2011
DOI: 10.1001/jama.2011.1476
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Defining Variations in Survival of BRCA1 and BRCA2 Mutation Carriers

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“…These phenotypic characteristics have important implications for clinical trial design in EOC. If BRCA-status is not incorporated in clinical trials as a stratification factor or is not accounted for by preplanned statistical analysis then there is a significant risk for bias that may be introduced by unequal numbers of BRCA1/2-associated patients included in different study cohorts [38,101]. BRCA-status should be considered not only for clinical trials of PARPi or other drugs, but also in any clinical trial with a survival (PFS or overall survival) or chemosensitivity end point.…”
Section: Implications Of Brca-status For Clinical Trial Designmentioning
confidence: 99%
“…These phenotypic characteristics have important implications for clinical trial design in EOC. If BRCA-status is not incorporated in clinical trials as a stratification factor or is not accounted for by preplanned statistical analysis then there is a significant risk for bias that may be introduced by unequal numbers of BRCA1/2-associated patients included in different study cohorts [38,101]. BRCA-status should be considered not only for clinical trials of PARPi or other drugs, but also in any clinical trial with a survival (PFS or overall survival) or chemosensitivity end point.…”
Section: Implications Of Brca-status For Clinical Trial Designmentioning
confidence: 99%