How are collaborations between UKCRN and industry established?

In order to benefit from the support of the networks’ infrastructure, studies must first be adopted into the UKCRN Clinical Research Portfolio. The purpose of adoption is to ensure that UKCRN resources are committed to supporting well designed, high priority research studies, which address the strategic needs of the NHS and its patients.

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 UKCRN. The UKCRN 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 UKCRN 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 has appointed an Industry Trials Adoption Committee which provides a ‘pool’ of clinical trialists with expertise covering the Comprehensive Clinical research Network and each of the Topic Specific Clinical Research Networks.

The criteria on which panel will make adoption decisions for industry-contract trials are as follows:

1. Is there a genuine and testable hypothesis with a possible future benefit for patients as its objective?
2. Is there a statistically valid trial design which is reasonable for the stated main objective and main hypothesis of the trial?
3. Have the trial and its design been subjected to an adequate peer review process?
4. Does the UKCRN network infrastructure have the current capacity to deliver the trial data reliably and on time?
   a. Are there conflicting studies within the current Portfolio?
   b. Are there sufficient patient numbers?
   c. Is there sufficient investigator interest?

For industry-contract studies adopted by networks, there is also the added proviso that such research is supported by the network on a full cost recovery basis in order to protect the allocation of network resources in supporting studies funded by charity and public sector organisations.

How to submit an industry-contract study for adoption by UKCRN

In order for the Industry Trials Adoption Panel to consider a study for adoption, a copy of the study protocol must be submitted to UKCRN or the relevant Topic Specific Clinical Research Network Coordinating Centre. This may not necessarily be the final version of the protocol, but must be the most recent version. In addition, a short Adoption Process and Feasibility Assessment submission form should be completed.

There are no deadlines for the UKCRN Industry Trials Adoption Process and studies may therefore be submitted for adoption at any time. Industry Trials Adoption Panels will meet by teleconference on an ad hoc basis with the aim of returning a decision on adoption and study feasibility within 6 weeks. In the interim, documents may be submitted via email. Please contact the UKCRN Industry team on industry@ukcrn.org.uk to arrange submission.

What about confidentiality?

It is recognised that much of the information submitted by companies to UKCRN will be of a confidential nature. However, in order to return a prompt decision on adoption, the UKCRN must be in a position to share and discuss details of proposed studies with members of its Industry Trials Adoption Committee.

The UKCRN Industry team has again worked closely with industry through the UKCRC Industry Road Map Group to develop an arrangement underpinned by a set of generic confidentiality agreements which will facilitate discussions between the company and the UKCRN, and the UKCRN and the members of its Adoption Committee. These agreements need be signed only once to cover any future discussion between the UKCRN and healthcare companies wishing to submit studies for adoption. Please note that the use of these generic agreements is not mandatory but is encouraged in order to minimise any delays in the discussion of industry-contract studies with the UKCRN.

Please contact the UKCRN Industry team on industry@ukcrn.org.uk to obtain copies.