Protocol requirements and logistical intensity of early-phase clinical trials (EP-CTs).

Abstract

e18609 Background: EP-CTs are increasingly important options for patients with cancer and often involve intensive monitoring. Characterizing the time burden and logistical intensity of EP-CT protocols could help patients and clinicians make informed decisions about trial participation. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs at Massachusetts General Hospital from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), EP-CT investigational agent (immunomodulatory [IM], targeted inhibitor [TI], antibody drug conjugate [ADC]/chemotherapy prodrug), and logistical intensity (visit frequency required per protocol and presence of extended visits). We defined visit frequency as the number of visits required per protocol within the first 28 days on trial. We defined an extended visit as six or more hours required in clinic on at least one day during the first 28 days on study. We evaluated associations among patient characteristics, investigational agents, logistical intensity, and time spent on trial. Results: Among 421 patients (median age = 63.0 years, 56.9% female, 97.6% metastatic disease), 43.2% were enrolled in IM EP-CTs, 43.0% TI, and 13.8% ADC/chemotherapy prodrug investigational agents. Patients enrolled on ADC/prodrug trials had the highest burden of metastatic disease (mean sites: 2.8 [ADC] vs 2.4 [TI] vs 2.3 [IM], p = 0.007) and oldest age (mean years: 64.0 [ADC] vs 61.7 [IM] vs 58.5 [TI], p = 0.003). However, those on ADC trials had the most days spent on trial (mean days: 78.3 [TI] vs 102.2 [IM] vs 131.8 [ADC], p = 0.003). Patients enrolled on TI trials had the highest required visit frequency compared with those enrolled on other trials (mean visits: 5.5 [TI] vs 5.3 [ADC] vs 5.0 [IM], p = 0.027). Additionally, those on TI trials were most likely to have an extended visit (82.3% [TI] vs 58.2% [IM] vs 29.3% [ADC], p < 0.001) and least likely to receive first in human therapy (38.1% [TI] vs 74.1% [ADC] vs 74.2% [IM], p < 0.001). Conclusions: In this cohort of patients participating in EP-CTs, we found that those enrolled on TI trials had the highest per protocol visit frequency and greatest likelihood of required extended visits. Those on ADC trials spent the most days on trial despite having the highest average age and burden of metastatic disease. These data highlight the time burden and logistical intensity of EP-CTs, underscoring certain trials as especially time intensive, which may help inform trial selection and participation.