Bmc medical research the case against censoring of progression-free survival in cancer clinical trials – a pandemic shutdown as an illustration

HIGHLIGHTS

SUMMARY

In the context of PFS, possible intercurrent events include the typical situation of discontinuation from study treatment (e_g, due to toxicity) and/or initiation of another treatment prior to observing an event of progression or death. At least three approaches can be considered in such cases: consider progression events when they occur, regardless of protocol treatment discontinuation and/or initiation of subsequent treatment; consider such treatment change as an event; or censor patients when they stop treatment and/or initiate subsequent treatment. In fact, these analyses address different questions, respectively: (1 - treatment policy) "Does . . .

 



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