Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival

Abstract

Key Points Question Does an association exist between the sponsorship and conduct of phase 3 randomized clinical trials for cancer drugs despite negative or absent phase 2 trials for the drug, and does an association exist for overall patient survival and such phase 3 trials? Findings This analysis of 67 studies found that both industry and academia conducted negative phase 3 trials of cancer drugs. No association was found between trial sponsorship and lack of a positive phase 2 trial; there was no association with patient overall survival, although the survival hazard ratio was greater than 1 for 37% of such trials. Meaning Phase 3 trials conducted without supporting phase 2 trial evidence risks loss of resources owing to trial failure and may be associated with decreased patient survival.