A randomised controlled trial to improve enrolment to cancer clinical trials

Background: The proportion of adults with cancer recruited to clinical trials is low. Cancer Council Victoria awards funding to 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 growth or stability in new patients recruited. We undertook a RCT to evaluate the hypothesis that additional funding would improve recruitment. Methods: Participating sites (n = 34) were stratified into four strata based on 2011 recruitment. Control sites (n = 18) received usual CTMS funds, 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 an average 11.8% (IQR: 8%, 12.3%) increase in the site's total budget. Additional funds were provided in early 2013. Sites were required to use the 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 2012. Negative binomial regression analysis was used to model the endpoint, adjusting for any imbalances in the groups'. An online survey assessed 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 pre‐trial recruitment (χ23 = 2.27, p = 0.5). The survey revealed most intervention sites utilised funding to increase staffing. Conclusions: Additional funding at a site level did not lead to a contemporaneous increase in 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.