Public comment period · §3
Draft monograph: GHRP-2 — 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-GHRP-2-MONOG/001 | Dr Piotr Hollingworth | A rise in insulin-like growth factor 1 is reported in the position of a clinical outcome | Accepted |
| DRAFT-GHRP-2-MONOG/002 | Dr Ilona Mbatha-Fredriksen | The absence of paediatric evidence is not stated where a reader would look for it | Accepted |
| DRAFT-GHRP-2-MONOG/003 | Dr Vittoria Quintanilha | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-GHRP-2-MONOG/004 | Dr Matthias Wintringham industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-GHRP-2-MONOG/005 | Anselm Mountstephen | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-GHRP-2-MONOG/006 | Eamon Sandringham-Adu | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-GHRP-2-MONOG/007 | Dr Ivo Quintanilha | Open-label extension data are presented alongside randomised data without distinction | Accepted |
| 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 | 0 | 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
- A rise in insulin-like growth factor 1 is reported in the position of a clinical outcome — arising from DRAFT-GHRP-2-MONOG/001. Biomarker responses now appear in §2 and are excluded from the assessed-outcome table unless the surrogate relationship has been validated, in which case the validation evidence is cited beside it.
- The absence of paediatric evidence is not stated where a reader would look for it — arising from DRAFT-GHRP-2-MONOG/002. The population table now carries a paediatric row in every monograph, and where evidence exists the trials are named.
- Trials are described as terminated where they completed as planned — arising from DRAFT-GHRP-2-MONOG/003. Trial status now uses a fixed vocabulary defined in the glossary, and where the reason for stopping is not evidenced by a document the Institute holds, the status is recorded as stopped with the reason not established rather than assigned.
- The compound is supplied under names the monograph does not list — arising from DRAFT-GHRP-2-MONOG/005. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
- References should carry a persistent identifier for every cited source — arising from DRAFT-GHRP-2-MONOG/006. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
- Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-GHRP-2-MONOG/007. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
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-051/3 · https://compoundevidence.com/comment-periods/draft-ghrp-2-monograph/disposition/ · retrieved 30 July 2026