Public comment period · §3
Draft synthesis: Tirzepatide compared with semaglutide in… — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-TIRZEPATIDE-/001 | Dr Evander Ashworth-Danquah | The same concept is given three different names in one document | Accepted |
| DRAFT-TIRZEPATIDE-/002 | Dr Oisín Rautavaara | A continuity correction has been applied to zero-event arms without being reported | Accepted |
| DRAFT-TIRZEPATIDE-/003 | Dr Ndidi Ravensworth-Ilunga | The conclusion is stated more strongly than the certainty rating supports | Accepted |
| DRAFT-TIRZEPATIDE-/004 | Bertrand Ollerenshaw industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-TIRZEPATIDE-/005 | Dr Yaa Kettlewell | Baseline imbalance in a small contributing trial is not remarked on | Noted, no amendment |
| DRAFT-TIRZEPATIDE-/006 | Dr Odalys Thorsby-Nakamura | Two included studies do not meet the registered eligibility criteria | Accepted in part |
| DRAFT-TIRZEPATIDE-/007 | Dr Kolawole Isaksen-Balogun | Subgroup findings are reported that were not registered in the protocol | Accepted in part |
| 7 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 4 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 2 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 1 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 0 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- The same concept is given three different names in one document — arising from DRAFT-TIRZEPATIDE-/001. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
- A continuity correction has been applied to zero-event arms without being reported — arising from DRAFT-TIRZEPATIDE-/002. The correction is now named in the methods of every review in which one was applied, and rare-event outcomes carry a second estimate obtained by a method that does not require one.
- The conclusion is stated more strongly than the certainty rating supports — arising from DRAFT-TIRZEPATIDE-/003. Conclusion wording is now drawn from a fixed set of formulations tied to the certainty rating, so that a low certainty rating produces a statement that the evidence may suggest an effect and that the estimate is likely to change with further research.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-TIRZEPATIDE-/004. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
- Two included studies do not meet the registered eligibility criteria — arising from DRAFT-TIRZEPATIDE-/006. One study has been removed from the included set and the estimate recomputed, the exclusion reason for the third study has been corrected in the excluded-studies table, and the screening decisions are now recorded against the protocol version in force at the…
- Subgroup findings are reported that were not registered in the protocol — arising from DRAFT-TIRZEPATIDE-/007. Every subgroup analysis is now labelled as pre-specified or post hoc against the registered protocol, post hoc analyses are reported in a separate subsection without a certainty rating, and the protocol version against which the labelling was made is stated.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-CP-118/3 · https://compoundevidence.com/comment-periods/draft-tirzepatide-vs-semaglutide-t2d-synthesis/disposition/ · retrieved 30 July 2026