Improving equity of access to cancer clinical trials in Scotland

Appendix 4: Detailed Recommendations of the Finance Work Package

Rigorous, transparent, and consistent study costing

Issues

a - Issues with consistency and completeness in costings.

Notes

• Sites can take inconsistent positions on study activity
• Not all items included
• Issues with amendments, setup, follow-ups
• Current cost model is expected to capture all trial costs.
• Models are agreed at UK level
• Consistency is a key part of ongoing development of the Scottish system

Recommendations and actions

• Review current arrangements for capturing and recording trials costs vs standard of care and address any variability in approach.
• Develop standard costing models for non-commercial studies
• Review processes for robust and rigorous costing of amendments
• Review standard rates for setup and follow-ups, then forward for UK wide agreement
• Consistent use of EDGE or equivalent

Issues

b - Split site models may not be reflected in current costing models

Notes

Details of the operation of split sites are still being developed

Recommendations and actions

Review models for capturing different costs at different site types; develop new models as needed

Issues

c - Lack of awareness within NHS of clinical and indirect benefits of research

Notes

• NHS Clinical trials can deliver significant benefits beyond direct financial returns.
• These include drug savings due to provision of drugs from study sponsors
• Other benefits to service, both direct and indirect, include staff development and better patient outcomes.

Recommendations and actions

• Develop standard approaches which can be implemented Scotland-wide to capture drug savings.
• Consult with the research community to identify associated non-financial benefits, and ways to quantify and capture that information
• Provide information on drug cost savings and other benefits to service to relevant NHS executive staff.
• Consider development of simple organisational KPIs, to support wider awareness of research deliverables. These could include:
  • Number of studies
  • Complexity or study type
  • Number of patients consented and recruited
  • Gross value/savings to service

Operation of standard funding model

Issues

a - Loss of commercial income due to fewer studies delivering during pandemic

Notes

• Early indications are that commercial activity is recovering.
• Loss of income offset by vaccine trials, but benefit was limited to specific departments, and impact will be greater on smaller Boards

Recommendations and actions

• Process development is ongoing at UK/Scottish level issue
• Issues can be raised as part of discussions with industry at the CSO Industry Partnership Forum (IPF).

Issues

b - Impact of suspended studies and extended timelines in non-commercial studies

Notes

Delays impacted timelines and staff funding flows

Recommendations and actions

• Consult network leads to identify and articulate issues, processes and improvements required
• Engage with UK managed Recovery programme to support delivery and income

Issues

c - Impact of pandemic on charitable funding

Notes

Ability to affect this is limited, but pragmatic approaches can be considered

Recommendations and actions

Consult network leads to assess extent of issues and identify ways any improvements required

Issues

d - Reliance of cancer research centres on charitable funding

Notes

• Cancer research activity is supported by a variety of charitable sources of varying sizes and operational remits.
• Key posts required for delivery are often dependent on raising funds through charitable sources.
• Access to these funds is often restricted to groups or regions.

Recommendations and actions

• Explore options for Scotland wide collaboration to support coordinated and efficient use of charitable resources.
• Identify areas where reliance on charitable funding may affect resilience and continuity of research service.

Issues

e - Not all activity is captured within a per patient funding model

Notes

Standard funding model is based on patient contact and income. Different study models and increased stratification may impact this model.

Recommendations and actions

Consult with stakeholders on longer term impact and possible solutions to feed into future discussions on network and trial core funding models.

Issues

f - Patients do not routinely have access to trials for clinical services which rely on Out of Scotland Service Provision

Notes

• Current arrangements do not provide a standardized model for funding excess treatment costs for clinical trials
• National services are planned without including a plan to provide equitable access to cancer trials

Recommendations and actions

• Review these arrangements for CAR-T cell therapy and Proton Beam therapy, and ensure there is a consistent approach which can be applied to other highly specialist trials
• Ensure that planning processes for national cancer services address equitable access to clinical trials from the outset. This should be a standard field in service applications and scoring criteria

Internal disbursement and use of funds

Issues

a - Drugs cost avoidance & EAMS

Notes

• Cost of drugs provided by sponsors, particularly commercial, is not routinely available, or considered. There is scope to engage with NHS management in identifying of opportunities for savings and reinvestment
• EAMS offers opportunities for managed transitions from trials to practice

Recommendations and actions

• Review current activity, and agree Scotland-wide models, to routinely collect data on drug avoidance costs. (See also item [2] above)
• Explore opportunities around EAMS. Engage with management teams on those decisions where there could be a financial benefit to service.

Issues

b - Board to Board transfers

Notes

• Models are dependent on development of flexible working models, driven by MHRA recommendations.
• Service level agreements are preferred model, but are not standardised
• Split site models require transfer of funds between sites, but this may not be well understood, and there is no standard model.

Recommendations and actions

• Review use of inter-board financial SLAs for access to cancer trials
• Review process for Board-to-Board transfer of funds for split site studies, and agree standard templates or guidance if necessary

Issues

c - Internal disbursements

Notes

• Effective use of funds is vital for developing integrated research and clinical models. By capturing savings and using income systematically Boards can build capacity in equitable ways. The impact of this will be magnified in smaller Boards, which may receive less central funding.
• Models vary widely across Scotland.
• Systems allowing patient and activity tracking, notably EDGE, have proved extremely useful for financial tracking
• Limitations in the use of income across budget years limits the ability to use income effectively to develop capacity.
• NIHR have produced guidance

Recommendations and actions

• Facilitate mechanisms to enable local reinvestment of trial income, savings and core funding to feed into service design allowing joined up service and trial management activity.
• Engage with Board finance departments, to note existing NIHR guidance, and seek high level agreement to share information on models
• Research network managers should be provided with transparent information on income within their remit and have a role in managing use of funds.
• Review wider accounting issues with planning across financial years to clarify obstacles and identify potential solutions.
• Support wider use of applicable electronic tracking systems. This would allow:
  • Closer links between trial activity and finance
  • Better identification of benefits of trial activity
  • Improved split site invoicing and disbursement

Funding for regional and split-level studies

Issues

a - Contracting and SLAs

Notes

Issues noted above in 3(b)

Recommendations and actions

N/A

Issues

b - Regional Boards access to commercial studies

Notes

There are several barriers to placement of studies at smaller Boards: cost of setup for additional sites, larger geographic spread, and lack of specialist services.

Recommendations and actions

• Gather evidence on placement of commercial studies
• Further develop the existing "One Scotland" model to leverage opportunities in reducing the cost of additional site setup
• Review Central Feasibility data to identify bottlenecks and resource limitations

Issues

c - Regional access to specialist services may affect study placement

Notes

Key examples include radiotherapy

Recommendations and actions

• Gather evidence of lack of placement of studies in regional sites, and any reasons
• Explore options to develop split site models, and address lack of regional specialist services.