Critical appraisal:Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, et al 2015 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?

Adequately concealed (e.g. central randomisation, numbered or coded bottles, drugs prepared by pharmacy).

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

Low risk of bias

Additional comments: Please replace this text and include any additional comments in regards to your risk of bias rating

This appraisal has been completed.

Article

Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, et al. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet 2015 Aug 1;386(9992):444-51 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26037941.

Assigned to

User:Meghna.kakani

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

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