Draft monograph: danuglipron — submissions
The 3 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
3 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.
Open-label extension data are presented alongside randomised data without distinction
The draft on Danuglipron was read in full. The respondent notes at the outset that this class has an unusually deep randomised evidence base, and that a monograph on it is fairly judged against a higher standard than one on a compound with none.
Long-term figures in the clinical section come from open-label extensions in which every participant received the active compound and those who did not tolerate it had already withdrawn. They are printed in the same table as randomised comparisons and in the same typeface.
The respondent proposes that extension data be presented in a separate table, or at minimum in a separately labelled block, and that the surviving-population problem be stated once where it arises.
The secretariat accepts this submission. An extension estimate answers a different question from a randomised one and should not be read as though it answered the same one.
Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
Doses are expressed in units that differ between sections
The draft on Danuglipron is a substantial document and the respondent has confined this submission to one matter.
The draft expresses dose in milligrams in one section and in micrograms per kilogram in another, drawn from different sources without conversion. The respondent states that this is the shape of error that reaches a patient.
The respondent proposes a single unit throughout, with the source unit retained in parentheses where a conversion was performed.
The secretariat accepts this submission. The inconsistency was inherited from the sources and should have been resolved in drafting.
A single dose unit is now used throughout each monograph, with the source unit retained in parentheses wherever a conversion was applied, and every conversion is stated rather than performed silently.
The monograph should not describe how the compound is supplied outside a regulated route
The respondent read the draft on Danuglipron alongside the approved labelling for the class, and submits on one matter arising.
The respondent states that describing presentations observed in unregulated supply risks being read as a guide to obtaining them, and asks that the material be removed.
The respondent accepts that the information is accurate and objects to its presence rather than to its content.
The secretariat notes this submission and records the concern as a real one that the draft had already considered.
No amendment arises. The monograph describes what is supplied and names no supplier, price or route of acquisition, and it carries the standing statement that the Institute assesses evidence and does not recommend use. Describing a presentation a reader may already hold is the condition of being useful to that reader.
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
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