Nottingham Clinical Trials Unit
Criteria for engagement
The Nottingham Clinical Trials Unit (NCTU) aims to conduct clinically important high quality
randomised trials that improve health and wellbeing. Clinicians and researchers wishing to engage
with NCTU are advised to contact us early in their planning.
The success and value of NCTU depends on the quality and relevance of the trials conducted. The
selection of new trials at NCTU is based on the following criteria:

Addresses an important question
The proposed trial must address a clinically important question. For example, if the trial is
successful, there is a reasonable expectation that the results would lead to a worthwhile change
in clinical practice or public health policy.

Identified gap in our knowledge
An appropriate high quality systematic review supports the need for a trial.

Feasibility
There should be a well thought through strategy for demonstrating that it is feasible to recruit
and retain participants into the trial. The assumptions behind the study projections should be
supported by evidence that they are realistic. If this evidence is not available, it should be sought
from a pilot study or early returns as the study commences. The study should be led by a Chief
Investigator with the correct blend of experience and clinical credibility.

Methodologically sound
NCTU engages with leads of individual trials at the planning stage to ensure the optimal
scientific design, with the best and most appropriate analysis and suitable methods of managing
and conducting the trial.

Appropriate research team
Project team has an appropriate skill mix, and there is clear agreement about the role of NCTU.

Potential to secure funding
There should be identified potential sources of funding. For example, based on identified
priorities for the NHS, a topical issue, or a commissioned or themed call.

Financially viable
NCTUs involvement in the study must be appropriately financed, with a minimum expectation
that NCTU recovers the true cost of its engagement in the study.

Attractive to NCTU
NCTU will assess its engagement in a trial based on the expectation that the trial should
enhance NCTU’s reputation for delivering high quality, clinically relevant and methodologically
excellent or innovative trials. Factors that will be considered include:
o Would the trial results contribute to significant change in the clinical management of a
condition
o Does it add coherence to the NCTU portfolio, does it fit within our existing themes
o Would the proposal enhance the strategic plan of the School of Medicine, for
example is it in a clinical area recognised to be a local strength
o Are there opportunities to explore methodological advances in the design and
conduct of clinical trials