How can DeNDRoN support industry trials?

DeNDRoN offers two levels of service to support start up of an industry trial:

1) Initial FEASIBILITY Review

If the sponsor needs to obtain sufficient top-line information to commit to UK participation and patient numbers, DeNDRoN can help facilitate this.

Once a confidentiality agreement has been signed off with UKCRN, DeNDRoN will conduct a Feasibility assessment on the sponsor’s behalf, commenting on issues within the Clinical Study Outline (CSO)/ draft protocol which may impact upon recruitment, including reviewing the number of patients that could expect to be recruited within the specified timeframe. This can be worked down to the number of patients an average site would be able to recruit, although there is no commitment at this stage for investigators to participate in the study.

 The CSO is sent out to each Local Research Network (LRN) manager to obtain information from their pool of experienced investigators; the information is then fed back to the DeNDRoN co-ordinating centre. In parallel the CSO is sent to the Clinical Study Group chair or delegate, to provide a top level review of any protocol issues that may impact upon recruitment e.g./ use of placebo, disallowed medication, drug naivety etc.

We therefore guarantee to be able to gain the input of at least three experienced investigators to comment upon feasibility of your clinical study outline/protocol.

This information from both sources is then collated and provided to the sponsor. We appreciate that this request is usually at short notice, so we aim to provide a feasibility report back to you within two weeks, following sign off of the UKCRN confidentiality agreement.

 The benefit to gaining DeNDRoN input at this early stage is to identify any major protocol issues that could be addressed before release of the final protocol and raise the awareness of the forthcoming trial to UK investigators.

At no point during this process has any commitment been made to adopt or support the trial within any of the LRNs.  

 2) Full FEASIBILITY & CAPABILITY review for adoption

Once the sponsor has confirmed that the study will run in the UK and a final draft protocol is available, the sponsor should contact Clare Morgan to discuss requirements and expectations of study adoption. A UKCRN confidentiality agreement must be signed off before any confidential documents can be forwarded to DeNDRoN; therefore we strongly recommend finalising a generic agreement with UKCRN at the earliest opportunity.

The full feasibility & capability review process is ideally performed before MREC application or at least in parallel, so that we can identify investigators (if required) and capture information for you to complete COREC Site Specific Assessments (SSAs). The study will then be adopted or rejected from the study portfolio based on this comprehensive information.

In order for the Industry Trials Adoption Panel to consider a study for adoption, a copy of the study protocol must be submitted to the DeNDRoN Coordinating Centre via UKCRN. This may be a final draft protocol or current final protocol, however full review will not be carried out on clinical study outlines/protocol synopses.

In addition, the UKCRN Industry Trials Submission form should be completed; much of the information requested on this form is routinely provided on the COREC and CTA application forms.

UKCRN Industry Trials Submission Form (word document, 130 kb, opens in new window)