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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: 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) 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) 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) Led by acute sector (2 Trusts) with primary care involvement. 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. Lead CLRN – Template available for service support costs for dispensing, phlebotomy, blood tests. Department of Health Subvention in place: +£10K and above per year per PCT Drug costs are ETCs and PCT has agreed to their funding to a cap of 10 patients based on subvention. Problem areas: misunderstanding of protocol, confusion over where/how costs incurred, agreement on recruitment strategies by 2 acute Trusts. Success factors: Appropriate and pragmatic solution by PCT, DH subvention, clarity by Chief Investigator. 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) Aim: to compare which of 3 types of catheter (standard, heparin-coated, antibiotic-coated) most effective in reducing infection in children. Adopted for delivery by an LRN. Acute Trust only uses standard central venous catheters (CVCs) – flagged up at a meeting with Trust finance/commissioning months before governance review commenced. Trust initially willing to fund, but later wanted to refer to PCT, as in financial difficulty. CLRN then approached to fund the non-routine CVCs as service support, but not eligible as a) consumables and b) excess treatment costs. LRN negotiated reduction in cost of CVCs and also eventually offered to fund additional outstanding ETCs in order to commence study – with specific provisos. Success factors: Study ‘rescued’ by funding external to Trust/PCT. 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