When and how can endpoints be changed after initiation of a randomized clinical trial?
2007
Changing Endpoints in Clinical Trials
publication
Author Information
Author(s): Scott Evans
Primary Institution: Harvard School of Public Health
Hypothesis
When and how can endpoints be changed after the initiation of a randomized clinical trial?
Conclusion
Revisions to endpoints should be uncommon, but important scientific knowledge gained after a trial begins may warrant careful evaluation for incorporation into the trial.
Supporting Evidence
- Many trials have changed their study endpoints after trial initiation.
- 62% of trials had at least one primary endpoint that had been changed, introduced, or omitted.
- Changes to endpoints are frequent and should be evaluated for appropriateness.
Takeaway
Sometimes, scientists need to change the goals of their studies while they are still happening to make sure they are asking the right questions.
Potential Biases
Changing endpoints can lead to 'cherry-picking' results that may inflate false positive rates.
Limitations
Revisions to endpoints can compromise the scientific integrity of a trial if not handled properly.
Digital Object Identifier (DOI)
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