needed to address heterogeneous disease parameters and improve the comparability of interventional study results.
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