Consultation record
Submissions accepted — page 2
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.
Submissions
735 documents · page 2 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-TIRZEPATIDE-/001 | Draft monograph: tirzepatide, version 2 | Dr Lorcan Zaleski-Mbeki | Local reactions are omitted from the adverse-event table because the trials reported them separately |
| DRAFT-TIRZEPATIDE-/002 | Draft monograph: tirzepatide, version 2 | Dr Ivo Quintanilha | Effect estimates are given without naming the comparator |
| DRAFT-TIRZEPATIDE-/003 | Draft monograph: tirzepatide, version 2 | Dr Eamon Immelmann | The analytical section assumes a reference standard that is not generally available |
| DRAFT-TIRZEPATIDE-/007 | Draft monograph: tirzepatide, version 2 | Dr Evander Ashworth-Danquah | The same concept is given three different names in one document |
| DRAFT-TIRZEPATIDE-/009 | Draft monograph: tirzepatide, version 2 | Dr Marisol Dunmore-Ekpo | Registered trials that never reported are absent from the monograph |
| DRAFT-TIRZEPATIDE-/010 | Draft monograph: tirzepatide, version 2 | Dr Valentin Tollemache | What happens to weight after the compound is stopped is not in the assessed outcomes |
| DRAFT-TIRZEPATIDE-/011 | Draft monograph: tirzepatide, version 2 | Dr Zdenka Ximenes | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-TIRZEPATIDE-/012 | Draft monograph: tirzepatide, version 2 | Quentin Whitmarsh-Obi | The compound is supplied under names the monograph does not list |
| DRAFT-BPC-157-MONO/001 | Draft monograph: BPC-157 | Dr Anselm Thorsby-Nakamura | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-BPC-157-MONO/002 | Draft monograph: BPC-157 | Dr Vasilisa Immelmann | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-BPC-157-MONO/004 | Draft monograph: BPC-157 | Dr Séverine Oduya-Kaltenbrunner | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-BPC-157-MONO/005 | Draft monograph: BPC-157 | Dr Quentin Zimmerthal | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-BPC-157-MONO/006 | Draft monograph: BPC-157 | Dr Melisande Kirkpatrick-Ola | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-BPC-157-MONO/007 | Draft monograph: BPC-157 | Dr Gervase Abergavenny | Preclinical findings are reported without the model that produced them |
| DRAFT-BPC-157-MONO/008 | Draft monograph: BPC-157 | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-WEIGHT-REGAI/002 | Draft synthesis: weight change after discontinuation of an incretin… | Dr Wojciech Kaltenbach-Mensah | An indirect comparison is presented without an assessment of transitivity |
| DRAFT-WEIGHT-REGAI/007 | Draft synthesis: weight change after discontinuation of an incretin… | Dr Vittoria Quintanilha | Risk-of-bias judgements are reported as an overall rating without the domains |
| DRAFT-WEIGHT-REGAI/009 | Draft synthesis: weight change after discontinuation of an incretin… | Dr Yusuf Whitmarsh-Obi | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-WEIGHT-REGAI/011 | Draft synthesis: weight change after discontinuation of an incretin… | Dr Ivo Quintanilha | The conclusion is stated more strongly than the certainty rating supports |
| DRAFT-WEIGHT-REGAI/013 | Draft synthesis: weight change after discontinuation of an incretin… | Dr Zdenka Nyquist-Obiora | Doses differing several-fold are pooled without examining dose-response |
| DRAFT-WEIGHT-REGAI/015 | Draft synthesis: weight change after discontinuation of an incretin… | Dr Wolfram Quintanilha industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-NETWORK-TRAN/001 | Draft methodological review: transitivity in the incretin network | Dr Vittoria Quintanilha | Results at materially different follow-up durations are pooled |
| DRAFT-NETWORK-TRAN/005 | Draft methodological review: transitivity in the incretin network | Dr Kolawole Isaksen-Balogun | Intention-to-treat and efficacy-estimand results are combined without distinction |
| DRAFT-NETWORK-TRAN/006 | Draft methodological review: transitivity in the incretin network | Dr Oisín Rautavaara | The timepoint at which each outcome was extracted was chosen after the data were seen |
| DRAFT-NETWORK-TRAN/007 | Draft methodological review: transitivity in the incretin network | Dr Jozef Brandvold-Achterberg | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-NETWORK-TRAN/008 | Draft methodological review: transitivity in the incretin network | Dr Piotr Hollingworth | Doses differing several-fold are pooled without examining dose-response |
| DRAFT-NETWORK-TRAN/009 | Draft methodological review: transitivity in the incretin network | Thaddeus Isaksen-Balogun | Overlapping primary studies across included reviews are counted more than once |
| DRAFT-CONFLICTS-PO/001 | Draft conflicts-of-interest policy | Professor Bartolomeu Nkosi-Lindegaard | Independence is asserted and the mechanism securing it is not described |
| DRAFT-CONFLICTS-PO/002 | Draft conflicts-of-interest policy | Dr Vasilisa Sandringham-Adu | What the site collects about a reader is not stated in terms a reader can check |
| DRAFT-CONFLICTS-PO/003 | Draft conflicts-of-interest policy | Dr Georgiana Mountstephen | Whether external reviewers are paid is not stated |
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