Conclusions
active cancer
In this cross-sectional study, we detected a high rate of PEP changes among active cancer RCTs that occurred after trial initiation. Collectively, these PEP discrepancies were independently associated with trial positivity and were markedly underreported in published articles. The findings suggest that revision of journal policies to require trialists to publish and report PEP changes within the article and to provide protocols with multiple versions for reference is needed. The implications of PEP changes on trial outcomes and patient care need to be further elucidated.