Critical appraisal:Ascierto PA, McArthur GA, Dréno B, Atkinson V, Liszkay G, Di Giacomo AM, et al 2016 2

Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?

I am reasonably certain that the trial was double-blinded (eg identical placebo, active placebo, double-dummy, no revealing side-effects).

Was the treatment allocation schedule concealed?

No concealment or unclear (e.g. no approach described, open randomisation lists, person doing recruitment tossing a coin).

Were all randomised participants included in the analysis?

No exclusions or survival analysis used with all subjects included (>95% follow-up for all groups).

The field below is not considered when calculating the risk of bias rating

How was the allocation schedule generated?

Adequate (e.g. random number table, computer random generator, coin tossing, card shuffling)

Overall risk of bias

High risk of bias

Additional comments: double blinded, treatment allocation described (stratified permuted block randomisation scheme via an interactive response system), intention to treat population

This appraisal has been completed.

Article

Ascierto PA, McArthur GA, Dréno B, Atkinson V, Liszkay G, Di Giacomo AM, et al. Cobimetinib combined with vemurafenib in advanced BRAF(V600)-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial. Lancet Oncol 2016 Sep;17(9):1248-60 Available from: http://www.ncbi.nlm.nih.gov/pubmed/27480103.

Assigned to

User:Cecilia.taing

Topic area

Guidelines:Melanoma

Clinical question

• Does systemic drug therapy improve progression-free, overall survival in unresectable stage III and stage IV melanoma?

Form

Form:Quality appraisal rct

Section below only relevant for Cancer Council Project Officer

Edit appraisal assignment