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Practical examples of costing agreed
for research studies within LNR CLRN
10 November 2011
Elizabeth Kettle
LNR CLRN Senior Manager
Roz Sorrie
Lead RM&G Manager
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
Key principles
 All research activities that involve NHS resources
(premises, staff etc.) should not impact upon the
delivery of normal services to patients.
 Research activities should therefore be
understood and properly costed to ensure there is
no financial impact on this delivery
 There are three categories of costs to be
considered:
 Research Costs
 NHS Support Costs
 Treatment Costs
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
Research costs
 The costs of delivering the study itself. These
should be funded directly through the research
grant:
 Data collection/analysis.
 Salaries/indirect costs.
 Activities directly involved in answering the research
question.
 Sponsorship responsibilities - conduct, audit/monitoring,
pharmacovigilance.
 Registration of trials.
 Researcher training/conferences.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
NHS Support Costs
 Additional patient-related costs associated with the
research, which would end once the study in
question has stopped. CLRNs have a role to fund
all identifiable unmet service support costs, for
example:
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Extra patient tests.
Extra nursing attention.
Pharmacy support.
Participant recruitment.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
Treatment costs
 Treatment costs are the patient care costs which
would continue to be incurred if the patient care
service in question continued to be provided after
the study had stopped. These should be funded
through normal arrangements for commissioning
patient care:
 Costs of drugs.
 Excess Treatment costs – additional costs of
drug/treatment.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
How do I work out what’s what?
 Work through the protocol step by step keeping in
mind the classifications of cost
 Refer to the original grant application
 Seek out help, good places to go:
 NHS Trust R&D Offices
 CLRNs and Topic/Primary Care Research Networks
 University R&D Offices
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
Factors to be taken into account when
awarding SSCs
Grant
awarded
NHS R&D Form –
Overview of research
& activities
Protocol
SSI Form –
Procedures
Funding to Trust
Service
Support
Costs
CTA/
Any agreement?
CLRN infrastructure –
What’s been provided so far
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
Some examples.....
 Drawn from LNR CLRN experiences involving
different healthcare sectors.
 Successes – where things have worked smoothly.
 Challenges – where things appear to have stalled.
 Common themes - delays/blocks.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
ExACT: A randomised controlled trial of extended warfarin treatment versus routine
warfarin treatment for the prevention of recurrent venous thromboembolism and
post thrombotic syndrome in patients being treated for a first episode of unprovoked
VTE (CSP 47947)
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Extended warfarin therapy – 2 years as opposed to normal 6 month care
pathway.
One aim: Does extended treatment prevent recurrent clots?
One acute Trust/2 PCTs.
Anti-coagulation service locally – 2 models:
 Central provision from Acute Trust
 SLA for practice provision
Drug costs – warfarin calculated for experimental arm of study = £40.00 per
patient over 2 years = £1,120 for both PCTs.
Worked out in parallel to governance review.
One PCT led the costing work, but had joint discussion with the other – both
agreed to meet these.
Success factor: Costs identified and agreed in advance, with PCT Research
Leads fully engaged in the process.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
CALORIES - Clinical and cost-effectiveness of early parenteral compared with early
enteral nutritional support in critically ill patients. (CSP 22078)
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One acute Trust participating.
The primary objectives: to estimate the effect of early (defined as within 36
hours of the date/time of original critical care unit admission) nutritional support
via the parental route (PN) compared with the enteral route (EN) on mortality at
30 days.
To estimate the effect of incremental cost-effectiveness of early PN compared
with EN at one year.
PCT agreed to fund ETC of £250 per patient for up to 10 patients over 2 years.
This will be a maximum of £2,500.
Success factor: tenacity of Research Nurse in pursuing this matter with the
PCT.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
Prevention Of Decline in Cognition After Stroke Trial (PODCAST):
A factorial randomised controlled trial of intensity versus guideline lowering of
blood pressure and lipids. (CSP 18461)
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Led by acute sector (2 Trusts) with primary care involvement.
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The trial focusses on management strategy and the protocol does not stipulate specific
drugs, although it provides examples and relevant doses; however, local clinicians will use
locally supported interventions so long as they fit with the overall design of the trial, i.e.
intensive versus guideline BP and lipid lowering.
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Lead CLRN – Template available for service support costs for dispensing, phlebotomy,
blood tests.
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Department of Health Subvention in place: +£10K and above per year per PCT
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Drug costs are ETCs and PCT has agreed to their funding to a cap of 10 patients based
on subvention.
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Problem areas: misunderstanding of protocol, confusion over where/how costs incurred,
agreement on recruitment strategies by 2 acute Trusts.
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Success factors: Appropriate and pragmatic solution by PCT, DH subvention, clarity by
Chief Investigator.
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However, study still under governance review.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
A randomised controlled trial comparing the effectiveness of heparin bonded or
antibiotic impregnated central venous catheters with standard central venous
catheters for the prevention of hospital acquired blood stream infection in children
(CATCH). (CSP 39830)
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Aim: to compare which of 3 types of catheter (standard, heparin-coated, antibiotic-coated)
most effective in reducing infection in children.
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Adopted for delivery by an LRN.
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Acute Trust only uses standard central venous catheters (CVCs) – flagged up at a
meeting with Trust finance/commissioning months before governance review commenced.
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Trust initially willing to fund, but later wanted to refer to PCT, as in financial difficulty.
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CLRN then approached to fund the non-routine CVCs as service support, but not eligible
as a) consumables and b) excess treatment costs.
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LRN negotiated reduction in cost of CVCs and also eventually offered to fund additional
outstanding ETCs in order to commence study – with specific provisos.
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Success factors: Study ‘rescued’ by funding external to Trust/PCT.
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Problem areas: Setting precedents, avoiding due process, lengthy communications, time
taken.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
The SCOT Trial: The Standard care versus Celecoxib Outcome Trial.
A Large Streamlined Safety Study
 Aim: To compare cardiovascular and GI safety and effectiveness of
COX-2 inhibitor celecoxib versus traditional ‘usual care’ NSAIDs.
 Primary Care based study – participants over 60 with rheumatoid
arthritis or osteoarthritis.
 Requested by EMEA to add to scientific knowledge. Up to 50 patients
to be recruited.
 All drugs funded by Pfizer – during study and for six months after
participants have completed study. ETCs not an issue. Drug to come
off-patent in next year or so.
 PCT objections: contravenes prescribing policy, concerns over followon costs, impact on service direction.
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
LNR CLRN experience: delays/blocks
 Costs flagged up late (e.g. when governance review well
underway).
 Trust policy e.g. Study does not fit in with current
policy/strategy.
 Complexity of communications.
 Financial issues e.g. deficits where all decision making is
deflected back to the PCT for final decision irrespective of
PbR Tariff.
 Others?
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
Discussion/Questions?
 Understanding the various costs of studies can be
difficult, then trying to ensure the different parties
involved are aware of and will fund the various
costs is another challenge!
 What role can we play:
 As R&D Professionals?
 As Researchers?
 As Commissioners?
 As Provider Trusts?
 As other advocates/supporters of research?
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network
Any Other Questions?
Leicestershire, Northamptonshire and Rutland Comprehensive Local Research Network