Lessons Learned From Multi-regional Trials With Signals of Treatment Effect Heterogeneity.
Ther Innov Regul Sci
; 54(1): 21-31, 2020 01.
Article
em En
| MEDLINE
| ID: mdl-32008228
ABSTRACT
Inconsistent results across regions have been reported in a number of recent large trials. In this research, by reviewing results from studies that showed inconsistent treatment effects, and summarizing lessons learned, we provide some recommendations for minimizing the chance of inconsistency and allowing more accurate interpretation when such signs of heterogeneity arise, for example keep the number of regions for consistency evaluation at a minimum to avoid observing false inconsistency signals; proactively address in the protocol the differences in culture, medical practices, and other factors that are potentially different across regions; closely monitor the blinded data from early-enrolled patients to more effectively identify and address issues such as imbalance of baseline covariates or inconsistency of primary outcome rates across regions. For treatments of life-threatening conditions, the stakes for accurate interpretation of MRCT results are high; the criteria for decisions warrant careful consideration.
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MEDLINE
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Projetos de Pesquisa
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Ensaios Clínicos como Assunto
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Pesquisa Biomédica
Idioma:
En
Ano de publicação:
2020
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Article