Eligibility Criteria a Significant Barrier to Patient Enrollment in Oncology Clinical Trials

Use of an oncology clinical pathways system with embedded clinical trials was associated with a modest increase in patient enrollment. These findings were presented during the ASCO20 Virtual Scientific Program.¹

Enrollment in clinical trials continues to be a challenge in oncology, with only approximately 3% of adult patients with cancer treated within a trial. A key recommendation from the National Cancer Institute–American Society of Clinical Oncology cosponsored Cancer Trial Accrual Symposium: Science and Solutions in 2013 was to use information technology to enhance identification of patients who are potentially eligible for clinical trials.²

Researchers at Roswell Park Comprehensive Cancer Center (RP) in Buffalo, New York, assessed the effect of implementing an oncology clinical pathways system with integrated clinical trial information on patient enrollment, and categorized physician-identified reasons for nonenrollment. ClinicalPath pathways (formerly Via Oncology) was implemented in 2018.

The software embeds interventional clinical trials that are open to accrual at the cancer center into the clinical pathway specific to a patient’s disease type, stage, and biomarkers. The software lists relevant clinical trials before presenting standard care options, prompting the clinician to select screening for a trial or provide a reason for bypassing the screening from a drop-down list.

The researchers reviewed system-generated clinical trial screening requests from June 1, 2018, to May 31, 2019, matching screening requests with actual enrollment data. The accrual-to-study ratio (ASR), defined as the number of consented accruals divided by the number of clinical trials open to accrual at the cancer center at any time during the period, was calculated for the study period and a baseline period of June 1, 2014, to June 1, 2018.

Multiple trials can be presented for each pathway decision. For this study, 1606 decision points with at least 1 embedded trial were identified. Of these, 1289 decision points matched 2242 clinical trials that were not selected for screening. Among 317 trials that were selected for clinical trial screening, 108 patients were enrolled in a clinical trial. One year after implementation of the oncology clinical pathways system, the ASR increased from a 4-year historical average baseline of 4.08 to 4.33.

The most common reasons for not screening were patient ineligibility (41%), the clinician bypassed the clinical trial by selecting treatment “off pathway” (28%), the patient was not interested in trial participation (12%), the patient was already on a clinical trial (8%), and “other” (9%). Ineligibility was most often due to comorbidities such as organ dysfunction or brain metastasis that precluded the patient from trial participation.

The researchers concluded that the use of electronic intelligence only modestly increased ASR, and stringent eligibility criteria was the primary barrier to patient enrollment. They went on to suggest that adopting a broader set of eligibility criteria may improve enrollment in clinical trials.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.

References

1. McKinney M, Samborski C, Stefaniak, et al. Identifying and overcoming clinical trial enrollment barriers: can an integrated clinical pathyways tool help bridge the gap? Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 2046.

2. Denicoff AM, McCaskill-Stevens W, Grubbs SS, et al. The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations. J Oncol Pract. 2013;9(6):267-276.