Study Adoption Criteria
Studies must accord with the CTN Terms of Reference and all other relevant CTN policies. Study protocols submitted for consideration to the CTN must be developed in accordance with the best practice guidelines of research conduct (GCP) and include sufficient treatment of the following areas in the application.
Background
Hypothesis, rationale, referenced review of the topic and study aims summarising the state of the research area and setting the principal research question in context. Evidence for clinical uncertainty regarding the health care intervention studied.
Research Plan
A detailed research plan including an explanation of research methodology (randomised trial, observational cohort etc.). Adequate explanation, in plain language of the intervention being studied and a description of comparator group(s). Justification of the choice of primary outcome and details of any secondary outcomes to be included.
Statistical Review
Strong, credible statistical foundation to the study design including estimated intervention, effects based on previous research, published trials or systematic review/meta-analysis. Sample size calculations, based on estimates of adequate power to detect a “Minimum Important Difference” for primary outcome.
Feasibility
Evidence of a credible case for research completion, including realistic estimates of potential eligible participant numbers, capacity projection at proposed study centres, sufficient equipoise amongst clinicians a demonstration that consent is possible.
Funding
Grant secured, proposed study budget or a consideration of potential funding streams to which application will be made, depending on the stage of project development.
Ethics
A review of relevant ethical issues and details of ethical approval if already attained
Study management
Nominated management committee and sponsoring institution, details of the Clinical Trials Unit providing support to study conduct. This CTU should hold UK national registration if a clinical trial is proposed. Details of Trial Steering Committee and Data Monitoring Committee, if required.
Research Design
Evidence that applicants have consulted a Research Design Service or received equivalent support in project development and obtained suitable critical analysis of their research proposal.
Patient and Public Involvement
Approval will be dependent on the provision of strong evidence that patients or their representatives have been involved in the generation of the research proposal from inception to application.
Health Economics
If health economic analysis is to be carried out alongside a clinical study, details of the evaluation from an NHS perspective should be included.
Investigators
The chief investigator(s) must fulfil the criteria detailed in the CTN CI scheme. Proposals for the appointment of site specific principal investigators should be included.
Dissemination
Proposals for the mechanism of dissemination of study findings, including publication, presentation at national meetings, engagement with key “Gatekeeper” health professionals to enact policy change and pathways to make research findings accessible to the public.
Relationship between CTN Endorsement and Grant Applications
Investigators must not indicate in a grant application that the study is endorsed by the CTN until formal endorsement has been provided in writing by the CTN Executive.
