ICR Ethics & GCP Forum – Part 5 of 5
Bringing the conference to a close, Laura Bousfield of the NIHR Clinical Research Network spoke about the new template to be used for costing clinical research within the NHS, some improvements that were made to the template in October 2012, and a new review process that was announced earlier this year.
The template is a set of spreadsheet files covering IMP/non-IMP studies and medical device studies, both in primary and secondary care settings. These tie in with the standard model agreements, which have been agreed at a top level by the Department of Health, the ABPI and BioIndustry Association. The templates provide a consistent framework and standardised methodology for cost calculations, making cost negotiations more transparent. These prices cannot be mandatory, but are advised. Laura explained that industry benefits from the transparency of the templates as a starting point for negotiations, while the NHS ensures that all costs are properly reimbursed.
The templates are broken down into set-up, per-patient and additional costs based on task time and standardised hourly rate. There is also a 70% overhead to cover indirect costs such as heating, electricity and other facilities, along with a 20% capacity-building element which is expected to be re-invested into delivering clinical research. There is also a location-based adjustment, again based on standard NHS rates.
After this overview, Laura went on to explain the changes to the templates published in 2012.
The first of the changes was the addition of a definitive list of fees relating to study set-up. This retained the R&D management fee, but also added specific fees for department set-up, site initiation (including all study-specific training), Chief Investigator fee, fee for substantial amendments. Other fees were listed as “cost of doing business” and explicitly not chargeable, such as finance, HR etc. New charges were added to cover patient identification activities.
Pharmacy fees have long been a controversial area in negotiations, so Laura’s group worked to simplify the structure of charges. For example, the IMP management fee is made clear as being a fee per year per site. The overall fee has been reduced, but individual items (eg, document revisions, use of IVRS, waste disposal etc.) are now separate line items rather than being part of a single annual fee. Another layer of fees are set out per drug and/or per patient visit.
Another addition Laura discussed was an invoicing function. This pulls data from the final completed template with breakdowns. Dates are entered for the invoice period, and multiple invoices can be generated and stored along with an historical record and summary sheet.
Laura highlighted that these templates are a joint tool, and are continually being reviewed and updated as appropriate, and she welcomed feedback on use of the costing tool.
Finally, Laura spoke about a project to align cost review with NHS permission, because a signed contract is required before NHS permission can be granted. After taking 8 months to review the project and tools, the system went live earlier this year and specifies how roles and activities around costing and permission are correctly divided between network-wide and local site administrators. At the point of R&D submission, the network will conduct a study-wide check, reviewing the costing against the schedule of events and reviewing the contract against the model agreement. When individual sites are notified that they could be participating in the study, the local sites will review the costing and contract. Laura stated that the full process should take place within 30 days. She encouraged delegates to visit the NIHR CRN website (www.supportmystudy.nihr.ac.uk) for further details on this.