Patient insights into decentralization of a clinical trial in asthma (TANGO)

<bold>Background:</bold> Clinical trial decentralization (remote patient assessments) has increased in prevalence, in part, triggered by the COVID-19 pandemic. Decentralized elements are captured via digital solutions, raising the question whether patients are receptive to this technology and capable of utilizing it as clinical trial participants. We conducted a survey to better understand asthmatic patients’ perspectives toward the use of clinical trial decentralization. Method: A qualitative research study with semi-structured interviews was conducted in asthma patients in 4 countries (Argentina, Germany, Poland, South Korea). The discussion guide was based upon the ongoing Phase II tanimilast asthma study (TANGO) presented to patients as a hypothetical trial. Decentralized elements discussed included eConsent, home spirometry, eDiary and televisits. <bold>Results:</bold> Sixteen patients (75% female, mean age, 43 years) were interviewed. Travel times to reach their Health Care Provider (HCP) varied between 12 and 73 min one way (avg. 30 min). 87% of participants liked the idea of eConsent, particularly the video content. 87% were willing to complete a daily eDiary; hesitant patients were few (n=2) and over age 65. 81% expressed comfort with using a home spirometer if sufficient instructions were provided and results conveyed to HCPs. 94% of participants found televisits acceptable, the majority having experienced this modality during the COVID-19 pandemic. <bold>Conclusion:</bold> Decentralised elements are generally well accepted by patients when the approach is clearly explained to them. Such solutions may decrease patient burden, and in some cases provide access to clinical trials to patients who would otherwise not be able to participate.