Synthetic composite, illustrative only. Not a real trial and contains no real data.
A sample Rigor Record · ADC-CT-DEMO-001
Phase III efficacy readout for a fictional therapy (synthetic composite)
Executive summary
Across the manuscript, protocol, registry entry, and statistical-analysis plan, Adcurare surfaced five candidate findings. Two are material: an intention-to-treat denominator that is inconsistent across documents, and a reported primary-endpoint P value that does not reconstruct from the stated test statistic. The remaining three concern a changed endpoint window, a secondary-endpoint claim that does not survive the prespecified multiplicity adjustment, and a missing prespecified subgroup. None of these findings is an accusation; each is a candidate that warrants author or sponsor response.
What the report claims.
- 01The therapy met its primary endpoint at the prespecified analysis timepoint.
- 02A key secondary endpoint showed a statistically significant benefit.
- 03The safety profile was consistent with the class and no new signals emerged.
Evaluated as one system.
- Primary publication (manuscript PDF)Publication
- Supplementary appendixSupplement
- Registry recordRegistryProspective registration
- Statistical analysis plan (SAP)Protocol/SAP
- CONSORT flow diagramFigure
Organized by materiality.
Each finding separates detection confidence from scientific materiality, links to its source passage and reconstructed calculation, and ends with a recommended follow-up.
Intention-to-treat denominator is inconsistent across documents
Source claim
The intention-to-treat population comprised 812 randomized participants.
“…the intention-to-treat population comprised 812 randomized participants (406 per arm)…”
Results, paragraph 1; Abstract
Detected inconsistency
The abstract and Results state 812 (406 per arm), but the CONSORT diagram sums to 806 (404 + 402) and Table 1 reports 806 at baseline. The 6-participant discrepancy is not reconciled anywhere in the manuscript or appendix.
Abstract/Results: 406 + 406 = 812 CONSORT: 404 + 402 = 806 Table 1 baseline total: 806 Δ = 6 participants (unreconciled)
Recommended follow-up
Which count is correct for the ITT population, and where are the 6 participants accounted for?
Reported primary-endpoint P value does not reconstruct from the stated statistic
Source claim
The primary endpoint was met (P = 0.048).
“…a statistically significant difference was observed for the primary endpoint (χ²(1) = 3.29, P = 0.048).”
Results, Table 2
Detected inconsistency
Recomputing a two-sided P value from χ²(1) = 3.29 yields P ≈ 0.070, not 0.048. Either the test statistic or the reported P value is misstated; as written, the primary endpoint would not cross the conventional 0.05 threshold.
P(χ²(1) > 3.29) = 0.0697 (two-sided) Reported: P = 0.048 To obtain P = 0.048, χ²(1) ≈ 3.91 would be required.
Recommended follow-up
Provide the exact 2×2 table and test used for the primary endpoint.
Primary-endpoint assessment window differs from the registry
Source claim
The primary endpoint was assessed at week 26.
“…the primary endpoint was assessed at week 26…”
Methods, Endpoints
Detected inconsistency
The prospective registry record and the SAP both specify a week-24 primary-endpoint window. The manuscript reports week 26. No amendment rationale is cited.
Recommended follow-up
Was the endpoint window amended, and if so, when relative to unblinding?
Secondary-endpoint significance does not survive the prespecified multiplicity adjustment
Source claim
A key secondary endpoint showed a statistically significant benefit.
“…a significant improvement was also observed in the key secondary endpoint (P = 0.041).”
Results, paragraph 3
Detected inconsistency
The SAP prespecifies a hierarchical testing procedure with an adjusted threshold of 0.025 for the key secondary endpoint. At P = 0.041 the endpoint does not meet the prespecified bar, so “significant” is not supported as stated.
Recommended follow-up
Report the secondary endpoint against its prespecified adjusted threshold.
A prespecified subgroup analysis is not reported
Source claim
Prespecified subgroup analyses were conducted.
“…prespecified subgroup analyses were conducted for the primary endpoint…”
Methods, Statistical analysis
Detected inconsistency
The SAP prespecifies subgroups by age, sex, and baseline severity. The manuscript and appendix report age and sex but omit the baseline-severity subgroup without explanation.
Recommended follow-up
Provide the prespecified baseline-severity subgroup result.
Potential decision impact · F1
A shifting denominator changes every per-protocol rate and can move the primary effect estimate. For diligence, it is a gating question before relying on the headline result.
Potential decision impact · F2
The primary-endpoint claim is the pivot of the readout. If the statistic is correct, statistical significance is not established as reported.
How this report was produced.
Adcurare assembled the publication, supplement, registry record, SAP, and CONSORT figure as one evidence system, extracted the consequential claims, cross-checked documents, and recomputed reported statistics. Candidate findings are separated by scientific materiality and reported with a detection confidence. On a real report, each material finding is routed to independent human review and the author or responsible party is offered an opportunity to respond before publication.
- This is a synthetic composite for illustration; it is not a real trial and contains no real data.
- Detection confidence reflects the strength of the internal evidence, not a probability of misconduct.
- Candidate findings are not conclusions; consequential findings require independent human review.
- Absence of a finding is not certification that a document is free of issues.
Every version, retained.
On published reports, every version is retained with its underlying evidence trail so findings can be corrected, updated, or withdrawn as new evidence emerges.
See this on your own evidence.
A pilot runs Adcurare on a real problem you choose, with scope and success metrics agreed in advance.