Optimizing a team approach for successful accrual to and conduct of clinical trials in a community oncology practice

ABSTRACT

Background: Oncologists and advanced practice providers (APPs) routinely work as part of a team to provide quality cancer care in today's healthcare environment. However, this does not always translate into the realm of clinical research. It is estimated that only 2-8% of the adult oncology population enrolls in a clinical trial, with more than 20% of current trials failing to meet accrual goals. These numbers are projected to be even worse due to the impact of the COVID pandemic. Our Oncologist/APP team in conjunction with a clinical research coordinator (CRC) set out to develop a workflow to approach and offer clinical trials to patients in our practice with the goal of increasing clinical trial accrual and improving clinical trial conduct. Methods: Between 1/1/19-12/31/21, a community breast oncology focused practice in the Hawaii M/U NCORP implemented a plan with the goal to increase accrual to clinical trials. Building on the prior experience of both clinicians, the practice developed a comprehensive team approach between the Oncologist, APP, and CRC. This approach included four components 1) Clinic workflow for clinical trial screening, introduction, and follow-up of potential participants;2) Shared clinical trial visits between MD & APP;3) Protocol reviews by MD who reviewed treatment protocols & APP who reviewed symptom management and cancer care delivery research (CCDR) protocols. All clinical trial reviews were discussed with CRC for coordination input;4) Protocol leadership between MD serving as local primary investigator (PI) on treatment trials, APP serving as local PI and/or site champion on symptom management and CCDR protocols. Results: From 2019- 2021, our practice was able to accrue over 23% of our patients to clinical trials in a community practice setting, despite the COVID-19 Pandemic. Of the 149 unique accruals during this period, 59% of accruals were interventional trials and 41% were observational trials. Clinical trial accrual was racially diverse and mirrored the patient population. During this period, there were minimal protocol deviations observed based on review of shadow charts on this group of clinical trial patients. Conclusions: Through this team approach, our practice has been successful in having a high rate of clinical trial accrual while maintaining excellent clinical trial conduct even during the pandemic. We believe our team approach that utilizes the APP to the full scope of practice along with CRC empowerment in addition to the engaged oncologist is key to our success. Oncology practices and healthcare systems must value and engage all potential members of the team to maximize their clinical trial ability and to continue to offer/ enroll patients in clinical trials as the standard of care.