Patients and control participants will follow the same study plan unless stated otherwise; an initial screening visit will be followed by an intervention period of 12 weeks and a follow-up visit in the week after termination of trial medication.
Given the need to locate up to two targets and to make an explicit search termination response, trials were removed from analysis if the first or second RT was greater than 7000 msec or if the total RT for the trial was less than 200 or greater than 20,000 msec in length.
However, by definition, we cannot rule out an effect of underpowering and related beta error on the outcome measures (including renal outcome measures) after early trial termination.
We compared the Bayesian fractional additivity model to a conventional analysis by measuring the expected proportion of failures, sample size at trial termination, time to termination, and root mean squared error of final estimates.
Additional considerations include the potential for competing trials in the UK (for example HER2 therapies in advanced disease) and particularly the delivery of accrual to trials and where trials fail to achieve recruitment targets, termination of the trial.
To overcome this challenge and to avoid early termination of the trial and an underpowered trial, a time extension was judged necessary.
We expect a 25% drop-out of patients between inclusion and the follow-up meeting 26 weeks later, due to premature termination of the trial participation, inability to cooperate in the trial, or mortality[ 11].
Reasons that may necessitate a termination of the trial include a potential health hazard caused by the trial treatment indicated by incidence or severity of SAEs in this trial, unsatisfactory patients' enrolment, severely inaccurate and/or incomplete data recording or external evidence demanding a termination of the trial.
After termination of the trial, a retrospective explorative analysis was performed to determine whether the trial might have been able to reach statistical significance regarding the primary end point if continued as planned.
Only 28% (9/32) papers referred to early trial termination in the Title or Abstract, and 41% (13/32) addressed the implications of early termination in the Discussion section.
