Feasibility and impact of conducting a phase 1 clinical trial throughout the regional network of an academic cancer center.

133 Background: When cancer becomes resistant to standard therapies, phase 1 clinical trials represent a potential treatment option for those who are eligible and willing to pursue further cancer-directed therapy. However, participating in phase 1 trials requires substantial time and resources, often necessitating travel exceeding 25 miles or more than one hour each way to the trial site. We evaluated the feasibility and effects of decentralizing a phase 1 clinical trial by bringing the study closer to patients via the community-based regional care network (RCN) of Memorial Sloan Kettering Cancer Center (MSKCC). Methods: We conducted a phase 1 trial of an oral drug in dose expansion phase at 7 outpatient locations of MSKCC, comprising 1 site in Manhattan, 3 RCN non-Manhattan sites in New York and 3 RCN sites in New Jersey, and assessed feasibility of phase 1 trial conduct in community-based setting. Ten site visits were required in the first 7 weeks for laboratory and pharmacokinetic assessments. Apart from optional tumor biopsies, all trial-related activities could be conducted at any site. Telemedicine was allowed for informed consent and toxicity assessments per investigator’s discretion. We assessed the impact of bringing the study closer to patients by comparing unidirectional traveling time and distance from patient's home to the Manhattan site with unidirectional traveling time and distance from patient's home to the actual treatment site. Results: Eight patients were accrued within 6 months from 4 sites, including 3 (37.5%) from Manhattan and 5 (62.5%) from the RCN. The enrolled participants had median age 50.5 (range 34-76) years, and included 3 (37.5%) females, 2 (25%) non-English speakers, and 4 (50%) non-Hispanic White patients. One patient accrued from the Manhattan site transferred to an RCN site closer to home. Two patients accrued from one RCN site were transferred to another site (1 Manhattan, 1 RCN) due to scheduling constraints at that site. The median unidirectional traveling distance and time from home address to the treatment site was 8.6 (interquartile range IQR 6.6-13.4) miles and 26 (IQR 19-47.5) minutes, respectively, which decreased from 27.3 (IQR 14.8-39.9) miles and 75 (IQR 55-102.5) minutes, respectively, from home to the Manhattan site if the trial had not opened in the RCN (Wilcoxon signed rank P = 0.043 for both). Half of the informed consent visits and 10.4% of the toxicity assessment visits were conducted via telemedicine. No patient withdrew consent during treatment (retention rate of 100%). Conclusions: Conducting a phase 1 study with pharmacokinetic assessments is feasible in the RCN. Bringing the clinical trial closer to patients significantly decreases travel time and distance, and allows efficient accrual of a demographically broad group of participants.