Beoordeling antikankermiddelen verloopt zorgvuldig

Commentaar
14-05-2018
Frans L. Opdam

Nieuwe antikankermiddelen worden in Europa centraal beoordeeld op kwaliteit, effectiviteit en veiligheid, waarbij de European Medicines Agency (EMA) een organiserende rol heeft.1 Het uitgangspunt van zo’n beoordeling is het opstellen van een zogenaamde baten-risicoanalyse. Wanneer de farmaceutische kwaliteit van het geneesmiddel voldoende is en de effectiviteit opweegt tegen de bijwerkingen, kan dit uiteindelijk leiden tot registratie.

Evaluation of anticancer drugs is a careful process

The conclusion of Davis et al. that most anticancer drugs have been approved without any proof of survival or quality of life benefit (BMJ. 2017;359:j4530) should be more nuanced. It is not always necessary to choose a gain in survival as the primary outcome measure, indeed in some situations a different outcome measure may be more relevant. It is important that the study on the basis of which an anticancer drug will be registered, is correct regarding design and endpoints. Uncontrolled studies with surrogate endpoints should be an exception rather than becoming the standard design. The studied population must also be representative of patients in daily practice. The Dutch Medicines Evaluation Board is aware of, and welcomes, the fact that there are discussions within the European Medicines Agency that involve the relevance of clinical outcome measures and the validation of quality of life questionnaires.

Conflict of interest and financial support: none declared.