Supporting and applying research in the NHS. 1. Overview

Transcription

1 Supporting and applying research in the NHS 1. Overview

2 Improving commercial research set-up Recap of ongoing activities NHS England and the National Institute for Health Research (NIHR) have published a joint statement committing to 12 actions to support and apply research in the NHS. A public consultation on proposals including how to eliminate delays and further improve commercial clinical research set-up and reporting (action 2) followed and now this document provides further outline for the initial principles and how these will develop into operational processes. A dedicated webpage will be used to provide the latest updates around the actions being undertaken to reduce delays during study set-up and to speed up access for patients.

3 Improving healthcare for patients The benefits of eliminating costing and contracting delays Making the NHS in England a more attractive base for research would serve to benefit patients, NHS providers and the wider UK economy. Working towards a simple commercial contract research costing review process: Enables mutual assurance across NHS providers to cost-effectively set-up commercial contract research Enable earlier site open dates by minimising the time spent negotiating costs and contracts at individual sites Balances fairness and competitiveness to improve local access to studies for patients across the country Reducing trial start-up times is cost-effective for all involved and builds the reputation of the NHS to attract more research from commercial companies globally

4 October is just the start Building on existing approaches The Industry Costing Template has been in use and refined annually for 10 years and works alongside the Model Clinical Trial Agreement, first released 5 years earlier. October 1st marks the requirement for NHS providers to utilise both the cost methodology and contract terms for commercial contract research*, enabled through NHS England s Standard Contract changes. As all providers will be using the same approach at that point, further efficiency can be introduced in a review once and share approach and instilling confidence in mutual assurance. Commercial contract research* in this context is defined as a research project that is fully sponsored and fully funded by a commercial company, regardless of NIHR CRN portfolio status and EXCLUDES Investigator-Initiated Trials (defined as studies sponsored by a non-commercial entity e.g. University or NHS, with some level of funding being provided by a commercial organisation) and other industry collaborative studies or protocol development activities not sponsored by a commercial entity.

5 Reaffirming the existing approaches The existing NIHR Industry Costing Template and review processes already support full cost recovery Methodology endorsed through specific guidance from HSG(97)32 policy Study specific price charged = Time based calculation using hourly rates derived from top of band NHS AfC/ M&D salaries with employer National Insurance/ Pension contributions + Defined % for indirect infrastructure running cost element defined in the NHS Costing Manual as overheads (e.g. lighting) or indirect costs (e.g. security). + Defined % for income generation above the study specific activity cost intended to reinvest in the research offering from the provider + NHS Improvement National tariff Market Forces Factor value to reflect location-base cost differences for each provider Per patient activities Direct costs Indirect costs Capacity Building Market Forces Factor Set-up, management and close-down activities Annual Updates Reflect latest financial year values: - National tariff elements - Hourly rates - Prescription charges - NHS inflator/deflator value for set price lists All updates approved by the multi-stakeholder Governance Group each March Feedback and Oversight Multi stakeholder Governance group oversee and approve revisions Department of Health and Social Care (DHSC), NIHR, Health Research Authority (HRA), Devolved Administration Research Networks, NHS Providers, Commercial Companies including Commercial Contract Organisations, National Pharmacy CLinical Trials Advisor Group (NPCTAG), UK Clinical Research Facilities Network Feedback submission form on NIHR website reviewed by Governance Group twice a year User support Toolkit of resources to: Understand and populate study specific requirements Justify appropriate adjustments to guidance content (price and timings) Integrate agreed prices into site level model clinical trial agreement financial appendix

6 Reaffirming the existing approaches The existing ABPI model clinical trial agreement already defines pre-agreed study contract terms between commercial companies and NHS providers Updates Initial template introduced in 2003 Suite of templates expanded to cover primary care, tripartite for Contract Research Organisations Anti-bribery act updates in 2011 Recent update to terms released 2018 Pending update for General Data Protection Regulation (GDPR) Feedback and Oversight HRA facilitated feedback from NHS Providers ABPI facilitated feedback from commercial companies Governance group with defined escalation process in development to support ongoing template refinement Suite of agreements ABHI to further develop the model Clinical Investigation Agreement (mcia) Ongoing work to create non-interventional agreement

