The PAVE Trial Management Group are seeking to appoint an independent statistician to sit on the Data Monitoring Committee (DMC) of PAVE (Paclitaxel assisted balloon Angioplasty of Venous stenosis in haemodialysis access).
We invite interested parties to send us a short CV detailing their experience, or to direct us to a webpage if this has relevant information.
This is a multicentre, double-blinded, randomised controlled trial, which aims to assess the efficacy of paclitaxel-coated balloons compared to placebo balloons in improving outcomes after fistuloplasty of stenotic arteriovenous fistulae in haemodialysis patients.
The Chief Investigator is Dr Michael Robson based at KCL/Guy’s Hospital, London. Participants will be randomised into either of the two treatments arms 1) fistuloplasty with a paclitaxel-coated balloon or 2) fistuloplasty with placebo uncoated balloon.
The DMC exists to provide independent monitoring and review of the trial, and will consist of three members; a statistician and two experienced clinicians, specialising in interventional radiology, renal medicine or vascular access surgery. The first meeting
of the DMC will be held jointly with the Trial Steering Committee (TSC) approximately 6 weeks before commencement of recruitment (total trial recruitment duration 22 months), and subsequent meetings will be held annually or as appropriately requested by the
DMC. It is expected that the first meeting will be face-to-face and following this, teleconferences are a possibility (there are provisions for travel expenses incurred). The DMC will be supplied with data on safety, accrual and data completeness, and will
be asked to comment on the progress of the trial and whether the accumulated data justifies continuing recruitment of patients to the trial. The findings and recommendations of the DMC will be reported to the Trial Management Group (TMG) and TSC. The trial
is co-sponsored by King’s College London and Guy’s and St. Thomas’ NHS Trust. This is an investigator-initiated and investigator led trial funded by the National Institute for Health Research via the Efficacy and Mechanism Evaluation programme.
If you are interested in the opportunity then please could you email your interest with a short CV or a link to your webpage to both Vikki Semik: [log in to unmask] (Trial Manager) and Michael Robson: [log in to unmask] (CI)
Many thanks
Vikki Semik | PAVE Trial Manager
King's College London MRC Centre for Transplantation 5th Floor | Southwark Wing Guy’s Hospital London | SE1 9RT
020 7188 1527 | [log in to unmask]
