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As RWE may include PRO collection but RWE sometimes does not have a strict blinded study design - would it disqualify RWE PROs from inclusion in APS? I notice the checklist states "should be" conducted in a blinded study design.

I have read existing Q&A on samples.
I would like clarity on what PAAB considers a 'simple' sample availability message that would be PAAB exempt.

Would this be considered a 'simple' message? New Sample Program, Brand X samples now available at Company X. If interested, contact your company representative.

There would be no additional embellishments such as taglines or claims of merit on the product.

@jennifer-carroll A clarifying question, may I ask what is meant by "creating a reprint holder for a RWE study?"
What copy would potentially appear on this "holder"? Would it be all requirements from Section 2 of the PAAB RWE guidance?

Would the "reprint holder" be applicable to virtual distribution?

Hi PAAB,

As per the new RWE Guidance document, presentation of results from RWE must be informational and claim neutral. This can be done when RWE is presented within a specific APS material but not sure how this requirement would apply if an RWE reprint would be distributed by Sales Reps.

If an RWE paper is consistent with the TMA and meets all other requirements in section 1 of the RWE guidance. Can Sales Reps proactively distribute the reprint given language within it will NOT be informational and claim neutral? Would the answer differ if it is distributed by Reps in non-promotional vs. promotional manner?

Would like some clarity to ensure my understanding of consistency with TMA is correct in relation to the patient population attribute.

Example: Drug X is indicated for Disease Y. The pivotal trial for this indication only included patients with stable metastases Z. It excluded (exclusionary criteria) patients with active metastases Z. However, the indication for Drug X does not specify any restrictions with use of Drug X in those with Disease Y and active metastases Z.

Would an RWE paper where the overall patient population consists of patients with stable AND active metastases Z be considered not consistent with the the TMA?

The overall study population is not "exceeding the product’s indication" (wording taken from PAAB RWE guidance) but it is exceeding the patient population of the pivotal trial which resulted in the indication for Drug X.

Could a Phase 3b/4 study be considered under the RWE guidance? or under the Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising?

Can PAAB provide clarity on requirements for inclusion of patient cases in a branded HCP tool?

I understand there is a decision tree tool uploaded by PAAB titled "Guidance on which HCP materials require PAAB review."

However the response to PAAB Q&A 763 appears to conflict with the tool.

The tool allows for materials that discuss drug therapy or content relating to drug therapy to be PAAB exempt (if you follow the path to the end).
However, the response in Q&A 763 states that disease info materials that mention treatment by name class or category are not PAAB exempt.

Can you please clarify? The Decision Tree makes it seem that these materials are PAAB exempt but the Q&A question states otherwise.

My understanding is the Decision Tree is for any HCP materials which would include unbranded materials. It would be great to see the decision tree updated.