Whether it’s the nurse’s salary, which is often dependent on the income of commercially sponsored trials, or the costing of research proposals for grant applications, the economics of research have increasingly become a feature in the role of the research nurse. We need to understand the costs associated with undertaking studies so that all resource use is cost-effective.
In years gone by, commercial companies would offer a per-participant fee for each trial, and the research nurse would look at all the procedures involved in the study and either agree the fee or try to negotiate with the sponsor company to increase it if he/she thought it necessary. As there was no robust process for calculating a per-participant fee, the economic viability of a study was entirely dependent on the experience of the research nurse. In diabetes research units where the salary of any research nurse is dependent on commercial income, this can mean the difference between having a job or not! When the National Institute for Health Research (NIHR) set up the Clinical Research Networks, one of the working groups involving research staff and pharmaceutical representatives developed the NIHR Industry Costing Template. This has subsequently been revised a couple of times, and the current versions, now available for both primary and secondary care, were published in April 2014 (NIHR, 2014).
The costing template gives approximate timings for all procedures that could be involved in a clinical trial, with space to add in the cost of more complex tests (for example, meal tolerance tests and magnetic resonance imaging scans). The research nurse can simply populate the template with the procedures performed at each visit and, using a standard pay rate for doctors, nurses and administration staff, the template calculates a per-participant fee for the study. Hence, a much more consistent per-participant fee can be charged for studies. Often, the template will be completed by the sponsoring pharmaceutical company, but the research nurse can still negotiate with the sponsor if he/she feels that the timings, and thus costings, are not as they should be. These costing templates have been a huge step forward in ensuring that studies and nurse workloads are appropriately remunerated and that NHS resources are not used to subsidise commercial clinical research.
Research nurses working on academic studies are often asked to help with the costings involved in the study whilst the grant application is being written. As the cost of the research nurse to conduct study procedures is usually the largest single cost in a grant application, it is critical that this is calculated correctly. There is no costing template for academic studies, but the research nurse can adapt the industry costing template to gain an approximate per-participant fee that can be used in the grant application.
There are many other costs involved in conducting clinical research within the NHS; for instance, all blood tests have a cost (although these can vary between different Health Boards and Trusts), as do the supplies required for taking a blood sample, for example, butterfly stitches, cotton wool balls, plasters and blood sampling bottles. If the study requires hundreds, or even thousands, of blood samples, all these costs must be factored in so that NHS stocks are not subsidising the research. Sometimes the cost of blood tests can be reimbursed to the individual Health Board/Trust from the Government health departments via Service Support/Support for Science costs, but this must be checked with the local Board/Trust before the grant application is made.
Because we all work within the NHS, which is free at the point of care, it can seem like an alien concept for research nurses to attach a cost to all the procedures they perform, but for clinical research to flourish we need to learn how to cost studies – either academic or commercial – so that resources are used in a correct and efficient manner.
Su Down looks back on a year of change and achievement.
17 Dec 2024