Trials Portfolio

The current processes for including studies in the NCRN Portfolio are described below. From January 2004, only new studies can be considered for inclusion in the NCRN Portfolio. This means that on-going studies (i.e. those that are open to recruitment) cannot be retrospectively incorporated into the Portfolio.

1. Process for including nationwide studies

Nationwide studies are those that are open to national centres across the country. All nationwide studies will be considered by CTAAC, whether or not funding is required.

a. New nationwide studies requiring funding

New nationwide studies requiring funding should be submitted to CTAAC as an outline application. Studies submitted to CTAAC should first be considered by the relevant NCRI Clinical Studies Group. Short-listed applications will then require a full application. This will involve independent peer review and consideration by the relevant NCRI Clinical Studies Group, if not already carried out.

For details of the closing dates and application process for CTAAC see http://science.cancerresearchuk.org/fandm/grantapplications/cta/?version=6.

In addition, studies commissioned and funded by other members of the NCRI (for example, National R&D Programmes) will also become part of the NCRN Portfolio.

b. New nationwide studies that have not opened to recruitment but have funding from a non-NCRI organisation and/or do not require additional funding

New nationwide studies that have not opened to recruitment but have funding from a non-NCRI organisation and/or do not require additional funding should be submitted to CTAAC as a full application. Studies submitted to CTAAC should first be considered by the relevant NCRI Clinical Studies Group. The review by CTAAC will involve independent peer review and consideration by the relevant NCRI Clinical Studies Group, if not already carried out. This process includes the inclusion of international trials (e.g. EORTC trials) in the NCRN Portfolio.

For details of the closing dates and application process for CTAAC see http://science.cancerresearchuk.org/fandm/grantapplications/cta/?version=6.

2. Process for including local/non-nationwide studies

Local/non-nationwide studies are those that are not open to national centres across the country and which are taking place in one or two centres within a Research Network or across one or two Research Networks. These studies are important for the NCRN to develop a research portfolio which includes all research of good quality that falls within the NCRN remit and which will eventually contribute to the phase III portfolio.

The advantage to Research Networks, individuals and Academic Units of incorporating their work is that they will then have the opportunity to make use of NCRN resources. For example, where NCRN research data collection staff are working in a clinical area to collect data for the phase III trials within the nationwide portfolio, it seems sensible, efficient and good practice for them to be collecting data for the more local portfolio in the same clinical area. This will also allow planning for the maximum efficiency of the use of NCRN resources, alongside other academic resources and staff.

The term ‘approval’ will now be used for the inclusion of local/non-nationwide studies, in line with the CTAAC approval of nationwide studies.

The inclusion of local/non-nationwide studies has not been straightforward to date, and the process has been modified to ensure that studies are approved more quickly, whilst maintaining the high standards required.

Studies must have been subjected to full and proper independent peer review prior to submission for NCRN approval. All studies should have a clear and detailed protocol. Studies submitted without a sufficiently detailed protocol will not be considered for NCRN approval. Investigators are strongly advised to involve a statistician in the design of the study and the protocol development.

Applicants must have agreement from the Clinical Lead for Research in their Research Network that the study can be submitted for NCRN approval for inclusion in the Network’s local portfolio. This is to ensure that the Research Network is notified of the study and is involved in the submission and the decision as to whether it fits within the local NCRN portfolio. The Clinical Lead for Research will also be able to discuss how the study will benefit from being in the NCRN portfolio and how NCRN resources will be used.

The closing date for the next call for applications for local/non-nationwide studies is 7th April 2006. Only new studies should be submitted for approval.

Application Form

Guidance

For further information contact Rachel Moser, Tel: 0113 392 4479.