BASIL-3 - resumption of randomisation

09 August 2019

​Please find attached the latest advice from the FDA on the paclitaxel issue, which includes a link regarding the recent Lutonix, the US Food and Drug Administration (FDA) denial which can be found here

BASIL-3 recruitment was paused in December 2018 in response to the Katsanos publication, however following advice from MHRA, and due process involving NIHR HTA and all of the stakeholders over the last few months, we are on course to 'un-pause' (resume recruitment to) BASIL-3 in September 2019.  Details of the trial can be found here and here

Based on the aggregate data we have so far on the 411 patients who had been randomised at the time we paused recruitment in December 2018, our statistical colleagues tell us that, maintaining 90% power and a minimum of 2 year follow-up (as per the original protocol), we will probably need just short of 500 patients to answer the original question.

In addition, in concordance with advice from MHRA (and FDA), we are discussing with NIHR HTA, and other stakeholders, the possibility of extending follow-up to a minimum of 5 years (to look at the late mortality).

As further evidence of the global importance of completing BASIL-3, the FDA have very recently been in touch with BSIR directly regarding a data sharing agreement in due course.  We will be discussing their approach and proposals at our next TMG meeting in September.

 

Posted 9th August 2019

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