SUMMARY ANSWER: Despite the short duration, the NCCCP pilot resulted in an increase in the number of open trials and patient accrual at a faster rate than that observed nationally. These results, coupled with insights into the relative success of sites with varying sophistication at the outset, provide promise that lessons learned can be applied more broadly to increase research participation.METHODS: Self-reported data from 2007 to 2010 were aggregated from NCCCP sites and supplemented by data from the NCI Cancer Therapy Evaluation Program, which were then analyzed to assess the impact of the NCCCP on key metrics.
RESULTS (OR WHAT WE FOUND):Trial availability and accrual improved more quickly at NCCCP sites when compared with national trends. Phase III trial availability increased 8% nationally versus 16% across NCCCP sites. Accrual to phase III trials increased by 30% nationally versus 133% across NCCCP sites. Accrual of racial and ethnic minorities rose 82%, from 83 to 151 patients, and accrual of patients age $ 65 years rose by 221%, from 200 to 641 patients. Change in trial portfolio and accrual differed by sites' sophistication and prior experience in conducting clinical trials.
BIAS, CONFOUNDING FACTOR(S), DRAWBACKS:Ideally, there would be the opportunity to generate this analysis in a randomized, controlled fashion. Unfortunately, no national data set exists and it was not the purpose of the NCCCP approach. Three years is a short timeframe and a relatively small number of sites were involved.
REAL-LIFE IMPLICATIONS:Despite the short duration of the NCCCP pilot phase and the limited resources provided, the NCCCP pilot supported progress in sites' clinical trials programs as evidenced in their ability to open clinical trials and to accrue greater numbers of patients. Sites with less infrastructure and experience with clinical research can see large increases in enrollment in later phase trials with modest investment and mentoring. On the other hand, more operationally advanced sites may have maximized this capacity, but can see increases in underserved accrual and the initiation of earlier phase trials (Fig 2). National investments like the NCCCP have the potential to improve care for patients treated in community settings by bringing more clinical trials to community-based settings and involving greater numbers of patients among underserved communities.
Materials and MethodsWe examined self-reported data from NCCCP sites during 2007 to 2010, supplemented with data from the National Cancer Institute Cancer Therapy Evaluation Program.
ResultsTrial availability and accrual improved more quickly at NCCCP sites compared with national trends. Phase III trial availability increased 8% nationally versus 16% across NCCCP sites, and accrual increased 30% nationally versus 133% across NCCCP sites. Accrual of racial and ethnic minorities rose 82%, from 83 to 151 patients, and accrual of patients age $ 65 years rose by 221%, from 200 to 641 patients. Change in trial portfolio and accrual differed by sophistication of...