How is the adoption decision made and what is the benefit?
An Industry Trials Adoption Panel will be convened by the NIHR and currently meet by teleconference on an ad hoc basis. They will review the Industry Trials Submission Form, capability and protocol feasibility reviews and if necessary the protocol. Adoption of industry trials into the network portfolio will be reviewed on the following criteria:
Is there a genuine and testable hypothesis with a possible future benefit for patients as its objective?
Is there a statistically valid trial design which is reasonable for the stated main objective and main hypothesis of the trial?
Have the trial and its design been subjected to an adequate peer review process?
Does the DeNDRoN 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?
The benefit to study adoption is a guarantee that additional nurse or trial officer resource is available to support recruitment at investigator sites. We can also help to support less experienced investigators, ensuring that all study procedures conform to research governance guidelines. All staff working on adopted trials will also be able to access NIHR training, ensuring that all site staff have a competent and documented understanding of ICH GCP and the EU Clinical Trials Directive. DeNDRoN also has a responsibility to performance manage enrolment, increase overall recruitment capacity and nationally promote trials adopted by the network.