Clinical Trial Costing Guidance
This document has been developed by the UK PD-CSG and the NCVR PD Document Development Working Group to assist the life sciences industry and lead study sites with costing commercially sponsored Parkinson’s Disease (PD) clinical trials within the NHS.
This document has been developed by the UK PD-CSG and the NCVR PD Document Development Working Group to assist the life sciences industry and lead study sites with costing commercially sponsored Parkinson’s Disease (PD) clinical trials within the NHS.
UK PD-CSG NCVR Guidance Document v1 26.01.2024.pdfIt is intended to be used as a guidance document to assist with completion of the NIHR interactive Costing Tool (iCT) and should be read alongside the associated NIHR costing guidance, NIHR iCT Tariff Costs and relevant study documents. It will support the UK lead site (where the CI is based) and Industry sponsors to consider all costs and accurately capture the true resources required during the national contract value review (NCVR), to reduce protracted negotiations being required at each site when the budget is shared with other participating sites.
It is intended to be used as a guidance document to assist with completion of the NIHR interactive Costing Tool (iCT) and should be read alongside the associated NIHR costing guidance, NIHR iCT Tariff Costs and relevant study documents. It will support the UK lead site (where the CI is based) and Industry sponsors to consider all costs and accurately capture the true resources required during the national contract value review (NCVR), to reduce protracted negotiations being required at each site when the budget is shared with other participating sites.
The NIHR iCT provides a framework to enable transparency and consistency of costs and to support NHS sites in budget negotiations with commercial sponsors. The NIHR iCT tariff costs are simply a guide and provide suggested timings to aid the completion of the iCT. These suggested timings and costs within the iCT tariff are generic and cannot consider the variability in different therapy areas. PD clinical studies are often complex and due to patients’ varying levels of disability, the time taken to complete even straight-forward procedures can take considerably longer than in healthy participants. This guidance document is intended to support costings by providing procedure times that are specific to PD. Trials involving atypical Parkinsonism should consider the likely variability in some activity length, such as examination visits, due to the complexity of the patient population.
The NIHR iCT provides a framework to enable transparency and consistency of costs and to support NHS sites in budget negotiations with commercial sponsors. The NIHR iCT tariff costs are simply a guide and provide suggested timings to aid the completion of the iCT. These suggested timings and costs within the iCT tariff are generic and cannot consider the variability in different therapy areas. PD clinical studies are often complex and due to patients’ varying levels of disability, the time taken to complete even straight-forward procedures can take considerably longer than in healthy participants. This guidance document is intended to support costings by providing procedure times that are specific to PD. Trials involving atypical Parkinsonism should consider the likely variability in some activity length, such as examination visits, due to the complexity of the patient population.
We would welcome feedback about the content and usage of this document.
We would welcome feedback about the content and usage of this document.