(2019). Design characteristics, risk of bias, and reporting of randomised controlled trials supporting European Medicines Agency approvals of cancer drugs, 2014-2016: Cross-sectional analysis. BMJ , 366

OBJECTIVE To examine the design characteristics, risk of bias, and reporting adequacy of pivotal randomised controlled trials of cancer drugs approved by the European Medicines Agency (EMA). DESIGN Cross sectional analysis. supplementary appendices. Pivotal randomised controlled the Study design characteristics (randomisation, comparators, and endpoints); risk of bias using the revised Cochrane tool (bias arising from the randomisation process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result); and reporting adequacy (completeness and consistency of information in trial protocols, publications, supplementary appendices, clinical trial registry records, and regulatory documents).

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