Public comment period · §3
Draft synthesis: The consequences of a wholly… — 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-SPONSOR-COND/005 | Dr Odalys Thorsby-Nakamura | Results at materially different follow-up durations are pooled | Accepted |
| DRAFT-SPONSOR-COND/008 | Dr Ursina Ellsworth-Vance | The document should state what a reader ought to do | Not accepted |
| DRAFT-SPONSOR-COND/007 | Dr Piotr Hollingworth | The search strategy as published cannot be re-run | Accepted |
| DRAFT-SPONSOR-COND/002 | Dr Yehudit Quaresma | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-SPONSOR-COND/010 | Dr Oisín Rautavaara industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-SPONSOR-COND/004 | Dr Anselm Mountstephen | The same concern is used to downgrade in two domains | Accepted in part |
| DRAFT-SPONSOR-COND/009 | Dr Gaspard Wintringham industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-SPONSOR-COND/001 | Dr Yolanda Norrington-Bhatt | Patient-reported outcomes are collected by the trials and not reported by the review | Accepted in part |
| DRAFT-SPONSOR-COND/006 | Sigrún Vercingetorix | A surrogate outcome is used as the anchor without validation evidence | Accepted in part |
| DRAFT-SPONSOR-COND/003 | Dr Wilhelmina Oppenheimer-Ade | The document is unreadable without specialist training | Accepted in part |
| 10 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 3 | 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 | 4 | 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 | 2 | 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
- Results at materially different follow-up durations are pooled — arising from DRAFT-SPONSOR-COND/005. Estimates are now reported by duration band, with the number of contributing trials and participants in each band stated, and no estimate is pooled across bands.
- The search strategy as published cannot be re-run — arising from DRAFT-SPONSOR-COND/007. The full line-by-line strategy for each database is now published with the interface, the run date and the yield at each line, and the total retrieved is reconciled against the screening flow.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-SPONSOR-COND/010. 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…
- The same concern is used to downgrade in two domains — arising from DRAFT-SPONSOR-COND/004. The rating for the first outcome has been raised by one level and the domain reasoning restated, and the reasoning for the second has been rewritten to make clear that the two downgrades rest on different features of the evidence.
- Patient-reported outcomes are collected by the trials and not reported by the review — arising from DRAFT-SPONSOR-COND/001. Patient-reported outcomes measured by any contributing trial are now reported narratively by instrument, with the instrument named and its minimum important difference stated where one is published, and the absence of a pooled estimate explained.
- A surrogate outcome is used as the anchor without validation evidence — arising from DRAFT-SPONSOR-COND/006. Where the anchor is a surrogate, the synthesis now states the evidence for the surrogate relationship, rates it separately, and downgrades the anchor rating for indirectness accordingly rather than carrying the surrogate as though it were the outcome of…
- The document is unreadable without specialist training — arising from DRAFT-SPONSOR-COND/003. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
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-110/3 · https://compoundevidence.com/comment-periods/draft-sponsor-conducted-evidence-base-synthesis/disposition/ · retrieved 30 July 2026