766 - Can you confirm if a CSR (Clinical Summary Report) is an acceptable document to support a data presentation from a published clinical trial. For example, the published clinical report presents pooled data results but the CSR captures this same endpoint by individual pivotal studies which garnered NOC for the drug. Additionally, can client share a portion of the document rather than the entire document given these reports are typically 2000+ pages. If it is possible to submit a partial version of the report, please confirm what parameters should be considered. thank you.
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Pooled data generally does not meet PAAB Code evidence requirements. Code section 3.1.1 states “Clinical/therapeutic claims must be based on published, well-controlled and/or well-designed studies with clinical and statistical significance clearly indicated. Publication in peer-reviewed journals is usually a good criterion for establishing scientific rigor. Review articles, pooled data, meta-analysis and post-hoc analysis are generally regarded as not being high level evidence to support claims in drug advertising. Non-clinical claims must be well supported by evidence". Additionally, as per code section 3.1.2, data on file (e.g. CSR) can only be used to clarify existing data, not to present new data. Section 3.3 states that “References cited in the APS must be available to health professionals on request…A copy of the summary of the Data on File must be provided to health professionals upon request” however, this is upon request. Summaries of data on file should not be distributed in an unsolicited manner.
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Pooled data generally does not meet PAAB Code evidence requirements. Code section 3.1.1 states “Clinical/therapeutic claims must be based on published, well-controlled and/or well-designed studies with clinical and statistical significance clearly indicated. Publication in peer-reviewed journals is usually a good criterion for establishing scientific rigor. Review articles, pooled data, meta-analysis and post-hoc analysis are generally regarded as not being high level evidence to support claims in drug advertising. Non-clinical claims must be well supported by evidence". Additionally, as per code section 3.1.2, data on file (e.g. CSR) can only be used to clarify existing data, not to present new data. Section 3.3 states that “References cited in the APS must be available to health professionals on request…A copy of the summary of the Data on File must be provided to health professionals upon request” however, this is upon request. Summaries of data on file should not be distributed in an unsolicited manner.
Good afternoon @jennifer-carroll! Point well taken about the circumstances under which a CSR can be used as evidence, but what about the second part of this question? If we able to submit a partial version of the report, can you confirm what parameters should be considered? Thanks!
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Good afternoon @jennifer-carroll! Point well taken about the circumstances under which a CSR can be used as evidence, but what about the second part of this question? If we able to submit a partial version of the report, can you confirm what parameters should be considered? Thanks!
Hey @constance
Due to their size, we often receive a portion of the report. The advertiser must include any content that is relevant to the APS presentation in question.
