Public comment period · §3
Draft monograph: KPV — 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-KPV-MONOGRAP/001 | Dr Nikolai Yeovil-Bakare | The pharmacokinetic section does not connect half-life to the dosing schedule | Accepted |
| DRAFT-KPV-MONOGRAP/002 | Dr Evander Whitmarsh-Obi | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-KPV-MONOGRAP/003 | Dr Jozef Brandvold-Achterberg | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-KPV-MONOGRAP/009 | Dr Wojciech Kaltenbach-Mensah | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-KPV-MONOGRAP/011 | Dr Rosalind Grünbaum-Sowande | Regulatory status is stated without naming the jurisdiction | Accepted |
| DRAFT-KPV-MONOGRAP/004 | Kolawole Oppenheimer-Ade | What happens when the compound is stopped is not addressed | Accepted |
| DRAFT-KPV-MONOGRAP/012 | Ignatius Erlingsson | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-KPV-MONOGRAP/010 | Dr Wolfram Tollemache | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-KPV-MONOGRAP/008 | Dr Jerome Lavrentiev | The recorded evidence gaps omit outcomes a reader would consider material | Accepted in part |
| DRAFT-KPV-MONOGRAP/007 | Professor Chukwuemeka Rasmussen-Adeyemi | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-KPV-MONOGRAP/015 | Xenia Nyquist-Obiora | Adverse event frequencies are given without the denominator or the exposure period | Accepted |
| DRAFT-KPV-MONOGRAP/014 | Dr Rurik Haverkamp-Diallo | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-KPV-MONOGRAP/005 | Dr Delphine Ravensworth industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-KPV-MONOGRAP/006 | Dr Frideswide Grünbaum-Sowande | The population to which the headline estimate applies is not stated with the estimate | Accepted |
| DRAFT-KPV-MONOGRAP/013 | Dr Oisín Marchetti-Bassey | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| 15 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 8 | 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 | 2 | 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
- The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-KPV-MONOGRAP/001. The pharmacokinetic section now states approximate time to steady state alongside the half-life and dosing interval, with the assumption of first-order elimination stated, and records where the assumption is not supported for this compound.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-KPV-MONOGRAP/002. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-KPV-MONOGRAP/003. The analytical section is reduced to compound-specific content and cross-references the relevant standards for the general procedure, which shortens it substantially without removing what is not available elsewhere.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-KPV-MONOGRAP/009. Mechanistic claims not traceable to a primary source are removed, and those retained carry their source and a statement of whether the underlying work was conducted in vitro, in animals or in humans.
- Regulatory status is stated without naming the jurisdiction — arising from DRAFT-KPV-MONOGRAP/011. Every regulatory status statement now names the authority, states the date on which the status was verified, and is recorded per jurisdiction rather than as a single global assertion.
- What happens when the compound is stopped is not addressed — arising from DRAFT-KPV-MONOGRAP/004. Discontinuation trajectory is now an assessed outcome in every monograph where a contributing trial measured it, and a recorded evidence gap in every monograph where none did, so that its absence is visible rather than silent.
- Trials are described as terminated where they completed as planned — arising from DRAFT-KPV-MONOGRAP/012. 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 recorded evidence gaps omit outcomes a reader would consider material — arising from DRAFT-KPV-MONOGRAP/008. The evidence-gap section is now derived from the anchor and decision-relevant outcomes for the indication, and any such outcome measured by no contributing trial is recorded as not measured rather than omitted.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-KPV-MONOGRAP/007. The trial list now includes every registered trial the Institute identified, with its reporting status stated, and the monograph reports the proportion of registered trials for which no result has been posted or published.
- Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-KPV-MONOGRAP/015. Every reported frequency now carries the number of participants, the number of events and the exposure period, and comparator-arm figures are reported alongside rather than in a separate table.
- References should carry a persistent identifier for every cited source — arising from DRAFT-KPV-MONOGRAP/014. 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.
- The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-KPV-MONOGRAP/006. Every headline estimate now carries a one-line statement of the population in which it was observed, and the full eligibility criteria are reported in the included-studies table rather than only in the source.
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-059/3 · https://compoundevidence.com/comment-periods/draft-kpv-monograph/disposition/ · retrieved 30 July 2026