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.
Patient case studies
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Are real patient case studies, used to illustrate before and after effects, which were not taken from the efficacy studies in the PM, acceptable in a branded piece?
Hello @charlton
A real patient case can be used when it can be supported by statistically significant pre-defined endpoints from a randomized control trial (RCT) (s3.1.3). The outcomes discussed should be consistent with the outcomes from the trial and within the limitations of the TMA (PM). Effects which are not directly supported by statistically significant data from a RCT, would not be acceptable. The patient case would be required to be disclaimed to be clear and complete.
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Thanks for your reply. However, I'm still not clear about whether the patient is required to have been one of the patients included in the trial included in the PM.
Hey @charlton
No, a patient case is not required to be on a patient who actually participated in the PM trial.
