Association of Industry and Academic Sponsorship With Negative Phase 3 Oncology Trials and Reported Outcomes on Participant Survival: A Pooled Analysis.

ABSTRACT:

Importance

Only 3.4% of cancer drugs evaluated in phase 1 trials are approved by the US Food and Drug Administration, with most failing in phase 3 trials.

Objective

To investigate whether an association exists between the sponsorship and conduct of a negative phase 3 randomized clinical trial (RCT) investigating a cancer drug that lacked supporting phase 2 trial evidence for that drug, and to evaluate the association with overall survival among patients randomized to the experimental arm of such phase 3 trials.

Data sources

Articles in the Lancet, Lancet Oncology, JAMA, JAMA Oncology, and Journal of Clinical Oncology published between January 2016 and June 2018 were searched.

Study selection

Phase 3 RCTs of cancer drugs that failed to improve the primary end po

SUBMITTER: Addeo A 

PROVIDER: S-EPMC6512293 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature