When you apply to collaborate with the East Kent Clinical Trials Unit, we will assess your application using the following criteria:
Need for the research
Clear demonstration from the evidence base (including a formal review of relevant Randomised Controlled Trials) that the research is needed.
Importance of the research question
The trial must address a question that is clinically important (such as areas of crucial evidence gaps, or areas of controversy or high variation in clinical care).
Relevance
Must be relevant to the population – particular interest in trials of global importance.
Feasibility
To ensure trials progress in line with expectations, in particular recruitment and retainment of participants, the research team will be assessed for an appropriate blend of experience and clinical credibility.
The assumptions behind the study will be critically reviewed, with evidence sought upfront that these assumptions are reasonable.
If no such reassurance is possible, then it will be sought from a pilot study or early returns as the study commences.
Methodologically sound
The optimal scientific design, with the best and most appropriate analysis, with suitable methods of managing and conducting the trial will be required, along with trial registration and a full commitment to publish the results in peer reviewed journals.
Financially viable
EKCTU involvement in a study must be appropriately financed. Staffing and consumable costs will be reviewed to ensure the trial is adequately funded and deliverable in the proposed timelines.
Fits in with the aims of our CTU
Trial should enhance and confirm EKCTU reputation for excellence in delivering high quality, clinically relevant, methodologically sound Randomised Controlled Trials.
Ethically sound
The risks and benefits have been considered, awareness that there is a need for high ethical standards in research.
Quality assured
Although some trials may be successful on all of the above criteria, if the EKCTU does not have capacity to take on the responsibilities, it will not be adopted.
