Forum Update: Supporting Community-Led Discussion
The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.
Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:
- Correct any misunderstandings
- Provide guidance when questions remain unanswered after a few days
- Support discussions where official clarification is needed
Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.
Thank you for being part of the conversation.
Use of descriptive statistics
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Can trials that use descriptive statistics for their statistical methods be considered in a promotional setting (unbranded or branded)? If trials that use descriptive statistics can be used in APS, what are the considerations for use i.e. disclosures, limited to only one setting?
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Can trials that use descriptive statistics for their statistical methods be considered in a promotional setting (unbranded or branded)? If trials that use descriptive statistics can be used in APS, what are the considerations for use i.e. disclosures, limited to only one setting?
Descriptive statistics alone, may not be used to support promotional claims. Depending on the data, we may consider presentation in an informational, claim neutral context. Applicability of icons, formatting or disclosures would depend on the study design, endpoints, etc. We are unable to provide specifics without seeing the data and proposed APS. We suggest our opinion service if further direction is required.
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Descriptive statistics alone, may not be used to support promotional claims. Depending on the data, we may consider presentation in an informational, claim neutral context. Applicability of icons, formatting or disclosures would depend on the study design, endpoints, etc. We are unable to provide specifics without seeing the data and proposed APS. We suggest our opinion service if further direction is required.
@jennifer-carroll Thank you for your response. As a follow up question, in the context of an RWE publication, would the use of descriptive statistics to evaluate clinical outcomes preclude the use of the publication in a tool? Assuming that the analysis and endpoints were prespecified.
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@jennifer-carroll Thank you for your response. As a follow up question, in the context of an RWE publication, would the use of descriptive statistics to evaluate clinical outcomes preclude the use of the publication in a tool? Assuming that the analysis and endpoints were prespecified.
Hey @cchristopoulos
Descriptive statistics in an RWE do not preclude the use of the publication in an APS as long as they are pre-specified.
