Additional Funding Intervention Trial (AFIT)

Is there a positive relationship between funding and participant accrual into oncology clinical trials? The results are now in.

An exploration of the relationship between funding and patient accrual to oncology clinical trials: Additional Funding Intervention Trial (AFIT)

Aim

Since 1988, Cancer Council Victoria's (CCV's) Clinical Trials Management Scheme (CTMS) has retrospectively awarded funding to departments coordinating oncology clinical trials. Analysis of the CTMS data, indicated there may be a temporal relationship between growth or stability in funding and gorwth or stability in the number of patients recruited to oncology clinical trials. To explore this relationship, the Clinical Network was awarded a $1M grant from the Victorian Cancer Agency to undertake a Randomised Controlled Trial to evaluate the hypotheseis that additional funding would improve trial recruitment.

Method

Participating sites (n=34) were stratified into four strata based on 2011 recruitment numbers. 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 was 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 recruitment in 2012.
Negative binomial regression analysis was used to model the endpoint, adjusting for any imbalance in randomised groups' features and historical recruitment. 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 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. Although there are limitations to the study, it's the first research study of its type internationally.

The Principle Investigator is A/Prof Jeremy Millar with Associate Investigators Ms Catriona Parker and A/Prof Ray Snyder.

The trial is funded by the Victorian Cancer Agency (VCA) and inā€kind donation of time by several Clinical Network and other Cancer Council staff.

For more information contact Cat Parker, Projects Coordinator - Clinical Trials at Catriona.Parker@cancervic.org.au.

 

Updated: 22 Jun, 2015