How is the 'adoption' decision made and what is the benefit?
Introdution:
Introdution:
An Industry Trials Adoption Panel will be convened by the
UKCRN 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 UKCRN 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.
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