Adoption Process
The purpose of CTN adoption is to ensure excellence in study design, conduct, analysis and dissemination. Trial endorsement will provide the trial team access to the CTN infrastructure, most importantly the membership of active local and principal investigators. The CTN supports research projects involving the recruitment of patients where the aim is to improve outcomes following surgical treatment. This does not usually include research into surgical techniques except where there is clear overlap with perioperative medicine. Our focus is on large clinical trials but smaller studies may be appropriate for CTN support, especially if these are likely to translate into subsequent larger trials.
Requests for trial adoption will be made using a standard adoption form, and we aim to respond within one month with a preliminary decision. The CTN Director or deputy will identify two or more individuals to review each proposal, at least one of whom will be a member of the CTN Board. Assuming the proposed trial falls within the remit of the CTN, the over-riding factor determining adoption will be the quality of the trial proposal. The specific criteria are available here. The board will then consider the reviews and make a decision to adopt, to request the trial team address specific problems (revise and reconsider), to request a presentation of the proposal at a CTN meeting before further consideration, or to reject. Applicants may seek a review of the decision or re-submit a modified application after an agreed duration.
The following conditions apply for the duration of an adopted trial and all predefined sub-studies:
- All CTN studies must be presented to the CTN membership on at least one occasion prior to launch.
- The trial management group has the responsibility to obtain funding if not already secured and conduct the trial in accordance with CTN policies.
- All trials must be conducted to the highest professional standards, in compliance with codes of research conduct (Good Clinical Practice).
- The CTN must receive a written report once a year on the anniversary of adoption, or more frequently if requested.
The CTN Board reserves the right to withdraw endorsement at any stage if a trial fails to comply with CTN policies, if a trial is failing to progress adequately, or conflicts of interest are identified which make continued CTN support impractical or undesirable.
Both the full version and the outline of our New Study Proposal form can be found below:
POMCTN New Study Proposal Template Full v1.4 (2016).docx (85 KB)
POMCTN New Study Proposal Template Outline v1.4 (2016).docx (82 KB)
If you wish to enquire about the adoption criteria please contact us by clicking here. If you would like to submit an outline, please email: pomctn@niaa.org.uk
