Unauthorized Use of Content on this Site: The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB)—including, but not limited to, those available through the PAAB Forum, the PAAB website, and any PAAB correspondence—are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content, or using it for model training or any related purposes, is strictly prohibited without the express prior written consent of PAAB. This includes, but is not limited to, the use of such materials in automated systems, machine learning models, or artificial intelligence applications.
RWE Multivariate Analyses
-
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).
