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.
RWE Multivariate Analyses
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Hi Jennifer - Under the Guidance documents pertaining to KM Analyses (Provision 8 ) and/or Real World Evidence (s1.4), would PAAB accept retrospective studies that use multivariate analyses to identify prognostic factors associated with Overall Survival?
Hello @alee
Provision 8 of the Guidance Document for Claims Based on Kaplan Meier Analysis does not apply to retrospective studies. The Guidance on Real-World Evidence/Data is intended for RWE/D and does not apply to (Kaplan-Meier analyses in) randomized, controlled trials. The use of multivariate analyses to identify prognostic factors associated with overall survival pertaining to a drug product may provide insights for future investigation but it also creates implications for subgroups with specific patient/disease characteristics that would not be acceptable in the absence of pre-planned evaluation of these subgroups (s. 1.4 of the Guidance on Real-World Evidence/Data for RWE/D and s. 3.1.1 of the PAAB Code for randomized, controlled trials).
