NorthWest Biotherapeutics Inc (NWBO)

[Ready4bluesky]

Check this out! From a UK clinical trial for elective abdominal aorta aneurysm (AAA) repair. This research article was just published on August 25th. The patient recruitment section is of particular interest. Maybe a temporary suspension is mandatory UK NIHR protocol during an interim analysis.

http://www.trialsjournal.com/content/16/1/377

Results
Patient recruitment
In total, 98 patients were referred for an elective AAA repair (71 EVAR and 27 open procedures) during the 2-year study period from 1 January 2011 to 31 December 2012. Of these, 93 were screened for inclusion and 85 (91 %) were eligible to take part. Fifteen eligible patients were not approached for the trial:

1. Three because the surgery was cancelled (patients with significant co-morbidities where consultation at the multi-disciplinary team meeting and patient choice led to the decision not to proceed).

2. Six for logistical reasons (staff shortage; initially not enough backup when study principal investigator (PI) was absent).

3. Six because the trial in patients undergoing an EVAR procedure was temporarily suspended while the results of an interim analysis was reviewed.

And once again Les's statement:

"The only change is that new screening of patient candidates is temporarily suspended while we submit certain trial information for regulatory review."