Consultation record
Submissions accepted — page 8
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 8 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-ORFORGLIPRON/001 | Draft monograph: orforglipron | Dr Yusuf Whitmarsh-Obi | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-ORFORGLIPRON/003 | Draft monograph: orforglipron | Dr Anselm Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them |
| DRAFT-ORFORGLIPRON/004 | Draft monograph: orforglipron | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-ORFORGLIPRON/005 | Draft monograph: orforglipron | Dr Piotr Hollingworth | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-ORFORGLIPRON/006 | Draft monograph: orforglipron | Dr Dmitri Nordhagen | What happens when the compound is stopped is not addressed |
| DRAFT-ORFORGLIPRON/007 | Draft monograph: orforglipron | Dr Jolyon Grünbaum-Sowande | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-ORFORGLIPRON/008 | Draft monograph: orforglipron | Dr Vasilisa Sandringham-Adu | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-ORFORGLIPRON/009 | Draft monograph: orforglipron | Dr Fenella Lavrentiev | What happens to weight after the compound is stopped is not in the assessed outcomes |
| DRAFT-ORFORGLIPRON/010 | Draft monograph: orforglipron | Dr Wolfram Kaltenbach-Mensah | Glycaemic trials and weight-management trials are drawn on interchangeably |
| DRAFT-DANUGLIPRON-/001 | Draft monograph: danuglipron | Dr Yusuf Whitmarsh-Obi | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-DANUGLIPRON-/002 | Draft monograph: danuglipron | Dr Frideswide Nordhagen | Doses are expressed in units that differ between sections |
| DRAFT-METHODOLOGY-/002 | Draft methodology document, version 4 | Dr Anselm Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them |
| DRAFT-METHODOLOGY-/004 | Draft methodology document, version 4 | Thaddeus Isaksen-Balogun | Imprecision is judged against a relative threshold where an absolute one is what matters |
| DRAFT-METHODOLOGY-/006 | Draft methodology document, version 4 | Dr Marisol Dunmore-Ekpo | The rating conflates absence of evidence with conflicting evidence |
| DRAFT-METHODOLOGY-/007 | Draft methodology document, version 4 | Dr Yaa Kettlewell | The treatment of imprecision does not work where the event did not occur |
| DRAFT-METHODOLOGY-/008 | Draft methodology document, version 4 | Dr Jerome Petrossian | Interoperability with published certainty guidance must be preserved in any revision |
| DRAFT-METHODOLOGY-/009 | Draft methodology document, version 4 | Dr Ivo Quintanilha | The framework does not say what new evidence would change a rating |
| DRAFT-METHODOLOGY-/010 | Draft methodology document, version 4 | Dr Vittoria Quintanilha | The framework should say when a rating must not be issued at all |
| DRAFT-METHODOLOGY-/013 | Draft methodology document, version 4 | Dr Odalys Thorsby-Nakamura | Nothing states how many assessors rate a body of evidence |
| DRAFT-METHODOLOGY-/014 | Draft methodology document, version 4 | Dr Jozef Brandvold-Achterberg | The risk-of-bias instrument is not named, so a judgement cannot be reproduced |
| DRAFT-METHODOLOGY-/015 | Draft methodology document, version 4 | Professor Bartolomeu Nkosi-Lindegaard | It is not clear which provisions bind the assessment committee |
| DRAFT-METHODOLOGY-/019 | Draft methodology document, version 4 | Dr Melisande Kirkpatrick-Ola | Screening is described in terms that two people would apply differently |
| DRAFT-METHODOLOGY-/021 | Draft methodology document, version 4 | Dr Evander Ashworth-Danquah | Indirectness is defined so broadly that any evidence could be downgraded under it |
| DRAFT-SUPPLIERS-CO/001 | Draft supplier comparison table | Dr Rosalind Petrossian | A printed copy loses the information that makes it checkable |
| DRAFT-SUPPLIERS-CO/002 | Draft supplier comparison table | Eamon Sandringham-Adu | A withdrawn document should not simply disappear |
| DRAFT-SUPPLIERS-CO/003 | Draft supplier comparison table | Dr Frideswide Nordhagen | A printed copy loses the document identifier |
| DRAFT-SUPPLIERS-CO/004 | Draft supplier comparison table | Quentin Whitmarsh-Obi | The citation format offered cites the document and not the part |
| DRAFT-SUPPLIERS-CO/005 | Draft supplier comparison table | Dr Quentin Gwynne-Sarpong | Indications for which compounds are supplied are absent from the set |
| DRAFT-SUPPLIERS-CO/011 | Draft supplier comparison table | Professor Bartolomeu Nkosi-Lindegaard | The identifier encodes the document type, which is a property that can change |
| DRAFT-SUPPLIERS-CO/012 | Draft supplier comparison table | Dr Oisín Rautavaara | The same quantity is rounded differently in two parts of one document |
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