Primary Endpoint Changes Common in Cancer Trials

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Primary Endpoint Changes Common in Cancer Trials
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Changes to primary endpoints in phase 3 cancer trials occur frequently and are often undisclosed in study manuscripts, new research shows.

Lack of transparency in randomized controlled trials remains a"pressing concern," despite efforts to make protocols available and require clinical trial registration. And it's unclear how often clinical trials report changes in primary endpoints.

Overall, the team found that 19% of trials underwent primary endpoint changes during the trial, but the rates of primary endpoint changes detected using the three methods varied considerably. The highest rate of changes was detected in published protocols , followed by ClinicalTrials.gov , and self-reported .

The most frequent primary endpoint changes involved reporting a primary endpoint as a secondary endpoint , making a change to the primary endpoint definition , and changing a secondary endpoint to a primary endpoint . Of 145 trials with primary endpoint changes, 61% were positive compared with only 51% without a primary endpoint change. In multivariable analysis, a primary endpoint change was independently associated with trial positivity .

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