Impact of oncology clinical pharmacist intervention on clinical trial enrollment in The U.S. Oncology Network’s MYLUNG Consortium.

Abstract

1503 Background: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium (MYLUNG) clinical trial platform aims to advance the use of precision medicine in non-small cell lung cancer patients through a series of prospective and iterative clinic trials. “Protocol 2” is evaluating the patient and tissue journey of newly diagnosed lung cancer patients presenting for care. Timely patient accrual to oncology clinical trials is a known practice challenge. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) to provide remote clinical services to support Protocol 2 enrollment. Methods: An oncology-trained clinical pharmacist remotely reviewed chemotherapy regimen orders and a weekly custom recruitment report within six community network practices (n = 149 physicians). The ClinReview pharmacist identified, screened, and assisted with recruitment of eligible patients for enrollment in the MYLUNG study. Relevant and concise patient data were provided to the on-site research team to facilitate ease of enrollment. Enrollments and intervention data were tracked to monitor the impact of the pharmacist intervention. The primary outcome of monthly enrollment was evaluated using a paired t-test. Results: Over a 6-month period, the ClinReview pharmacist screened 367 potentially eligible patients, 325 patients were recommended for enrollment, and 103 patients (32%) were consented and enrolled. Enrollment due to this ClinReview intervention increased monthly and ranged from 5 in first month to 33 enrollments in month 6. Average monthly enrollment was significantly greater after ClinReview intervention (3.4 patients/month vs. 6.8 patients/month; p = 0.008). Of the 154 patients recommended for enrollment that were not enrolled, 104 (68%) exceeded their eligibility window allowed by the trial, 15 (10%) were deceased or enrolled into hospice care, 10 (6%) declined trial participation, and 25 (16%) transferred care or were treated at outside facilities. Conclusions: We demonstrate that incorporation of an oncology clinical pharmacist in clinical research teams significantly enhanced clinical trial enrollment. The remote pharmacist easily adapted into clinic workflows in community practices. Validation across a broader spectrum of differentially resourced oncology practices will be conducted as the MYLUNG clinical trials platform is executed. [Table: see text]