Transcript Attributing the costs of health Research & Development

Attributing the costs of health
Research & Development –
AcoRD
Elizabeth Coote
Head of Non-Commercial Research Services
TASC
[email protected]
NRS – delivering research excellence
Session will cover ….
• reasons for change
• implementation of AcoRD
• basic principles behind the guidance
• process for attribution
• examples of costs
•Q&A
NRS – delivering research excellence
Reasons for change
• attribution practice hasn’t always reflected
guidance
• change in overall funding landscape
• improving the consistency of cost
attribution and research funding
• encourage researchers to consider the
total cost of the research they plan
NRS – delivering research excellence
Implementation
Implementation
• applies to grant applications submitted after 1
October 2012
• Agreed by working group of AMRC, CSO, DH
• Does NOT apply to Commercially Sponsored
research i.e. all costs are research costs
NRS – delivering research excellence
Principles
Principles of AcoRD (1)
• No changes of definitions from ARCO
Research costs
– relate to activities required to answer research
question
– end when research ends
– met by funder through grant
• AMRC exceptions
NRS – delivering research excellence
Principles of AcoRD (2)
NHS Treatment costs
– patient care costs
(prevention/diagnosis/drug/therapy)
– would continue even after research finished
– met by NHS from general budget
– if disproportionately expensive, subvention
(Excess Treatment Costs (ETCs)) can be
applied for
NRS – delivering research excellence
Principles of AcoRD (3)
NHS Support costs
– additional patient care costs associated with
research
– end when research ends, even if patient care
service would continue
– met from NRS allocation to Boards OR
through support from Scottish Networks
NRS – delivering research excellence
Guidance documents
3 sections
• main Guidance that covers the background,
principles and attribution process
• annex A provides an Exemplar lists of
activities and where they should be attributed
• annex B provides a set of Frequently Asked
Questions (FAQs)
– FAQs are updated periodically
NRS – delivering research excellence
Annex A
Exemplars split into 3 sections – research,
support and treatment costs
Research costs fall into 2 categories
• Part A costs met by all grant funders
• Part B costs met by grant funders except
where the funder is a member of the
AMRC, where HBs expected to pick up
cost
NRS – delivering research excellence
AcoRD Attribution
process
Attribution principles
• Attribution driven by Primary Purpose, so
“why?” not “who?” or “where?”
• SSC must be a patient care service
“ a service provided by, or on behalf of, the NHS where that
service treats, or contributes to, the care needs of a patient”
• if an activity does not contribute to patient
care then it is a Research cost
NRS – delivering research excellence
AcoRD section 3.12
Where the primary purpose of an activity is
to generate data to answer the research
question, then the activity is not primarily
concerned with patient care and is regarded
as a Research Cost, even where it is a
clinical activity
NRS – delivering research excellence
Attribution Step 1
• identify activities being carried out with
primary purpose of answering research
question (by definition these will end when
the research ends)
• these are RESEARCH COSTS
• examples of Research Costs are listed in
Annex A
NRS – delivering research excellence
Attribution Step 2
• activities that are NOT research costs, i.e.
patient care costs, must be split between
treatment and NHS support costs
TREATMENT COST
– activity integral to provision of clinical
service/care, whether standard or
experimental
– would be incurred if treatment/service was
provided out with the context of research
NRS – delivering research excellence
Treatment costs
• for attribution purposes you should assume that
an experimental intervention/service being
tested will continue after the end of the study
• most interventions that are being tested or
compared as part of a study will be treatment
costs (even if they are experimental, unlicensed for the
condition or not approved and even if there are no plans
to continue with the intervention after the study has
ended)
• Placebo/sham treatments are NOT treatment
costs
NRS – delivering research excellence
Attribution cont
NHS SUPPORT COST
– patient care activity which would not occur if
treatment/service was being provided out with
the context of research
– activity driven by the NHS duty of care to a
patient (e.g. to ensure safety of research
participant) OR
– patient care activity primarily undertaken to
facilitate research
NRS – delivering research excellence
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’
Yes
No
The activity is a Research
Cost because it is not
directly contributing to
patient care
The activity is a patient care
cost.
Is the activity integral to the
provision of a treatment (or
diagnostic) regime?
