Consultation record
Submissions accepted in part — page 12
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 12 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-COA-COMPLETE/008 | Draft synthesis: Completeness of certificates of analysis in the… | Dr Theodora Ximenes industry | A sponsor trial meeting the eligibility criteria was excluded |
| DRAFT-COA-COMPLETE/005 | Draft synthesis: Completeness of certificates of analysis in the… | Dr Quintus Kettlewell | The document is unreadable without specialist training |
| DRAFT-COA-COMPLETE/004 | Draft synthesis: Completeness of certificates of analysis in the… | Dr Ottoline Oppenheimer-Ade | The review protocol is described but its registration record is not linked |
| DRAFT-COUNTERION-C/008 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Georgiana Mountstephen | References should carry a persistent identifier for every cited source |
| DRAFT-COUNTERION-C/010 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Jolyon Grünbaum-Sowande | Studies not published in English were excluded without assessment |
| DRAFT-COUNTERION-C/009 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Ludmila Tollemache industry | A sponsor trial meeting the eligibility criteria was excluded |
| DRAFT-COUNTERION-C/007 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Jolanta Uttridge | The review protocol is described but its registration record is not linked |
| DRAFT-COUNTERION-C/001 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Nadezhda Lavrentiev | The same concern is used to downgrade in two domains |
| DRAFT-COUNTERION-C/003 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Ngozi Zetterlund | Statistical heterogeneity is treated as though it measured clinical heterogeneity |
| DRAFT-COUNTERION-C/012 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Mordecai Bellingham-Ojo | Patient-reported outcomes are collected by the trials and not reported by the review |
| DRAFT-BPC-157-HUMA/001 | Draft synthesis: Human evidence for BPC-157 | Dr Anselm Mountstephen | Studies not published in English were excluded without assessment |
| DRAFT-GH-SECRETAGO/004 | Draft synthesis: Clinical evidence for growth-hormone secretagogues… | Dr Liesbeth Nyquist-Obiora industry | A sponsor trial meeting the eligibility criteria was excluded |
| DRAFT-RUSSIAN-REGI/011 | Draft synthesis: Nationally registered neuropeptides and the… | Dr Ndidi Ravensworth-Ilunga | A surrogate outcome is used as the anchor without validation evidence |
| DRAFT-RUSSIAN-REGI/002 | Draft synthesis: Nationally registered neuropeptides and the… | Hortensia Beauchamp-Ekong | Two included studies do not meet the registered eligibility criteria |
| DRAFT-RUSSIAN-REGI/004 | Draft synthesis: Nationally registered neuropeptides and the… | Dr Georgiana Zimmerthal | Statistical heterogeneity is treated as though it measured clinical heterogeneity |
| DRAFT-RUSSIAN-REGI/006 | Draft synthesis: Nationally registered neuropeptides and the… | Dr Frideswide Hazelrigg | Studies not published in English were excluded without assessment |
| DRAFT-RUSSIAN-REGI/014 | Draft synthesis: Nationally registered neuropeptides and the… | Nkechi Larsson-Ekwueme | Regulatory assessment documents were not searched |
| DRAFT-RUSSIAN-REGI/016 | Draft synthesis: Nationally registered neuropeptides and the… | Dr Rurik Underhill-Okafor | The document is unreadable without specialist training |
| DRAFT-SPONSOR-COND/004 | Draft synthesis: The consequences of a wholly sponsor-generated… | Dr Anselm Mountstephen | The same concern is used to downgrade in two domains |
| DRAFT-SPONSOR-COND/001 | Draft synthesis: The consequences of a wholly sponsor-generated… | Dr Yolanda Norrington-Bhatt | Patient-reported outcomes are collected by the trials and not reported by the review |
| DRAFT-SPONSOR-COND/006 | Draft synthesis: The consequences of a wholly sponsor-generated… | Sigrún Vercingetorix | A surrogate outcome is used as the anchor without validation evidence |
| DRAFT-SPONSOR-COND/003 | Draft synthesis: The consequences of a wholly sponsor-generated… | Dr Wilhelmina Oppenheimer-Ade | The document is unreadable without specialist training |
| DRAFT-SURROGATE-OU/002 | Draft synthesis: Percentage weight change as a surrogate outcome | Yusuf Whitmarsh-Obi | The choice of effect measure is not justified and changes the appearance of the result |
| DRAFT-SURROGATE-OU/004 | Draft synthesis: Percentage weight change as a surrogate outcome | Quentin Gwynne-Sarpong | Subgroup findings are reported that were not registered in the protocol |
| DRAFT-SURROGATE-OU/008 | Draft synthesis: Percentage weight change as a surrogate outcome | Dr Katarzyna Yorkstone | Point estimates are given without an interval |
| DRAFT-AMYLIN-ANALO/005 | Draft synthesis: Amylin analogues as monotherapy and in combination | Dr Ilona Mbatha-Fredriksen | Subgroup findings are reported that were not registered in the protocol |
| DRAFT-AMYLIN-ANALO/009 | Draft synthesis: Amylin analogues as monotherapy and in combination | Dr Séverine Oduya-Kaltenbrunner | The same concern is used to downgrade in two domains |
| DRAFT-AMYLIN-ANALO/003 | Draft synthesis: Amylin analogues as monotherapy and in combination | Dr Stellan Cholmondeley-Ade | The choice of effect measure is not justified and changes the appearance of the result |
| DRAFT-AMYLIN-ANALO/001 | Draft synthesis: Amylin analogues as monotherapy and in combination | Ms Rhiannon Okoye-Vandergraaf | Point estimates are given without an interval |
| DRAFT-RECONSTITUTI/003 | Draft synthesis: Reconstitution practice and delivered dose | Dr Sigrún Lavrentiev | The document is unreadable without specialist training |
page 12 of 13