understanding research service support costs and excess treatment costs
DESCRIPTION
Understanding Research Service Support Costs and Excess Treatment Costs by Reshma Raycoba, NISCHR AHSC R&D Costing Manager. 20th May 2014 at Bangor University at the NISCHR CRC Research in Practice: Sustainability, Quality & Improvement event for International Clinical Trials Day.TRANSCRIPT
Understanding Research Service Support Costs and Excess Treatment
CostsReshma Raycoba
NISCHR AHSC R&D Costing Manager
20th May 2014
Scope
• The content of this discussion covers non commercial portfolio research studies ONLY
• Discusses Wales-specific arrangements• For commercial research, ALL additional elements
above standard care are covered by reimbursement from the commercial sponsor
• For non commercial non portfolio studies, alternative sources of funding or support must be identified
Definitions
• For all NHS non commercial portfolio research studies, the AcoRD policy applies (from October 2012)http://www.wales.nhs.uk/sites3/page.cfm?orgid=952&pid=62653
• AcoRD is a UK wide policy, with country specific documents in place to reflect local arrangements
AcoRD Outline
• Policy framework that facilitates the attribution of activities into the correct category in order to identify the source of funding to cover that activity
• It is important to ensure that the Primary Purpose of the activity is clear
• Must assume that the intervention being tested will be adopted as standard care for the purpose of accurate attribution
• Budgets in question:• Grant funder budget (e.g. Research charity, NISCHR
RfPPB, MRC, etc)• Usual NHS Commissioning Budgets• NHS Research-specific budgets from NISCHR, Welsh
Government:– NHS Support Cost Budgets – Primary Care, Public Health and
Emergency Care (centralised in Wales); Secondary Care (included in NHS R&D Organisations’ Allocations from NISCHR, WG annually)
– NHS Research Staff – e.g. NISCHR CRC Research Nurses, research staff funded through NHS R&D allocations
– NHS Excess Treatment Cost Budget (centralised in Wales)
Definitions cont...
• Research cost activity– An activity that is only happening in order to
answer the research question – No direct impact on patient care
• Examples: – Randomisation; – Collecting data and filling in Case Report Forms for a study; – Holding focus groups to ask participants about their
experience of being in the research project
Definitions cont...
• NHS Support Cost Activity– An activity that is only happening for the
duration of the research project that impacts on patient care, but would not continue to be provided if the intervention being tested became standard care – usually safety related
• Examples: – Informed consent (agreed attribution with funders); – Searching the NHS patient record (e.g. Database searches); – Additional blood tests to check patients’ safety only for
the duration of the study (results fed back to the patient’s clinical care team)
Definitions cont...
• NHS Treatment Cost Activity– An activity that is an integral part of the
intervention being tested, which would be what the patient experiences if you assume that this intervention will be adopted as standard care
• Examples: – Administration of study drug (NOT placebo – placebos are
always covered by research costs)– Provision of interventions, e.g. Cognitive Behaviour
Therapy sessions
• Ideally, attribution of these activities should be done by the Chief Investigator when applying for a grant from a funder that is a portfolio eligible partner
• Funders will scrutinise the attribution, particularly for NIHR and NISCHR funded studies – more funders coming on board with the pilot of the Activity Capture and Attribution Template (ACAT)
• This means that each site can quickly identify the resources required to deliver the study at set up stage
• This is the ambition and your R&D Office will be able to advise on this as part of the permissions process – contact them at the earliest opportunity
Attribution Flow Chart
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In the context of this study, is the activity a ‘service provided by, or on behalf of, the NHS where that service treats or contributes to the care needs of a
patient’?STEP 1
This is a patient care cost activity
This is a research cost activity
Will the activity still be required if the
intervention being tested becomes standard care?
Is the funder a NIHR partner
AMRC member?
This is a treatment
cost activity
This is a NHS support cost
activity
Attribute research activities between Part A and Part B
STEP 2Yes No
Yes No
Yes
ATTRIBUTION EXAMPLES
• Example 1 (Examples based on real studies):Participants will be randomised to take a course of IMP, or a matched placebo, for one week.