7 Further needs of the research community For a single review process to work... Independent point of escalation for adherence and exception management Unmodified model agreement use including defined financial appendix format AND a digital, online costing template to manage multi-party workflow, access and generate consistent outputs Single process for all commercial contract studies with single point of access Mutual acceptance achieved through evidence that builds confidence in the process, standards and methodology Respected and empowered community of National Coordinators across providers, care settings and therapy areas to work directly with commercial companies Operates alongside assessing, arrangement and confirming local capacity and capability activities and information provision to link practical delivery with costing methodology and contracting terms

8 Supporting and applying research in the NHS 2. Progress to date

9 Specialists location methodology review To ensure the existing template can be utilised across specialist research locations, template adaptations have been defined. Template content for specialist locations This will include: Defined Clinical Research Facility list Clarity on infrastructure funding for clear facility use charge rules Focus on charges for overnight stays/out of hours and intensive clinical activities or patient monitoring This will include: Defined Experimental Cancer Medicine Centre list Clarity of coverage for operational activities (non-patient facing) and outsourced investigations Input to investigation list review through further workshop held on 5th July

10 Revised investigation list content To ensure the existing template can be utilised across all NHS providers, a broader list of research investigations has been collated Previous exercises to revise content have had limited impact prior to intention to embed the costing template methodology for all NHS providers. The methodology review ahead of implementation has: Cross checked against commercial budget tool provider lists to identify gaps Aligned with NHS National Tariff where possible Identified organisations an experts with standardised processes for determining reflective prices Investigation price list review - creation of experts by experience to inform fair market value

11 Initial principles for a single cost review Sponsor generates study requirements using NIHR Industry Costing Template Support provided by Lead Site/Network as required to understand costing template and process National Coordinator for the study is assigned from lead or participating locations, triggered by final protocol provision as part of NIHR portfolio application (via CPMS) Coordinator assigned Coordinator links with all relevant clinical, support service and care setting expertise to ensure appropriate resource for all patient and non-patient activities required for study delivery are specified Requirements reviewed Coordinator provides single point of contact with company to determine core budget required for the study on behalf of all sites Study resource negotiation Core study budget made site specific by applying standard methodology including identification of defined variations or exemptions for site type/ involvement Site specific versions created Sites permitted to include amends to investigation prices to align with local service level agreements as part of financial appendix format Pre-defined adjustments in contract Individual contracts executed with each site Any feedback on methodology issues shared with costing template governance group Coordinator Assignment Dedicated NHS Provider based resource in a lead or participating site for the study From a community of practice pool across the healthcare setting of pre-identified experts in research costing Assignment criteria using expertise profiles to select nation coordinator location per study during feasibility Flexible timing for assignment during early study planning with defined latest point for assignment, aligned with expectations for Sponsors to provide all necessary information for accurate review Expectations Work to the highest quality existing standards for determining resource required Defined mechanism to refine collated standards across research community Accredited costing and contract review training to be delivered with the R&D forum including industry input Grow and sustain experts without restrictions on number or location of National Coordinators No expectation to have experts at each site Can transfer role to another as necessary Coordinator Role Recognised and respected role within research community to negotiate to the highest level of activity capture on behalf of all sites Required to access to clinical and support department expertise including specialist location considerations as relevant Two way approach with commercial company to determine resource requirements to deliver the study (seperate to site specific capacity and capability) Responsible for generating a statement of assurance to outline costing discussions providing visibility for participating sites Assigned for study duration to include amendment cost review

