Public comment period · §3
Draft synthesis: Amylin analogues as monotherapy and 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-AMYLIN-ANALO/001 | Dr Theodora Ingelbrecht | Doses differing several-fold are pooled without examining dose-response | Accepted |
| DRAFT-AMYLIN-ANALO/002 | Dr Melisande Thorsby-Nakamura | Analytical surveys are treated as evidence about suppliers when they establish only what was in a sample | Accepted |
| DRAFT-AMYLIN-ANALO/003 | Dr Wolfram Quintanilha industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-AMYLIN-ANALO/004 | Dr Evander Ashworth-Danquah | An indirect comparison is presented without an assessment of transitivity | Accepted |
| DRAFT-AMYLIN-ANALO/005 | Dr Matthias Wintringham industry | A sponsor trial meeting the eligibility criteria was excluded | Accepted in part |
| DRAFT-AMYLIN-ANALO/006 | Professor Bartolomeu Nkosi-Lindegaard | Regulatory assessment documents were not searched | Accepted in part |
| DRAFT-AMYLIN-ANALO/007 | Anselm Mountstephen | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-AMYLIN-ANALO/008 | Dr Adaeze Underhill-Okafor | The review question is drawn too broadly to be answerable | Not accepted |
| DRAFT-AMYLIN-ANALO/009 | Quentin Whitmarsh-Obi | The review does not say when it will be updated or what would trigger an update | Accepted |
| 9 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 | 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
- Doses differing several-fold are pooled without examining dose-response — arising from DRAFT-AMYLIN-ANALO/001. Estimates are now reported by dose group, a dose-response examination is reported where three or more dose levels contribute, and the pooled across-dose estimate is removed rather than retained alongside.
- Analytical surveys are treated as evidence about suppliers when they establish only what was in a… — arising from DRAFT-AMYLIN-ANALO/002. Provenance is now assessed for every included survey and reported as a study characteristic, surveys without establishable provenance are reported separately rather than pooled with those that have it, and no supplier-level inference is drawn from a…
- An indirect comparison is presented without an assessment of transitivity — arising from DRAFT-AMYLIN-ANALO/004. Transitivity is now assessed against a stated list of effect modifiers and reported before any indirect estimate, and where the assessment fails the contrast is reported as unestimable with the reason rather than estimated with a caveat.
- A sponsor trial meeting the eligibility criteria was excluded — arising from DRAFT-AMYLIN-ANALO/005. The trial is added to the included set, the estimate and the certainty rating have been recomputed, and the screening record now states why the trial was missed, which was a database indexing gap rather than a screening judgement. The submission is identified…
- Regulatory assessment documents were not searched — arising from DRAFT-AMYLIN-ANALO/006. Published regulatory assessment documents are now searched as a named source, are reported as a distinct evidence class in the included-studies table, and contribute to the assessment while being excluded from pooled estimates where risk of bias could not be…
- The review does not say when it will be updated or what would trigger an update — arising from DRAFT-AMYLIN-ANALO/009. Every synthesis now records a scheduled review date and a stated update trigger, being the reporting of a trial that would materially change the contributing evidence, and the registered trials capable of triggering an update are listed by name.
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-112/3 · https://compoundevidence.com/comment-periods/draft-amylin-analogue-evidence-synthesis/disposition/ · retrieved 30 July 2026