Expanding rural access to phase I clinical trials.
Authors: Powell Steven Francis , Bleeker Jonathan , Sumey Christopher Joseph , Vogel Staci , vanDonkersgoed Sherra , Atkins Kristi , Ellison Christie , Hove Jenna , Black Lora Jane , Waggoner Jill , Kelley Jacqueline , Bell Maria C 
Published: June 2023

e18525

Background: Rural cancer patients (RCPs) represent 15-20% of those diagnosed with cancer in the United States (US). RCPs experience decreased access to oncology specialists, increased travel burden, and limited access to clinical trials, as well as unique socioeconomic factors that adversely impact their cancer outcomes. Phase I clinical trials often require complex coordination, frequent follow-up visits, and specialized support staff traditionally limiting access to larger, urban centers. Inclusion of RCPs on these trials can broaden understanding of these therapeutics early in their development. Methods: Starting in 2015, our community oncology program initiated a phase I center dedicated to improving access to RCPs. We evaluated enrollments, patient characteristics, residential location (metro vs. non-metro) as defined by the US Federal Office of Rural Health Policy (FORHP), medically underserved area (MUA) status as defined by the US Health Resources & Services Administration (HRSA), and clinical trial characteristics from April 2015-January 2023. Trials included were phase I, phase IB, or phase I/II trials with safety and/or dosing as the primary endpoint, as well as pharmacokinetic and/or pharmacodynamic secondary endpoints. Our primary outcome was the proportion of FORHP-defined rural participants enrolled. Secondary outcomes included treatment-related deaths and percentage of participants lost to follow-up. Descriptive analysis of patient and clinical trial characteristics was performed. Results: During the analysis period, 21 clinical trials meeting the inclusion criteria were opened. 218 participants were enrolled. Of these participants, 114 (52.3%) resided in FORHP-defined rural locations (89.5% non-metro and 10.5% metro). 23.9% resided in HRSA MUAs. Average distance traveled to our center was 76.1 miles (range 0.4-483 miles). Of these participants, there were no treatment-related deaths. 5 patients (2.3%) were lost to follow-up on study, all during long-term follow-up. Median age of participants was 62 years (range 33-85). 59.2% were male and 40.8% female. Races represented in the studies included: 95% White non-Latino, 2.3% Native American, 0.9% White Latino, 0.5% African American, 1.4% declined/not reported. Common disease sites treated included: 39.9% head and neck, 17.4% non-small cell lung, 11% pancreas, 5.5% melanoma, 5% colorectal, 4.6% breast, and 3.7% ovarian. Of the 21 clinical trials, 38.1% were phase I, 19% were phase IB, and 2.9% were phase I/II. Conclusions: Our center successfully and safely implemented a community-based phase I program with over half the participants enrolled from rural areas. Despite long distances traveled and high rates of rural residency, there were no treatment-related deaths and excellent follow-up rates. These findings support efforts to expand access to phase I trials in a rural setting.