Yes
The activity is a
Treatment Cost
If funder is an
AMRC member
No
The activity is a Service
Support Cost
Attribute costs
between Part A
and Part B
Research costs Part B
• Non-AMRC funders must meet the costs of Part A
and B activities
• If funder is an AMRC member, and activities can
be undertaken by existing staff, PART B costs will
be met through NRS funding
– Networks, NRS infrastructure, NRS researcher
support
• where activity is of a level that cannot be
accommodated by existing staff then it must
be met by funder
NRS – delivering research excellence
Research costs Part B
• local study coordination/management
• data collection to answer research question
(includes completion of CRF)
• regulatory preparation and compliance
• time taken by CI/PI to explain study to colleagues
NRS – delivering research excellence
Costing NHS staff time in
applications
• Based on activity not person
• What is the purpose of what they are doing?
•
•
•
•
Administering treatment
Ensuring safety
Will it continue?
Answering research question?
• Can this be done by existing staff?
• May be split in time depending on activities
– Attribute, estimate and request from funder if
necessary
NRS – delivering research excellence
Examples
For example (1) ……
• Intervention Study involved 3 blood samples
from participant: 1 sample for bio bank; 1 sample
routine clinical care and 1 sample to assess
baseline biochemistry
Current - Funded through support costs
• AcoRD – Sample 1 = research cost
Sample 2 = treatment cost
Sample 3 = support cost
NRS – delivering research excellence
For example (2) ……
Current
• A randomised placebo controlled CTIMP
– Randomisation is research cost
– Pharmacy costs assigned as support costs
AcoRD
– All Placebo costs are research costs
– Pharmacy set up/close down is research cost
– IMP dispense is treatment cost
– Individual IMP accountability is support cost
NRS – delivering research excellence
Specific issues
Invitation to participate
Q How is contacting an individual to invite
them to participate attributed?
A This is a research cost as the primary
purpose (recruitment) is in relation to
answering the research question
– comes under Part A so should be requested
from the funder
NRS – delivering research excellence
Costs of repackaging
• Q. I know that the cost of dispensing the intervention
medicine for a study is a NHS Treatment Cost, but
the drug has to be repackaged locally at each
recruitment site specifically for the trial. Is the
repackaging a NHS Treatment Cost even though it
would not need to repackage the drug once the
study ended even if we continued to dispense the
drug to patients?
• A. The repackaging of an intervention drug is a
research activity where it is performed centrally either by
a single NHS organisation or by a non-NHS supplier for
use by all recruitment centres. However, where a NHS
organisation repackages a drug locally for its own use,
the activity is a NHS Support activity.
NRS – delivering research excellence
New diagnostic tests
Q I intend to analyse pathological samples with the
long term aim of introducing a new diagnostic
process – how should I attribute the costs?
A Analysis of samples to see if they are able to
inform diagnosis is too far downstream to be
considered a treatment and therefore is a
research cost. If there is then a further study (or
second phase) where you e.g. compare whether
the (same) analysis is better than standard
diagnosis then at this point the activity would be
considered a treatment cost.
NRS – delivering research excellence
Imaging
Q As part of my study scans will be carried out after
every cycle of chemotherapy to look for drug
efficacy
A As the primary purpose of the scan is to
determine efficacy, the scans should be classified
as research. Even if the scan also looks at
potential toxicity and/or is put on the patient
record, this does not over-ride the primary
purpose
NRS – delivering research excellence
Staff time
Q As part of my intervention study a nurse will
consent the patient, administer a QoL
questionnaire and take patient BP – how are
these costs attributed.
A Consent – NHS support
Questionnaire – Research
BP – depends why it’s being done – if it is a
research data item then it’s Research (Part B), if
it is a study of a BP lowering drug then Research
(Part A), or if it is to check intervention doesn’t
affect BP then NHS support
NRS – delivering research excellence
Hints and tips
Tips
• researchers should seek to minimise costs by
efficient study design, not by omission
• researchers should seek appropriate advice in
good time before grant submission
– support from all available sources (funder, R&D
office, CTU, network etc OR CSO)
• Individuals involved in attribution/costing need to
understand the detail of the study
– relevant information included in application form
NRS – delivering research excellence
Potential problems
• Not referring back to the definitions of the 3 types
of costs
• Not considering primary purpose of activity
• Assuming because an activity takes place in the
NHS it must be a NHS cost – not true
• Assuming that funding for NHS costs works in the
same way as funding for research costs
NRS – delivering research excellence
Boards/networks have limited
resources and may not be able to
support your study appropriately if the
cost attribution has been inaccurate
NRS – delivering research excellence
Any questions?
[email protected]