Memorandum submitted by the Royal College
of Paediatrics and Child Health (SAGE 20)
Our comments relate to the first case study:
Swine Flu pandemic in 2009.
The Royal College of Paediatrics and Child Health
believes that the response to the H1N1 pandemic with regard to
the production of vaccine and the stock piling of Tamiflu was
appropriate. The CMO had to act assuming the worst case scenario.
The papers published from Australia and the US had shown that
this flu was very virulent with a high mortality, particularly
among the young. However, it proved to be less transmissible than
had been predicted and numbers of affected cases were therefore
less than expected. It is conceivable, if not likely, that a H1N1
pandemic will recur at some point; in this respect, the response
may represent a very good dress rehearsal.
NATIONAL INSTITUTE
FOR HEALTH
RESEARCH (NIHR) MEDICINES
FOR CHILDREN
RESEARCH NETWORK
(MCRN) SUPPORT FOR
DEPARTMENT OF
HEALTH PRIORITY
SWINE FLU
TRIAL
In September/October 2009, constituent parts
of the NIHR worked together to support a key study comparing the
Baxter H1N1 vaccine and GlaxoSmithKline H1N1 vaccine in children
six months to 12 years of age. The study was funded by Health
Technology Assessment and the Lead Applicant was Professor Liz
Miller, Health Protection Agency, and the Chief Investigator was
Professor Andrew Pollard, University of Oxford.
Usually such studies take many months, even
years, to develop from an agreed protocol through regulatory and
ethical approvals (both national and at each local participating
site), recruitment of staff, then participants and completion
of the study. In the context of the H1N1 pandemic, the Department
of Health gave high priority to relevant H1N1 studies and the
relevant governance bodies fast-tracked their approvals assessments
as a result. The NIHR had in the summer of 2009 made contingency
plans to allow the research networks to support priority H1N1
studies.
In this case, the trial was a collaboration
between the lead site, The Oxford Vaccine Group at the University
of Oxford, Centre for Infections at the Health Protection Agency
and other sites, namely: St George's Vaccine Institute, London,
University of Southampton, Wellcome Trust Clinical Research Facility,
Bristol Children's Vaccine Centre, and Royal Devon and Exeter
NHS Foundation Trust. The study was adopted into the NIHR MCRN
Portfolio following review by the MCRN Study Assessment Committee
which was completed within 48 hours.
Research staff within the MCRN Local Research
Networks (LRNs) and Comprehensive Local Research Networks (CLRN)
were mobilised to undertake this study. Support from senior management
within participating Trusts facilitated access to Trust resources
to ensure swift and efficient study set up and running (eg pharmacy,
Research & Development, laboratories, space in Out Patients,
PALS, security, cleaning, Finance, HR, Public Relations departments).
This trial required the recruitment and follow-up
of a large number of study participants (see Table 1) within a
short time frame (one month for recruitment). This was achieved
by close collaboration between the study team and (C)LRN-funded
staff during an intense recruitment period when children and families
were recruited outside normal working hours. Key to success was
the ability to achieve approvals and training (eg nurse contracts
and training) to allow staff to work in new sites or facilities
(eg schools, primary care sites) to facilitate recruitment, vaccination
and follow-up. As a result of this tremendous collaboration, recruitment
to the study was not only fully achieved but in a very short period
of time. This is unprecedented in a complex research study involving
so many children. As a result of this study, the Department of
Health was able to institute a timely and evidence-based vaccination
programme for children.
Table 1
RECRUITMENT TO THE TRIAL
| Site | LRN/area
| Recruitment |
| Oxford | South Central Area
| 275 |
| Southampton | South Central Area
| 277 |
| St Georges | SENCE | 133
|
| Bristol | SWEST | 255
|
| Exeter | SWEST |
|
| |
|
DEPARTMENT OF
HEALTH GUIDANCE
The RCPCH is committed to ensuring that all advice to Paediatricians
during a Swine Flu pandemic is evidence-based, appropriate and
consistent, in order to best serve the interests of children and
young people.
During the recent Swine Flu emergency, the Department of
Health issued some helpful guidance for paediatric services. The
use of algorithms was particular helpful. However, at the time
the College had concerns that the Swine Flu paediatric hospital
pathway did not make clear under which circumstances the advice
should be followed.
The College feels it is important that all guidance issued
in an emergency is produced with a summary document and that any
key information is highlighted, so as not to be missed by health
professionals. It is also essential that any guidance issued is
consistent with existing best practice. For this reason, the College
feels it would be of benefit for the Department of Health to work
closely with the College from the outset to produce paediatric
guidance in an emergency to ensure consistency with other evidence
based guidance and meets the College's standards for endorsement.
Dr Jan Dudley
Clinical Standards Committee Chair, RCPCH
With thanks to:
Brian Gennery, Joint RCPCH/NPPG Standing Committee on Medicines
member
Dr William van't Hoff, Joint RCPCH/NPPG Standing Committee
on Medicines Chair
Linda Haines, Head of Science and Research, RCPCH
Rita Ranmal, Clinical Standards Co-ordinator, RCPCH
Susan Mitchell, Head of Health Services, RCPCH
Royal College of Paediatrics and Child Health
14 September 2010
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