These findings also support the recommendation in the Good Participatory Practice guidelines that prior to trial implementation, research teams need to develop plans for early termination of trials in consultation with relevant stakeholders [27].
This difference seemed to be associated with REC comments on clauses in clinical trial agreements for industry-sponsored trials, in particular regarding the publication of results and premature termination of trials.
To overcome this challenge and to avoid early termination of the trial and an underpowered trial, a time extension was judged necessary.
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.
Large differences in the primary outcome measure between groups in a clinical trial may lead to early termination of a trial (following recommendations of a data safety and monitoring committee) [ 49].
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].
During the 10-year post-interventional period, differences in blood pressure between the two groups during the trial disappeared within 2 years after termination of the trial and the benefits of previously improved blood pressure control were not sustained when between-group differences in blood pressure were lost [ 38].
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.
A patient will be withdrawn from the trial if the trial participant withdraws his consent and will, in connection therewith, be informed that termination of the trial will have no implications for his future treatment.
Sequential boundaries approach, the TT and DTT, permit repeated statistical analyses to be performed throughout the trial recruitment period in order to allow for early termination of a trial while maintaining a pre-specified α and β level.
