Author : Neal Caminsky


If our company is displaying at a conference are we allowed to have unbranded tools that have information on the disease state while at the same time having branded information available (Ie dose cards etc) for delegates? When you link branded and unbranded, everything becomes branded. Having both a branded tool and an unbranded tool […]


We are exploring the use of a 5 year extension study in branded APS that is not included in the sponsor’s TMA. This is an extension of the original study included in the sponsor’s TMA. If the only methodological discrepancy from the initial pivotal trial is that the primary endpoint of PFS in the extended […]


In a virtual delegate bag, provided to HCP’s at conferences are we able to include an invitation to a sponsored symposium or talk? Where am I able to find the criteria for delegate bag inserts? There are no “specific” criteria for delegate bag inserts. When creating a delegate bag insert, one should consider: What is […]


This question relates to PAAB code 3.2.3 (information on ongoing trials) Q1: Can you please confirm the elements that can be included in an APS – Study design, objectives, endpoints? Q2: We are assuming that when the code states ‘ongoing’ it means prior to an NOC which includes a trial that is no longer recruiting […]


A primary endpoint is stratified by multiple parameters, as stated in the TMA. Would it therefore be acceptable to include the subgroup analysis results for these parameters in advertising (Forest plot) from the published study, assuming they are statistically and directionally consistent with the overall primary endpoint result? There are many considerations in the assessment […]

Retour en haut