367-368 Comment: Proposed clarification highlighted in red font below. Proposed change: "... disproportionality statistics in paediatric patients versus adults (if applicable, depending on the size of the data set) can help to determine ..." 364-365 Comment: This statement should make a clear reference to GVP Module IX Addendum I on signalling (current draft). It should be clarified that routinely generated signalling reports from Eudravigilance include statistics of disproportionality in (paediatric and geriatric). GVP Module IX text should be completely aligned to this text. Proposal: As for the general population, statistics of disproportionate reporting (see GVP Module IX Addendum I) should be calculated using only ICSRs about paediatric patients to increase the ability to detect paediatric signals of disproportionate reporting (SDR) from appropriate spontaneous databases such as i.e. EudraVigilance. 367-369 Comment: Regarding the statement “comparison of the disproportionality statistics in paediatric patients versus adults can help to determine whether or not a suspected adverse reaction is likely to be more frequent in paediatric patients”, it would be useful to add more guidance under which assumptions the comparison may be valid and to acknowledge a potential for misuse or misinterpretation of disproportionality analysis if such comparison is used as a blanket approach without considering the reporting mechanisms that may contribute to
367-368 Comment: Proposed clarification highlighted in red font below. Proposed change: "... disproportionality statistics in paediatric patients versus adults (if applicable, depending on the size of the data set) can help to determine ..." 364-365 Comment: This statement should make a clear reference to GVP Module IX Addendum I on signalling (current draft). It should be clarified that routinely generated signalling reports from Eudravigilance include statistics of disproportionality in (paediatric and geriatric). GVP Module IX text should be completely aligned to this text. Proposal: As for the general population, statistics of disproportionate reporting (see GVP Module IX Addendum I) should be calculated using only ICSRs about paediatric patients to increase the ability to detect paediatric signals of disproportionate reporting (SDR) from appropriate spontaneous databases such as i.e. EudraVigilance. 367-369 Comment: Regarding the statement “comparison of the disproportionality statistics in paediatric patients versus adults can help to determine whether or not a suspected adverse reaction is likely to be more frequent in paediatric patients”, it would be useful to add more guidance under which assumptions the comparison may be valid and to acknowledge a potential for misuse or misinterpretation of disproportionality analysis if such comparison is used as a blanket approach without considering the reporting mechanisms that may contribute to
final-efpia-comments_gvp-module-iv-paediatric-population-12-oct_clean.docx