persephone - university of warwick · healthcare at home ltd. it also permits sites to treat...
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Persephone Newsletter Issue 30
March 2014 Duration of Trastuzumab with chemotherapy in patients with early stage breast cancer: Six months versus Twelve
March is definitely a female month. It is pampering women with
celebrations of International Women’s day (8 March) and Mother’s
day (30 March). Indeed, we might add one more to this list. It turns
out France celebrates Grandmother’s day on the first Sunday of
March, which is 2nd March this year!
International Women's Day is a global day celebrating the
economic, political and social achievements of women past, present
and future since 1911. Check out your local activities from here:http://
www.internationalwomensday.com/. In some places like China, Russia,
Vietnam and Bulgaria, International Women's Day is a national
holiday.
Mother's Day (or Mothering Sunday in the UK) is a celebration
honouring mothers and motherhood, maternal bonds, and the
influence of mothers in society. It is celebrated on various days in
different parts of the world, most commonly in March or May. Most
historians believe that Mothering Sunday evolved from the 16th-
century Christian practice of visiting one's mother church annually on
Laetare Sunday. As a result of this tradition, most mothers were
reunited with their children on this day when young apprentices and
young women in service were released by their masters for that
weekend.
56 in Feb, 47 patients in Jan and 6 so far in March. Recruitment
is picking up as the amendments approvals are coming
through. 3210 patients have been accrued in total.
A total of 154 sites are now open with Royal Berkshire and
Milton Keynes Hospitals the latest sites to open to the trial.
We have now reached 80% of the recruitment target. Keep up
the good work. The oncology medical world is waiting for the
PERSEPHONE results !
“PERSEPHONE addresses an important question and one to
which the world is waiting for an answer”
Prof. Clark, Chair NICE Technology Appraisal Committee
Top recruiters (as of 20.02.14)
Addenbrooke's Hospital .................... 77
Peterborough City Hospital .............. 63
Norfolk & Norwich Uni Hospital ......... 59
Royal Sussex County Hospital ........... 59
St Bartholomew's Hospital ................. 54
Royal Derby Hospital .......................... 53
Southampton General Hospital ....... 53
Maidstone Hospital ............................. 51
Royal Liverpool University Hospital... 51
Southend Hospital .............................. 51
New Cross Hospital ............................. 50
Queen's Hospital (Romford) ............. 48
Wexham Park Hospital ....................... 48
Cumberland Infirmary ........................ 45
Christie Hospital ................................... 44
Luton and Dunstable Hospital .......... 43
Eastbourne District Gen Hospital ..... 42
Royal Shrewsbury Hospital ................ 41
Charing Cross Hospital ....................... 40
Royal Hampshire County Hospital ... 40
HAPPY WOMEN’S &
MOTHER’S DAY!
A special thanks to Royal
Sussex Hospital (RN Helen
Mitchell and Dr Bloomfield) who
have recruited 5 patients this
year. The team approached
their patients as usual but
randomised them to receive
the subcutaneous form just
after Amendment 11 was
approved at their site. Patients
were randomised at cycle 3, 3,
6, 7 and 8.
Do remember that patients can
be randomised up to cycle 10,
so most of the patients who
started Herceptin during or after
August remain eligible.
Recruitment News
Would you fancy showing off your art? A painting, photograph or maybe a
poem...Interested? Then please look at the penultimate page of this newsletter.
http://www.internationalwomensday.com/http://www.internationalwomensday.com/http://en.wikipedia.org/wiki/Motherhttp://en.wikipedia.org/wiki/Laetare_Sunday
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This is a very busy time for all the teams who are now implementing our two recent amendments (11 & 12 -
12 is just for H@H sites). So far, sites have been very reactive. 111 of the 154 participating sites and 8 of the 27
sites using Healthcare at Home Ltd have received approval for amendments 11 and 12, respectively. We are
very grateful for your active collaboration. If you have not received your approval(s) yet, please chase your
R&D department TODAY to be able to work with version 4.0 of the protocol ASAP.
Updated Incident Reporting Procedure: Recently, one of the PERSEPHONE sites experienced an
incident which was later reported to the MHRA as a Serious Breach of GCP. To ensure that incidents are
reported timely to the PERSEPHONE team, we have set-up a new procedure involving a Incident
Reporting Form that all PIs now need to acknowledge receipt of. So far only 89 of our 154 PI’s have
acknowledged the new procedure.
Please return the Incident Acknowledgment slip ASAP.
Amendment News
Amendment 11 includes:
a new protocol, version 4.0,
which is updated, clearer and in line with
standard practice.
allows use of the sub-cutaneous formulation of
trastuzumab
a new PIS updating patients on recent chang-
es.
REMEMBER: Patients randomised under
protocol 3.1 who switch to the sub-
cutaneous formulation must be
reconsented on PIS version 6.0.
Amendment 12 is about updating the MHRA on
the changes of manufacturing processes at
Healthcare at Home Ltd. It also permits sites to
treat PERSEPHONE patients while the contracts
between sites and H@H (Service Level Agree-
ment and Technical Agreement) which were in
place prior to the amendment are being amend-
ed.
