Public comment period · §3
Draft monograph: Thymosin alpha-1 — 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-THYMOSIN-ALP/001 | Dr Ivo Quintanilha | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-THYMOSIN-ALP/002 | Dr Frideswide Hazelrigg | The absence of paediatric evidence is not stated where a reader would look for it | Accepted |
| DRAFT-THYMOSIN-ALP/003 | Dr Theodora Ingelbrecht | The document should state what a reader ought to do | Not accepted |
| DRAFT-THYMOSIN-ALP/004 | Dr Rurik Underhill-Okafor | Nothing is said about impaired renal or hepatic clearance | Accepted |
| DRAFT-THYMOSIN-ALP/005 | Dr Odalys Thorsby-Nakamura | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-THYMOSIN-ALP/006 | Anselm Mountstephen | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-THYMOSIN-ALP/007 | Bertrand Ollerenshaw industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-THYMOSIN-ALP/008 | Dr Zdenka Nyquist-Obiora | The preclinical section is extensive and the clinical section is not | Accepted in part |
| DRAFT-THYMOSIN-ALP/009 | Dr Hyacinth Drakeford-Amadi | The interaction section lists mechanisms rather than interactions | Accepted in part |
| DRAFT-THYMOSIN-ALP/010 | Dr Yehudit Yorkstone | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-THYMOSIN-ALP/011 | Dr Adaeze Underhill-Okafor | Effect estimates are given without naming the comparator | Accepted |
| DRAFT-THYMOSIN-ALP/012 | Dr Henrike Jastrzębska | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-THYMOSIN-ALP/013 | Dr Vittoria Quintanilha | Registered trials that never reported are absent from the monograph | Accepted |
| 13 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 6 | 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 | 5 | 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 | 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
- Trials are described as terminated where they completed as planned — arising from DRAFT-THYMOSIN-ALP/001. 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 absence of paediatric evidence is not stated where a reader would look for it — arising from DRAFT-THYMOSIN-ALP/002. The population table now carries a paediatric row in every monograph, and where evidence exists the trials are named.
- Nothing is said about impaired renal or hepatic clearance — arising from DRAFT-THYMOSIN-ALP/004. The pharmacokinetic table now carries renal and hepatic rows in every monograph, populated with the study where one exists and with an explicit statement of absence where none does.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-THYMOSIN-ALP/005. 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…
- References should carry a persistent identifier for every cited source — arising from DRAFT-THYMOSIN-ALP/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.
- The preclinical section is extensive and the clinical section is not — arising from DRAFT-THYMOSIN-ALP/008. The preclinical section is reduced in length, placed after the clinical assessment rather than before it, and opens with a standing statement that an effect observed in an animal model is not a clinical outcome and does not support a certainty rating.
- The interaction section lists mechanisms rather than interactions — arising from DRAFT-THYMOSIN-ALP/009. The interaction section is now divided into interactions reported in clinical use and interactions predicted from mechanism, with the second labelled as prediction. Where neither exists the section says so in one line rather than being padded.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-THYMOSIN-ALP/010. 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.
- Effect estimates are given without naming the comparator — arising from DRAFT-THYMOSIN-ALP/011. The comparator is now stated in every outcome row, and estimates against different comparators are reported in separate tables with the comparator named in the table caption.
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-THYMOSIN-ALP/012. 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.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-THYMOSIN-ALP/013. 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.
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-082/3 · https://compoundevidence.com/comment-periods/draft-thymosin-alpha-1-monograph/disposition/ · retrieved 30 July 2026