Public comment period · §3
Draft indication set and anchor outcomes — 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-INDICATION-S/001 | Dr Oswin Yorkstone | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-INDICATION-S/010 | Dr Mordecai Glendinning-Uche | A fixed section structure will force empty sections | Accepted in part |
| DRAFT-INDICATION-S/014 | Dr Vittoria Ylönen | The default ordering of a comparison table carries an implication | Accepted |
| DRAFT-INDICATION-S/011 | Dr Katarzyna Oppenheimer-Ade | A printed copy loses the information that makes it checkable | Accepted |
| DRAFT-INDICATION-S/002 | Dr Kamila Ubertini industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-INDICATION-S/012 | Dr Ivo Quintanilha | A field the Institute could not verify should be shown rather than omitted | Accepted |
| DRAFT-INDICATION-S/009 | Dr Vittoria Ylönen industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-INDICATION-S/003 | Dr Ludmila Castellanos-Reid | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-INDICATION-S/015 | Dr Anselm Thorsby-Nakamura | The series scope is drawn widely enough to absorb documents that belong elsewhere | Accepted in part |
| DRAFT-INDICATION-S/004 | Dr Vasilisa Immelmann | Point estimates are given without an interval | Accepted in part |
| DRAFT-INDICATION-S/013 | Dr Mordecai Glendinning-Uche | A withdrawn document should not simply disappear | Accepted |
| DRAFT-INDICATION-S/006 | Dr Henrike Jastrzębska | The same concept is given three different names in one document | Accepted |
| DRAFT-INDICATION-S/005 | Dr Liesbeth Delacroix-Njoku | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-INDICATION-S/008 | Dr Quentin Whitmarsh-Obi | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-INDICATION-S/007 | Dr Eamon Immelmann | The document is unreadable without specialist training | Accepted in part |
| 15 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 7 | 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 | 3 | 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 | 1 | 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
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-INDICATION-S/001. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
- A fixed section structure will force empty sections — arising from DRAFT-INDICATION-S/010. A section with nothing to report now states that fact and the reason in a fixed form, rather than being omitted or left blank, so that a reader can tell the difference between an absence of evidence and an absence of effort.
- The default ordering of a comparison table carries an implication — arising from DRAFT-INDICATION-S/014. The default ordering is now alphabetical, a standing statement above every comparison table records that the ordering is not a ranking, and the sort state is reset on reload so that a shared link does not carry an ordering the sender chose.
- A printed copy loses the information that makes it checkable — arising from DRAFT-INDICATION-S/011. The print stylesheet now carries the identifier, version, publication date and retrieval date on every page, expands link destinations into the text, and prints the full reference list rather than a link to it.
- A field the Institute could not verify should be shown rather than omitted — arising from DRAFT-INDICATION-S/012. Every field now carries one of four states, being verified, claimed and unverified, sought and not established, or not applicable, and the state is displayed rather than inferred from an empty cell.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-INDICATION-S/009. 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 series scope is drawn widely enough to absorb documents that belong elsewhere — arising from DRAFT-INDICATION-S/015. The series scope now carries an explicit exclusion list naming the document classes that do not belong to it and stating where each belongs instead, so that a placement decision is checkable rather than editorial.
- Point estimates are given without an interval — arising from DRAFT-INDICATION-S/004. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
- A withdrawn document should not simply disappear — arising from DRAFT-INDICATION-S/013. A withdrawn document is now replaced at its own address by a notice recording its identifier, its title, the date and ground of withdrawal, and a link to whatever supersedes it, and the withdrawal is recorded in the corrections log.
- The same concept is given three different names in one document — arising from DRAFT-INDICATION-S/006. 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.
- The document is unreadable without specialist training — arising from DRAFT-INDICATION-S/007. 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-024/3 · https://compoundevidence.com/comment-periods/draft-indication-set/disposition/ · retrieved 30 July 2026