Q: How would you attribute the following:• Randomisation• The cost of the steroid• The cost of the placebo
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• Example 2:After written informed consent is given, the following assessments must be performed:
• Complete medical history check against inclusion/exclusion criteria• Report on concomitant medications
After completion of the baseline procedures, the patient will be randomised.
Q: How would you attribute the following:• Informed consent• The check against inclusion / exclusion criteria
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• Example 3:This study aims to contact smokers over the age of 18 who have attempted to stop smoking twice in the last 2 years but have not been successful.
• 40 GP surgeries will be approached and asked to conduct mail outs to send the study details to those patients on their list that might fit the criteria.
Q: How would you attribute the following:• The Practice Manager’s time taken to conduct the database search• The stationery and postage costs and time taken to stuff envelopes and
do mail merges etc
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ACCESSING RESEARCH COSTS, SUPPORT COSTS AND TREATMENT COSTS
Research Costs
Central Research Costs e.g. Salary costs for
research team
Site Level Research Costs e.g. To cover NHS clinical time collecting
data etc
Submission to Grant Funder as
part of application
Application Successful –
Grant awarded
Funding provided to
Sponsor (funding schedule
provided as part of the
contract process)
Sponsor pays Central
Research Costs either
to NHS organisation or University
Sponsor pays each site for the Research Cost Activities undertaken, as agreed at the study set
up stage *
* Note that for some charities that invest in the NHS research infrastructure, some research costs will be covered by the NHS R&D budgets – see AcoRD for further details
NHS Support Costs & Resources
NISCHR, WG
NHS R&D Allocations
Research Support & Governance Funding,
Support Cost FundingResearcher Support & Portfolio
Development Funding
NHS R&D Office assesses each study to identify level of support required
Based on activity from the previous year
Secondary Care Support Cost Resources
NISCHR, WG
NISCHR CRC Research Delivery Teams
May be able to provide some staff support as identified by
R&D office at study set up stage
Where appropriate and possible, staff support provided for NHS Support Cost Activities e.g. Taking informed consent
NISCHR, WG
Centralised SSC Budget for Primary Care, Public Health and
Emergency Care Portfolio research studies
Study team to apply directly to NISCHR, WG for SSC activities
apart from those being covered by NISCHR CRC team
NISCHR, WG authorises request and invoice raised by study
teamSupporting
servicesStaff
support*
Primary & Secondary Care Delivery Resources
Centralised Support Cost Resources
NHS Treatment Costs
NHS Treatment
Cost activities identified for study
Compare to
Current Standard
CareTreatment cost activity versus
current standard care
If intervention is over current standard care, Excess Treatment Cost
If intervention is less than current standard
care, Cost Saving to the NHS
If intervention is the same as current
standard care, cost neutral
Study team and sites submit
applications to NISCHR, WG
(with R&D sign off for
Secondary Care studies)
Centralised Excess
Treatment Cost Budget
for Wales
Application approved by NISCHR, WG and invoicing arrangements
agreed
Usual NHS Commissioning Arrangements
Cost saving to be recorded
and reported in order to give a
balanced perspective on the impact of NHS research
AcoRD
Research Costs
Research Part A
Research Part B (AMRC studies)
Treatment Costs
Over and above standard care =
Excess Treatment Costs
Less than standard care = Cost Savings
Support Costs
Direct NISCHR Funding
Primary Care / Public Health Support Cost
Budget (NISCHR) or NISCHR CRC staff resource
Centralised Excess
Treatment Cost Budget
(NISCHR)
Secondary Care R&D Allocations or NISCHR CRC staff resource
Other external sources of funding
R&D Allocations from NISCHR,
Welsh Government or NISCHR CRC staff
resource
Research Grant Income (Lead site)
Research Grant Income (host site)
AcoRD and how costs are met
Centralised NISCHR budgets
Support Available
• Attribution can be complex, but there is a lot of support available:– NHS R&D Office– Costing expertise in local teams– NISCHR AHSC R&D Costing Manager– Escalation route to NISCHR if particularly
complex