The aim of this guidance is to facilitate more efficient trial delivery, and in particular reduce delays in trial set up associated with agreeing the attribution of costs for Response Evaluation Criteria In Solid Tumors (RECIST) reporting.
Please note that this guidance applies to new grant applications and is not intended to be applied retrospectively to studies that have already been funded.
Background
RECIST is a set of rules that define when tumours have responded, or progressed following treatment. It requires accurate and consistent tumour measurement and is a protocol requirement in many oncology trials, particularly those testing novel drugs. It was introduced in 2000 as a much simpler replacement for the previous WHO Response Criteria. The original criteria were modified in 2009 (RECIST 1.1), and again in 2014 (irRECIST) for use during immunotherapy. There are a number of less common protocols in use (Cheson, irRC, PERCIST, Choi, RANO) and occasionally a trial will have a specific variant.
In recent years there have been difficulties at many cancer centres accessing RECIST reporting for clinical trials. This has in some cases prevented or restricted patient access to novel therapies. One of the reasons for this is a lack of clarity about the correct cost attribution - is RECIST reporting a research cost (to be included in the research grant), a service support cost (to be covered by the LCRN), or should it be considered standard of care? This confusion has led to delays in trial set up and difficulties in collecting data once the study is open.
In consultation with major funders, clinical trials units, sponsors and Trust R&D departments we have agreed that since RECIST reporting is a research tool, designed to assist the evaluation of novel therapies, it should be considered a research cost and included in research grants.
Cost implications
Currently both the NIHR Industry Costing Template (ICT) and the equivalent non-commercial template the Schedule of Events and Cost Attribution Tool (SOECAT) details the cost of RECIST reporting as £111 per scan. This is because the costs detailed within the SOECAT have been directly transferred from the ICT without removing the commercial overheads.
When these commercial overheads are removed the cost of a RECIST report is around £65 per scan in line with the costs reported by Trusts.
It is important to note that whereas the costs in the ICT are fixed, within the SOECAT the costs detailed are intended to be a guideline. The SOECAT’s main purpose is to attribute costs correctly (i.e. whether the cost of an activity is a treatment cost, research cost or a service support cost) rather than assigning a cost to the activity itself. However the costs detailed in the SOECAT are considered by most of the research community as fixed and mandatory which is resulting in significant cost implications for non-commercial studies.
Conclusions
Following on from discussions with the teams responsible for the SOECAT, it has been agreed that RECIST reporting is a research cost and if required in a study should be included in grant applications at a recommended level of £65 per scan.
We acknowledge that the number of scans requiring RECIST reporting varies between studies but based on data we currently hold we recommend an average number of three scans per patient. Therefore an average of £195 per patient is a reasonable amount to be costed into grant applications. Investigators are encouraged to consider at what time points RECIST reporting is actually required to avoid unnecessary costs.
The assignment of costs associated with activities listed in the SOECAT is currently under review with the aim of clarifying costs for non-commercial studies so we are likely to see significant changes in the information provided in the SOECAT over the coming months.