Draft monograph: DSIP — submissions
The 4 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
4 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.
Storage and reconstitution guidance is given without stating what it rests on
The respondent submits on the draft monograph for DSIP. A neuroactive peptide raises a question the reader wants answered early, which is whether the compound reaches the compartment in which it is said to act.
The draft states storage conditions and a period of use after reconstitution. The respondent asks what evidence supports the period, and states that in the absence of a stability study on this presentation the figure is a convention rather than a finding.
The respondent proposes that any in-use period be accompanied by the stability evidence that produced it, or removed.
The secretariat accepts this submission in part. The period is retained where a stability study on a comparable presentation exists and is cited. Where no such study exists the figure is removed rather than annotated, because an annotated figure is still a figure a reader will use.
In-use periods now appear only where supported by a cited stability determination on a stated presentation, and elsewhere the monograph records that no in-use stability evidence was identified for this presentation.
The population to which the headline estimate applies is not stated with the estimate
The respondent notes that much of the source literature for DSIP is published in one national literature, and submits with that in view.
The draft carries a headline effect estimate in the abstract without the eligibility criteria of the trials that produced it. The respondent states that the estimate applies to a trial population with specific age, comorbidity and baseline criteria, and that a reader will apply it to whoever is in front of them.
The respondent proposes a one-line population statement adjacent to every headline estimate.
The secretariat accepts this submission. An estimate detached from its population is an estimate of nothing in particular.
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.
The interaction section lists mechanisms rather than interactions
The respondent has read the draft covering DSIP and makes one submission.
The section describes pathways by which an interaction could occur. It does not say which interactions have been observed, in what setting, or with what consequence. A reader dispensing alongside other therapy cannot act on a mechanism.
The respondent proposes that observed interactions be separated from theoretical ones, and that the theoretical ones be labelled as such.
The secretariat accepts the separation and declines to expand the section beyond the evidence.
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.
Regulatory status is stated without naming the jurisdiction
Having read the draft monograph on DSIP, the respondent puts one point to the committee.
The draft states that the compound is approved, or not approved, without saying by whom. The respondent, employed by a health-technology assessment body, states that approval status differs between jurisdictions for several compounds in the series and that an unqualified statement will be wrong somewhere.
The respondent proposes that every status statement name the authority and carry the date on which the status was checked.
The secretariat accepts this submission. An unattributed status statement is a claim the Institute cannot support.
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.
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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