Note: H@H is allowed to administer the sub-
cutaneous formulation provided that a Technical
Agreement was in place previously and that the
site has their Trust approval for amendment 11.
Implementing the amendment(s) also means that the new documentation must be
acknowledged by the site team and the site file must be updated ... For a smooth
amendment please go back to the tips listed in our previous Newsletter or contact us.
As part of this process, you should also complete and return the monitoring checklist(s)
Which were sent alongside the amendment documents.
What sites must return:
Trust approval for Amendment 11 +/- Amendment 12
Acknowledgement of the new Incident Report process by the PI
Checklist for the Site File to be signed by main contact
Checklist for the Pharmacy File to be signed by main pharmacy contact
Participating Site Agreement – New version of the Pharmacy Appendix
to be completed and signed by main pharmacy contact
A copy of all
these documents
should be filed in
the relevant
sections of your
PERSEPHONE
Site File.
Staff News
We are pleased to welcome on board 2 new
starters to manage the trial data:
Lisa Poulton started last October.
John Carey started in January and will be
helping for the foreseeable future.
Trial Coordinator Shrushma Loi will be return-
ing from maternity leave 6th March
Burcu Babaoglan Fiehler has been helping
with recent communication documents
Cardiac Safety Study Update
PERSEPHONE is an exceptional
trial in terms of its cardiac safety
monitoring. Persephone collects
detailed LVEF measurements
every 4 months during trastuzumab
treatment.
The trial statistician has begun analysing the
LVEF data in preparation for publication and
we will be contacting sites shortly with our
LVEF queries. To be able to finalise this
presentation, it is important that sites kindly
respond to these vital queries in a timely
fashion.
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PERSEPHONE has an excellent re-
turn rate of CRFs (94%) and the
team has been congratulated on
many occasions by the TSC and
DSMC for this. Thank you to all for
completing the CRFs so promptly.
Any unclear data is queried which creates a lot of
work for the data management team but also for
the sites completing the CRFs. To save time for all,
we have compiled a list of recurrent oversights
which automatically generates queries.
To prevent CRFs being returned to you in the form of
data queries, please carefully consider these tips:
Annual follow up CRF: Ticking ‘yes’ to one
drug and then leaving the rest blank (rather
than ticking ‘no’ or ‘NK’), will generate a que-
ry. Chemotherapy/ surgery – please don’t in-
clude relapse or new primary chemo/surgery.
Radiotherapy CRF: Ticking ‘yes’ to one treat-
ment site and leaving the rest blank rather
than ticking ‘no’ or ‘NK’), will generate a que-
ry. Please also write (in the margin with initials
and date) if the radiotherapy regimen is unu-
sual due to the patient being on a radiothera-
py trial (such as IMPORT high/low). This will pre-
vent us querying start dates and boosts.
Surgery CRF: The score for % stained cells or H or Q
score need to be completed, even if ER and/or
PGR status are/is negative, . Blank scores are
queried back to site.
Treatment CRFs:
Complete either the IV or sub-cut dose details
and not both!
If toxicity for either pain or infection is ticked
“Yes” the site of pain/infection also has to be
specified.
If there are more than 21 days between 2
doses, “delay” must be ticked and the reason
for the delay must be explained.
Do not repeat the same LVEF date on several
forms – it is needed only once.
For patients TNO 1-2500 we require a minimum
of 5 LVEFs for patients on both treatment arms.
If the last LVEF is abnormal we need it
repeating until it returns to normal.
Adverse Event Toxicity Grade 4 = a SAE for any
toxicity, if we haven’t had an SAE reported for
that toxicity it will be queried.
The main tip is remembering to initial and
date all changes on all forms (including
addition and deletion of data). Also, please
sign and print names so we don’t query who
has completed the CRFs. This person must be
on the Site Signature and Delegation Log.
Guidance for CRF Completion
The views and opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health
PERSEPHONE team
Trial Coordination (Warwick) Emma Ogburn
Shrushma Loi
Phone: 0247 615 0492
Phone: 0247 615 0492
Clinical Trial Administration (Warwick) Donna Howe [email protected] Phone: 0247 615 0600
Data Management (Warwick) Lisa Poulton John Carey
Phone: 0247 615 1665
Phone: 0247 615 1127
Pharmacovigilance & Pharmacy
(Cambridge) Anne-Laure Vallier [email protected]
Phone: 01223 348086
Translational Studies (Cambridge) Kevin Baker [email protected] Phone: 01223 348083
Would you like to publish your art/literature in Persephone and share with our readers?
If so, we would like to invite you to submit your art or literature to us . We welcome
submissions (poetry, short stories, photography, artworks, or comic strips) from anyone
who is affiliated in any way with Persephone.
To contribute , please contact us (see below).
Hope to hear from you!
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Dr Helena Earl
Emma Shrushma
Caroline
Donna
Louise
Sue
Kevin
Anne-Laure
Burcu
Anita
Louise
Prof Janet Dunn
John Lisa