We estimated the average recruitment period in reports of multicentre randomised controlled trials (RCTs) funded by the National Health and Medical Research Council (NHMRC) in the New England Journal of Medicine between January 2001 and December 2011. The terms ‘trial’ and ‘Australia’ were entered into the New England Journal of Medicine Advance Search facility on its website (http://www.nejm.com), yielding 177 articles, from which 20 RCTs that were fully or co‐funded by NHMRC were identified. The mean recruitment period for all 20 RCTs was 4 years 11 months (range 1 year 9 months to 9 years 10 months). However, the mean recruitment period was 18 months longer for the 11 RCTs with primary neonatal or paediatric outcomes than for the other nine adult trials (Table 1). These recruitment periods do not include the time needed for follow‐up.
Table 1. Reports of NHMRC‐funded multicentre randomised controlled trials in N Engl J Med, 2001–2011
To see all Trials: https://onlinelibrary.wiley.com/doi/full/10.1111/jpc.12061
All these trials are likely to have significant impact on clinical practice, because they were reported in the world's most highly cited medical journal. They illustrate the need to invest considerable resources and time, often well beyond 5 years, to address important study questions, rather than curtailing recruitment, diminishing power and scientific validity.
What strategies might accelerate recruitment? Several trials in the table employed international collaboration to achieve samples of hundreds or thousands. Another strategy to accelerate recruitment, not yet widely employed in Australian trials nor exemplified in the Table, is to establish fully funded networks of local research coordinators, in sites with adequate volumes of patients.1
Government‐funded clinical networks, which include local site research nurses or coordinators to support clinical trials, have already been established to improve the co‐ordination, speed and quality of randomised controlled cancer trials in Australia2, 3 and of paediatric and neonatal trials in the United Kingdom.4 Similar investment merits consideration in other specialties in Australia, particularly in perinatal, neonatal and paediatric clinical trials, where life expectancy in survivors spans several decades.
A third strategy is to engage consumers and parents as full partners in all aspects of the design, conduct and implementation of trials. This may enhance their relevance to patients and accelerate recruitment and the implementation of their results.4