NCRN and Industry

The NIHR CRN CC is tasked with developing a world-class infrastructure to ensure that high-quality research funded by both commercial and non-commercial organisations receives the support it needs to succeed.

Such support will include investment in the expansion of dedicated clinical research staff within the NHS, and the development of standard procedures to ensure consistent best practice at network study sites through both study set up and conduct.

The NIHR CRN CC  has established a dedicated Industry team to address the specific challenges and pressures faced by the healthcare industry in successfully delivering their research and development projects through the NHS. The NIHR CRN CC  Industry team is working closely with the healthcare industries, the Department of Health, and NHS Trusts in identifying barriers to the delivery of clinical research in the UK, and formulating solutions and strategies to overcome these.

The following leaflet gives a brief introduction to these themes:

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

Dr Matthew Cooper – Principal Fellow – Clinical Trials

Miss Julie Kitcheman – Industry Portfolio Administrator

The Industry team can be contacted at  industry@ncrn.org.uk

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