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.
