Choice of control group in randomised trials of cancer medicine: are we testing trivialities?

The Lancet Oncology

31 August 2018 - Several trials in cancer medicine over the past 5 years share two common features: first, they were used—or were intended to be used—to seek marketing authorisation from the US FDA or the EMA, and second, they test an experimental group against a weak comparator that is infrequently used in practice. 

The choices of comparators in four trials—those of ibrutinib and rituximab versus rituximab in Waldenström's macroglobulinaemia,  ibrutinib versus chlorambucil in chronic lymphocytic leukaemia,  bortezomib (Velcade), melphalan, and prednisone with or without daratumumab for multiple myeloma,  and nivolumab versus dacarbazine in melanoma  —suggest that large randomised controlled trials are being done with the aim of gaining regulatory authorisation, while testing trivial clinical questions.

Read The Lancet Oncology article

Michael Wonder

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Michael Wonder