Abstract P5-13-06: Analysis of barriers to clinical trial accrual in an NCI-designated comprehensive cancer center: Results of identifying clinical trial gaps
Authors: Dayao Z , Nemunaitis J 
Published: May 2019

Background: NCI-designated centers struggle to meet the 10% minimum accrual benchmark even for common malignancies such as breast cancer. The University of New Mexico Comprehensive Cancer Center (UNMCCC) average annual breast cancer trial accrual rate is approximately 11%, despite an average of 20 open breast cancer trials. Many published barriers were perceived to account for UNMCCC's low accrual including suboptimal screening, patients' unwillingness to participate, and disparities arising from socioeconomic and cultural barriers related to the large minority patient population. We sought to identify the true barriers to breast cancer therapeutic trials accrual to strategically formulate targeted solutions.

Methods: In 2016, a retrospective study was performed to review all breast cancer patients from UNMCCC's 2014 NCI Data Table 3. Barriers were classified into (a) trial specific, in which no trial was available or the patient was ineligible (b) patient specific, in which an appropriate trial was available but the patient declined participation (c) provider specific, in which screening was not documented.

Results: 145 cases were retrospectively evaluated. 6% declined participation, 13% were ineligible and 4% were not screened. Only 11% were enrolled in the 21 open trials.

No trial was available for 66% of patients. Out of this group, the majority of cases (68%) were stage 0/ I/ II (DCIS 12% LCIS 4%, stage I/II node negative, HR+, Her2- 52%), 17% were triple negative and 15% were HER2 positive.

The findings showed that despite the extensive clinical trial menu, the trials did not in fact adequately match the majority of the patient population who largely had early stage disease. This was identified as the main barrier to accrual. This resulted in a change in trial prioritization. Previously, the majority of trials were for advanced disease. From 2016-2018, the priority shifted to opening trials focused on early stage HR+, Her2 negative population. Investigator initiated, pharmaceutical, NCTN trials and symptom control trials for this population were opened.

As of December 2017, Data Table 3 accrual showed that 19% (70/353) new breast cancer patients were enrolled. This represents an increase in accrual from 11% to 19 %. Of these, 28% (20/70) had early stage HR+ Her2 negative disease.

As of 2018, therapeutic trials that include early stage HR+, Her2 -, node negative disease now comprise 30% of the UNMCCC breast cancer trial menu.

Conclusion: Detailed analysis of UNMCCC's breast cancer Data Table 3 showed that contrary to prior perceptions, the main accrual barrier was not ineffective screening, patient ineligibility or unwillingness to participate. The main barrier was that the extensive trial menu did not match the patient population. A large gap in the clinical trial menu was identified.

Published barriers to clinical trial accrual may not necessarily hold true for a specific institution. A disease-specific root cause analysis can facilitate development of tailored solutions. A shift in strategy in trial prioritization resulted in an increase in annual breast cancer trial accrual from 11% to 19%.

Citation Format: Dayao Z, Nemunaitis J. Analysis of barriers to clinical trial accrual in an NCI-designated comprehensive cancer center: Results of identifying clinical trial gaps [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-13-06.