“Progression-free survival as an end-point in clinical trials of biotherapeutic agents”

Progression-free survival (PFS), the time from registration or randomisation of a patientuntil objective disease progression or death, can be considered as an outcome for clinicalresearch and also as a basis for regulatory approval. Current experience suggests thatgreater standardisation and consistency are needed for clinical trials utilising PFS endpoints.To this end, the Biotherapy Development Association (BDA) convened a breakoutsession on the topic of PFS during its Third Alpine Meeting held 14–16 March 2007. Representativesof the pharmaceutical industry, regulatory agencies, academia, and patientadvocacy groups identified challenges, developed recommendations, and worked to buildconsensus regarding the conduct of clinical trials utilising PFS as an end-point to helpspeed new targeted biologics to the patient bedside.