Title: Recruitment
1Funded by the MRC
AUTOLOGOUS CHONDROCYTE TRANSPLANTATION/IMPLANTATIO
N VERSUS EXISTING TREATMENTS
ISCRCTN 48911177
NEWSLETTER June 2009 Issue 17
- Recruitment the final push!
- ACTIVE has had a long gestation period and an
even longer period of labour but now for the
delivery - June is upon us which means we only
have seven months left to recruit over 100
patients. And we have even less time to convince
the MRC that this will happen because another
review is due in October. So, its time to pull
out all the stops and make the most of this
opportunity while the funding is still there to
treat patients. 13 centres (listed below) have
contributed this year. James Richardson here at
Oswestry, Venkat Satish at Swindon and Tony
Bhuller at Peterborough have been the best
recruiters this year but theres still time for
others to catch up. Stanmore is now ready for
referrals so if you have difficulties recruiting
please consider sending your patients there! - New centres
- The Nuffield Orthopaedic Centre, Oxford with PI
Andy Price has been set up in record time to join
ACTIVE so I eagerly await recruitment starting
there. Exeter surgeons Peter Schranz and Vipul
Mandalia are nearly set-up ready to start. At
Sunderland Shaun OBrien is in the process of
joining. Trusts can claim extra support costs for
ACTIVE from their Comprehensive Local Research
Networks and this is helping the set-up process
since RD - departments are keen to recruit into such studies.
Wolverhampton finally got departmental agreement
to join ACTIVE last week after waiting 3 years!
Thanks to RD and PI Mr Chugh for not giving up
as it sounds like they have quite a few patients
to recruit.
Number of patients randomised 29.05.09 Total 285
Help at handWhat has happened to recruitment at
Stockport, Hillingdon, St. Marys, Bath and York
where everything should be in place for
recruitment to happen? Throughout the trial I
have generally been impressed with the amount of
enthusiasm and effort centres have made and I
appreciate the difficulties of finding eligible
patients. However, there is always room for
extra effort so please dont hesitate to contact
me at the Trial Office if you need any help with
recruitment. I am happy to visit, and can give
presentations to increase awareness about ACTIVE
among your colleagues. Or perhaps staff need a
refresher on how to recruit patients and put them
through the trial? James Richardson is also
happy to provide advice just give him a ring
(01691 404386) or email james.richardson_at_rjah.nhs.
uk
PTO
2UK-ICRS Meeting The UK-ICRS meeting took place in
January at the RNOH, Stanmore. Led by Prof. Dave
Marsh and Prof. George Bentley, this
well-attended event generated much stimulating
discussion between scientists and surgeons. We
heard the latest from scientists working with
stem cells pondered on how best to measure
outcomes discussed strategies for further
research and generally got carried away by all
the exciting possibilities! One thing which was
obvious though, ACTIVE has really helped create a
collaborative network essential for undertaking
large-scale research into cartilage repair.
However, we need to complete ACTIVE by getting
sufficient numbers to address the primary
question (is cell grafting better than standard
surgery?) if we want to get funding for more
large-scale clinical research in the future.
Follow-up of Patients We are pleased to say that
data collection is going well and that most
patients are completing their follow-up
assessments. So far over 90 patients have
completed 2-year follow-up over 70 have
completed 3-year follow-up and 17 have completed
4-year follow-up. Generally we are finding that
patients who complete their assessments in the
first 12 months also comply well with 2-4 year
follow-up. So it seems the first 12 months is
critical for encouraging patients to stay in the
trial. Even if they appear to drop out we dont
like to give up - this week a patient returned a
completed 2-year questionnaire having not done
any of the assessments since 3-months follow-up.
Input/return of completed data Samantha sends
monthly reminders to let staff know when
assessments are due. If patients fail to turn up
or cant be contacted then please remember to let
Sam know so that she can help track the patient
down before the assessment is overdue. It is
also helpful if co-ordinators/assessors can input
data or post data to us before the end of each
quarter which means by the end of June for this
quarter so that Sam can calculate what payments
are due to you or your Trust. Patient
newsletter Its important to give a big thank-you
to the patients who contribute their time and
effort into ACTIVE. Having had failed
conservative and surgical treatments many are
truly motivated by the desire to improve
treatments for others and may not realise just
what an important contribution they each make to
the overall success of the trial. One way to
thank them is through newsletters and I am always
looking for material to go in another patient
newsletter maybe one of your patients would
like to share his/her experiences? Weve had
good feedback from the previous patient
newsletters but sadly we struggle to get material
for the next one. Thank you. Best wishes,
Heather Smith ACTIVE Trial Manager Heatherj.smit
h_at_rjah.nhs.uk Tel 01691 404142