STAT+: 1 in 5 primary endpoints changed in late-stage trials of cancer drugs already underway, study finds
The findings raised questions about the quality of the clinical trials, as well as a risk that the results reflected bias toward selecting a particular outcome.
Amid increased concerns over a lack of transparency in clinical trials, a new study found that one in five primary endpoints were changed after a late-stage study had begun, and 70% of the trials examined did not include information about primary endpoint changes in articles published in medical journals.
Specifically, 145 of 755 randomized controlled trials for cancer medications — or 19% — had changes to the primary endpoints when using at least one of three different methods to detect any differences. Of the 145 trials with changes, 102 — or 70% — did not disclose them in published manuscripts.
As a result, the findings raised questions about the quality of the clinical trials, as well as a risk that the results reflected bias toward selecting a particular outcome, according to the authors of the study, which was published in JAMA Network Open.
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