Case Study B
Why late-stage timeline changes matter
This case uses an in-corpus timeline record from NCT02942355. It shows how TrialDiff separates a factual registry movement from any claim about intent, quality, or wrongdoing.
Record
TrialDiff compares ClinicalTrials.gov versions 26 and 27 for NCT02942355, a Wake Forest University Health Sciences study titled "Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer."
Evidence Record: evt_NCT02942355_v26_v27_f30d5b213a35
Canonical JSON: /events/evt_NCT02942355_v26_v27_f30d5b213a35.json
What Changed
The patch replaced both the primary completion date and completion date with 2028-06-30. It also
updated status verification and last-update registry fields.
TrialDiff's value signal records a 731-day timeline movement. The changed paths are concentrated in the status module, which makes this record a cleaner teaching case than a large multi-module patch.
Why It Carried The Critical Triage Label
The timeline rule treated a movement greater than 365 days as a major slip, giving the event a high base triage severity.
The from-version timing context was late_recruitment, so the timing modifier escalated the final
triage severity to critical.
What This Supports
This record supports a narrow factual statement: between versions 26 and 27, trial timeline fields moved by 731 days, the movement occurred in a late-recruitment context, and TrialDiff assigned the amendment a deterministic timeline triage label.
What This Does Not Support
This case does not show misconduct, sponsor intent, scientific unjustifiability, manuscript non-disclosure, or regulatory non-compliance. It does not determine whether the amendment was a delay, a backfill, a correction, or an expected operational update.
The correct next question is the record's own review question: what explains the major timeline movement, and does the amendment represent a delay, a backfill, or a correction?