Replies to post #38589 on NorthWest Biotherapeutics Inc (NWBO)

[beachlifeisfun]

PERFECT! You they recruited at King's College even earlier! Since:

Providers are asked to publish details of the length of time taken to approve clinical trials from the point at which NHS Permission is applied for through to the recruitment of the first participant. This period is known as the initiation stage and the NIHR has assigned a benchmark target of 70 days.

Aug 12: Northwest Biotherapeutics has received approval from the MHRA for the Company´s PIII trial of DCVax-L to proceed in the UK. The trial is already underway at 40+ sites in the US. The trial has been approved by the UK National Research Ethics Committee. The study (NCT00045968) is enrolling 300 patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumour. They will receive the standard of care, including radiation and temozolomide therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm on documented disease progression. The primary endpoint is progression free survival. Overall survival is a secondary endpoint. Historically patients with newly diagnosed GBM show a median time to progression of about 8-9 months with median survival of 15-16 months. Immunization starts following primary therapy and will be given at weeks 0, 2 and 4 and at months 2, 4, 8 and 12, 18, 24 and 30.?The study started in Dec 2006 and primary outcome data are expected by Jun 13 [9,10].
25/08/2012 19:01:09

NHS permission was granted in August of 2012+260 days from the link that AVII posted


So, if you are saying that this mandate is site specific, then University College of London recruited their first patient into the trial sometime in the first half of 2013 AND King's College also did the same...because no matter how you figure it...the above quotes are very clear. (bolding, and color mine)

[Ready4bluesky]

Thanks for clarifying. I still wonder why it was so long for recruitment of the first patient at this site after approval of the application.

There have been a few sites added recently in the US. Should we expect they will begin treating their first patients next May? If so, I guess I won't be surprised when the projected date to reach full enrollment is once again moved back another year.