Effect of cross-over in oncology clinical trials on evidence levels in early benefit assessment in Germany

Value in Health

13 June 2018 - In oncology clinical trials, cross-over is used frequently but may lead to uncertainties regarding treatment effects.

For oncology medicines with early benefit assessments before January 2015, presence of crossover, clinical data, EMA requests for additional data, and G-BA benefit ratings/evidence levels were analysed from manufacturers’ dossiers, G-BA appraisals, European Public Assessment Reports, and original publications.

Eleven of 21 benefit assessments included crossover trials. Significant inter-group differences (P < 0.05) in overall survival (OS) were noted in 7 of 11 trials with and 7 of 10 without cross-over.

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Michael Wonder

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Michael Wonder