12 National standards to ensure consistency Existing best practice has been collated to determine study requirements with commercial company and ensure clinical and service input Collated from existing job descriptions and good practice costing approaches shared to date, national standards will be built on to ensure a National Coordinator undertaking a cost review: Applies their commercial clinical research experience in the best interest of patients Provides an effective, high quality, timely and efficient financial service increasing the attractiveness of the NHS for research placement Considered a core component of effective study set-up to provide prompt and clean study data Has in-depth understanding and is an ambassador for the costing template methodology Communicates NHS costing approach effectively to negotiate full cost recovery providing flexibility to grow research offering Focuses on identification and sufficiency of study requirements and the associated timings Proactively seeks out relevant clinical and service support expertise to determine appropriate resource requirements Considers operational requirements for study delivery such as Sponsor communication expectations Access to study information, such as the Full Protocol or Clinical Investigational Plan, Laboratory Manual, Radiology Manual, Pharmacy Manual, e-crf and training needs Escalates areas of significant cost variation from cost methodology for resolution Facilitates communication/collaboration with all study sites and Sponsor Works to mutually agreed timelines Supports general research income distribution principles Clarifies NHS methodology alignment with Full Economic Costs for Higher Education Institution research sites Has authority to act in national capacity endorsed by R&D leadership Shares best practice across the NHS and builds peer support with other National Coordinators Recognise bespoke approaches for novel trials/designs and utilises to inform future standards Innovates and responds to change to make the best use of collective NHS resources Coordinating clinical expertise alongside service support input defines study resource requirements

13 Review once and share for efficiency Nationwide pool of existing local resource will be national coordinators This approach: Formally endorses NHS Provider staff to act in nationwide capacity with defined accountability linked to NHS Provider standard contract Balances on the ground knowledge while working with national operating procedures Gives visibility to the national coordinators across the country Builds peer-to-peer support to underpin a common understanding, interpretation and application for commercial research costing Ensures there is nationwide consistency in way of working, negotiations and costs agreed to ensure confidence in the process Defines overall study resource requirements separate to assessment of individual site capacity and capability based on these

14 Escalations and Refinements Identifying areas for continual improvement to optimise both methodology and process consistency Costing Review/ Expert Reviewer Identification Stage Testing Stage Implementation and Post Implementation Stage Now Leading into and after 1 Oct 18 From 1 Oct 18 and into 2019/20 Refining standards Further sharing of existing practices and standards to refine reviewer profile including clinical expertise Identify any further areas of inconsistency Current site set-up fees will be utilised locally for ongoing skills development and process refinement for the nation-wide process Consider lessons learned from service level costing approach (communications and methodology) Audit against standards Use of multiple expert reviewers during testing phase to audit level of subjectivity in applying standards Comparison to retrospective resource requirement variation levels Time and motion benchmarking Monitoring impact of simplified arrangements: - Global competitiveness - Participating sites - Real time study timelines - Impact of site cost variations Study Escalation Dedicated single point of escalation to utilise with defined response timelines Central log of escalated issues (process and methodology) supporting root cause analysis to address underlying issue. Include capture of non costing/contract related issues exposed as process embeds Continuous improvement through formal six-monthly governance group informed by collated escalations and areas of price variance Independent Change Manager oversight

15 Supporting and applying research in the NHS 3. Defining the detail

16 Who has been involved so far? Multi-stakeholder advisors involvement ensures sector wide input to shape the approach Costing and sustainability working group Programme Management Office UK R&D Leaders Group Strategy and Leadership Group Managers Working Group Clinical Research Expert Network (CREN) Coordinating Centre Local CRN and partner organisations, specifically those with region-wide costing approaches

17 What next? Determine content of national guidance as referenced in the 1 Oct NHS provider standard contract change Identify existing costing expertise to build self national coordinator community Share outputs on the NIHR webpage including: Roadmap of planned activities Developments in process and operational information Revised investigation price list for Industry Costing Template Provide opportunities for input from research community Maintain open communication with devolved administrations Focused effort on ensuring the appropriate resource for each study can be is efficiently identified to provide the data needed to improve patient pathways