Many Pivotal Cancer Trials Change Endpoints Mid-Study, But Few Report It, Study Says
One in five active phase 3 cancer trials changes its primary endpoints during the study but fewer than one-third of them report the modifications in publications, a new study published in JAMA Network Open found, adding another facet to industry concerns about trial transparency.
Researchers from the University of Texas MD Anderson Cancer Center, Baylor College of Medicine, Johns Hopkins University School of Medicine and other institutions looked at 755 completed phase 3 oncology trials from inception through February 2020, combing ClinicalTrials.gov for evidence of altered endpoints using three avenues: history of tracked changes in the database itself, self-reported changes in publications and changes reported in the protocol, including all available protocol documents.
Of the 755 trials assessed, 145 (19.2 percent) showed primary endpoint changes detected by at least one of these methods. Of these 145 trials, 102 (70.3 percent) did not disclose their endpoint changes.
Read the study here: https://bit.ly/45AEXKC.