A randomized controlled trial (RCT) to improve enrollment to cancer clinical trials

Background: The proportion of adults with cancer recruited to clinical trials is low. Cancer Council Victoria awards funding to clinical trial sites through its Clinical Trials Management Scheme (CTMS). With this state‐wide scheme, there appeared to be a temporal relationship between growth or stability in funding and the number of patients recruited. We undertook a RCT to evaluate the hypothesis that additional funding would improve trial recruitment. Methods: Participating sites (n = 34) were stratified into four strata based on 2011 recruitment numbers. Control sites (n = 18) received usual CTMS funds only while intervention sites (n = 16) received usual funds plus additional funds, proportional to the number of patients recruited in 2011. Additional funding was a median increase of 300% (IQR: 112.5%, 459%) relative to usual CTMS funds and was an average 11.8% (IQR: 8%, 12.3%) increase in a site's budget. Additional funds were provided in early 2013. Sites were to use funds with the aim of increasing recruitment. The primary study endpoint was the number of new participants recruited to clinical trials in 2013 relative to recruitment in 2012. Negative binomial regression analysis was used to model the endpoint in intention‐to‐treat analysis adjusting for any imbalance in randomized groups' features and historical recruitment. An online survey was used to assess strategies employed to increase recruitment. Results: The median number of new trial recruits in 2013 was 21 (IQR: 5, 39) in the control arm and 12.5 (IQR: 3.5, 44.5) in the intervention arm. The ratio of the annual recruitment rate of new trial recruits at the intervention sites compared to control sites in 2013 adjusting for 2012 numbers and institution type was 0.99 (95%CI: 0.69, 1.43, p = 0.96). We found no evidence of a differential intervention effect across strata of higher pretrial recruitment ( 2 3 = 2.27, p = 0.5). The survey revealed most intervention sites utilized funds for increased staffing. Conclusions: Additional funding at a site level did not lead to a contemporaneous increase in trial recruitment. A lag‐effect may become apparent. In our setting, simply providing more funding without targeting and managing its use does not immediately increase trial accrual.