How to reduce the risk of failing to reach recruitment targets: Lessons learnt from a pump pilot trial

摘要

Large-scale multi-centre randomized controlled trials (RCTs) are regarded as the gold standard in rigorous, robust clinical research. Rates of participant recruitment, however, are often challenging and can have major impact on the planning, execution and funding of trials. Failure to recruit sufficient numbers of participants, or extended delays in recruitment, can threaten the trial's success and resources, in terms of both time and money. Trials frequently fail to recruit to target. In 2007, Campbell and colleagues reported that more than 80% of all trials fall short of their accrual goals, potentially seriously compromising the validity of the findings [1]. UK publicly funded (Medical Research Council and Health Technology Assessment) trials are no more successful. Between 1 January 1994 and 31 December 2002, only 35/114 (31%) of trials recruited successfully (i.e. equal to or above original recruitment target).