How can industry engage with NIHR CRN CC ? PDF file, 1.2 MB

The NCRN Industry team are working in close collaboration with the NIHR CRN CC  and the Pharmaceutical Industry to bring commercial oncology studies into the national NIHR Portfolio.

Professor Rick Kaplan – Associate Director

Ms Jenny Gray – Industry Lead

Miss Julie Kitcheman – Industry Portfolio Administrator

The Industry team can be contacted at  This e-mail address is being protected from spam bots, you need JavaScript enabled to view it  

Further detailed information on the NIHR CRN CC  Working with Industry process can be found at the main NIHR CRN CC Industry page http://www.ukcrn.org.uk/index/industry.html.

Industry Trials Feasibility and Adoption Process
As for all other research taken on by the networks, industry-contract studies must be formally adopted by the NIHR CRN CC . The NIHR CRN CC  industry team has developed a process specifically for the adoption of industry-contract studies which has been informed by discussions with industry through the UKCRC Industry Road Map Group. The process takes into account the needs of industry, in particular, the time constraints faced by companies. Therefore, the Industry Trials Adoption Process is a highly streamlined process in order to meet the tight timelines often required by industry.

Level 1 Feasibility – top line national feedback from individuals
We aim to deliver a decision about the suitability of study to be conducted in the UK within 2 weeks. This rapid assessment considers if the UK has the appropriate subject population for a study and whether the treatment plans differs fundamentally from standard UK treatment pathway(s).

Level 2 Feasibility – detailed site level feedback including adoption onto the UKCRN Portfolio.
If Level 1 Feasibility has not previously been conducted, it will be performed at the beginning of this process, to rapidly access the suitability of the study to be conducted in the UK.

Following this, an in-depth feasibility including adoption onto the NIHR CRN CC  Portfolio will be performed. This will provide information about potential sites/investigators; assess anticipated patient numbers and the availability of research resources including skills, facilities and equipment. We aim to complete this process within 4 weeks.

The UKCRN Costing Template
 

The NIHR CRN CC Costing Template has been developed on behalf of the National Institute for Health Research (NIHR) and addresses a specific recommendation made in the Cooksey Report, which highlighted the need for a transparent and consistent national costing system for commercial research.

The NIHR CRN CC Costing Template has been implemented to speed up the initiation of industry contract trials by reducing the time required for site-by-site negotiations. It is based on the principles articulated in the NHS Finance Manual and is intended to provide transparency, greater consistency and predictability on costing for companies.

This version has been developed for use in contract trials of pharmaceutical and biotechnology agents in secondary care. Templates suitable for use in primary care studies and in studies of medical devices are being developed. This Template is not suitable for use in costing non-commercial/academic trials however this need is being addressed by NIHR CRN CC.

The NIHR CRN CC Costing Template will be used for all relevant studies intended for adoption by the NIHR Clinical Research Networks (England). Although developed primarily to support these studies, the methodology is freely available to companies interested in running trials outside the Networks. NIHR CRN CC is working with the devolved nations to facilitate development of comparable systems for implementation across the UK.

The Template has been developed and piloted in a collaborative process involving the NHS and industry stakeholders. It will be reviewed and updated, as required, in the light of broader experience.

For further information please visit the main NIHR CRN CC Industry page http://www.ukcrn.org.uk/index/industry/costing.html

• Click here to download the UKCRN Costing Template (Version 1.2) XLS file, 450.5 KB

• Costing Industry Sponsored Studies through the NIHR Networks: Supporting information and guidance PDF file, 232.3 KB