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.
Trials are described as terminated where they completed as planned
The respondent states that the draft uses the word terminated for trials stopped at pre-specified interim analyses, for trials stopped for futility and for trials closed for commercial reasons, and that these are three different facts.
The respondent proposes that the status vocabulary be fixed and defined in the glossary.
The secretariat accepts this submission in part. The vocabulary is fixed and defined. The proposal to distinguish commercial closure from futility in every case is accepted only where the Institute holds a document stating the reason.
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 certainty rating for the principal assessed outcome cannot be traced to the contributing trials
The draft states a certainty rating for the principal assessed outcome and lists the contributing trials, but does not state which domain drove the downgrade. A reader who disagrees with the rating cannot tell whether the disagreement concerns risk of bias, imprecision, indirectness or inconsistency.
The respondent proposes that each rating carry its downgrade reasons explicitly, in the same row as the rating, so that a reader can accept the evidence assessment while disputing a single domain judgement.
The secretariat accepts this submission. A rating without its reasoning is an assertion, and the draft asserted rather than showed.
Each assessed outcome now carries its downgrade domains in the summary-of-findings row, with a short statement of the judgement made in each, so that the rating can be checked domain by domain against the contributing trials.
The indication table mixes approved indications with uses for which the compound is merely supplied
The indication table lists indications in a single sequence. Some are approved by a competent authority, some are the subject of trials that have not reported, and some are uses observed in supply with no trial evidence at all.
The respondent, employed by a national competent authority and writing in a personal capacity, states that the three categories should not share a table without being distinguished in it.
The secretariat accepts this submission. A shared table is an implicit claim of comparable standing.
The indication table now carries a status column with three values, approved, under investigation and supplied without trial evidence, and the value is stated for every row. Rows in the third category also state that no certainty rating is assigned because there is no evidence base to rate.
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.