Consultation record

Submissions accepted in part

Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined.

Submissions

377 documents · page 1 of 13

Table 1. Submissions with this disposition, on this page.

Reference	Consultation	Respondent	Point raised
DRAFT-CERTAINTY-FR/004	Draft revision of the Institute’s certainty assessment framework…	Dr Katarzyna Oppenheimer-Ade	The database set omits sources relevant to the compounds in scope
DRAFT-CERTAINTY-FR/006	Draft revision of the Institute’s certainty assessment framework…	Dr Kamila Ubertini	Automated assistance in screening should be disclosed and validated
DRAFT-CERTAINTY-FR/002	Draft revision of the Institute’s certainty assessment framework…	Dr Anselm Ashworth-Danquah	The treatment of sponsor-conducted evidence is unworkable where all the evidence is…
DRAFT-CERTAINTY-FR/010	Draft revision of the Institute’s certainty assessment framework…	Dr Ottoline Oppenheimer-Ade	The conditions for upgrading observational evidence are too permissive
DRAFT-SUPPLIER-RUB/001	Draft supplier evaluation rubric	Dr Adaeze Dunmore-Ekpo	Scores are reported to a precision the underlying judgements do not support
DRAFT-SUPPLIER-RUB/003	Draft supplier evaluation rubric	Dr Rosalind Grünbaum-Sowande	Point estimates are given without an interval
DRAFT-COA-MINIMUM-/009	Draft certificate-of-analysis minimum data standard	Dr Quintus Rautavaara	Nothing requires a laboratory to demonstrate ongoing performance
DRAFT-COA-MINIMUM-/010	Draft certificate-of-analysis minimum data standard	Dr Gervase Crickhowell	Nothing in the standard addresses transfer of the method between laboratories
DRAFT-COA-MINIMUM-/004	Draft certificate-of-analysis minimum data standard	Zdenka Ximenes	Results are reported without an estimate of measurement uncertainty
DRAFT-COA-MINIMUM-/005	Draft certificate-of-analysis minimum data standard	Dr Hamish Nyquist-Obiora	References should carry a persistent identifier for every cited source
DRAFT-COA-MINIMUM-/011	Draft certificate-of-analysis minimum data standard	Vittoria Quintanilha	Acceptance criteria are expressed in terms specific to one instrument family
DRAFT-RP-HPLC-PURI/005	Draft standard: determination of chromatographic purity by…	Dr Wilhelmina Quaresma	Nothing in the standard addresses transfer of the method between laboratories
DRAFT-RP-HPLC-PURI/003	Draft standard: determination of chromatographic purity by…	Dr Eamon Sandringham-Adu industry	The additional determinations required would materially increase release testing cost
DRAFT-SEMAGLUTIDE-/011	Draft monograph: semaglutide, version 3	Dr Prosper Vercingetorix	Trials are described as terminated where they completed as planned
DRAFT-TIRZEPATIDE-/006	Draft monograph: tirzepatide, version 2	Dr Jolyon Grünbaum-Sowande	The document is unreadable without specialist training
DRAFT-TIRZEPATIDE-/010	Draft monograph: tirzepatide, version 2	Dr Hyacinth Oyelaran-Steen	Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome…
DRAFT-TIRZEPATIDE-/002	Draft monograph: tirzepatide, version 2	Rosalind Petrossian	The analytical section is longer than the clinical assessment it accompanies
DRAFT-TIRZEPATIDE-/007	Draft monograph: tirzepatide, version 2	Dr Dmitri Nordhagen	References should carry a persistent identifier for every cited source
DRAFT-WEIGHT-REGAI/007	Draft synthesis: weight change after discontinuation of an incretin…	Dr Anselm Ashworth-Danquah	Studies not published in English were excluded without assessment
DRAFT-WEIGHT-REGAI/012	Draft synthesis: weight change after discontinuation of an incretin…	Dr Ottoline Oppenheimer-Ade	The choice of effect measure is not justified and changes the appearance of the result
DRAFT-WEIGHT-REGAI/001	Draft synthesis: weight change after discontinuation of an incretin…	Dr Anselm Thorsby-Nakamura industry	A sponsor trial meeting the eligibility criteria was excluded
DRAFT-WEIGHT-REGAI/003	Draft synthesis: weight change after discontinuation of an incretin…	Dr Mordecai Glendinning-Uche	Two included studies do not meet the registered eligibility criteria
DRAFT-WEIGHT-REGAI/010	Draft synthesis: weight change after discontinuation of an incretin…	Dr Theodora Trelawney	A surrogate outcome is used as the anchor without validation evidence
DRAFT-NETWORK-TRAN/007	Draft methodological review: transitivity in the incretin network	Dr Wilhelmina Erlingsson	The document is unreadable without specialist training
DRAFT-NETWORK-TRAN/006	Draft methodological review: transitivity in the incretin network	Dr Gervase Crickhowell	The review protocol is described but its registration record is not linked
DRAFT-NETWORK-TRAN/008	Draft methodological review: transitivity in the incretin network	Dr Adaeze Dunmore-Ekpo	Point estimates are given without an interval
DRAFT-CONFLICTS-PO/006	Draft conflicts-of-interest policy	Dr Jolyon Grünbaum-Sowande	The document is unreadable without specialist training
DRAFT-CONFLICTS-PO/007	Draft conflicts-of-interest policy	Dr Dmitri Nordhagen	The secretariat answers submissions and is not itself named
DRAFT-CONFLICTS-PO/012	Draft conflicts-of-interest policy	Dr Amara Vandergraaf	Point estimates are given without an interval
DRAFT-CONFLICTS-PO/008	Draft conflicts-of-interest policy	Dr Liesbeth Quenneville	A party criticised in an assessment should have a right of reply

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