Innovative Trial Design Using Digital Approaches: An Example From Reproductive Medicine [21I]. (May 2020) - Hamvas, Györgyi
Abstract : INTRODUCTION: Loss to follow-up and missing data are common reasons why clinical studies fail. In a site-less digital clinical trial we assessed the accuracy of a wearable fertility tracker, where we examined participants' retention, compliance, and satisfaction with the site-less design. METHODS: In this IRB approved study, participants were recruited remotely through social media, online platforms, and email invitations. Participants wore the Ava Fertility Tracker for up to 6 menstrual cycles, took body temperature and urinary luteinizing hormone tests. We collected all self-reported outcomes and wearable device data via a mobile app, wherein the study coordinator could monitor compliance and send participation reminders. An independent customer support team provided technical support. Participants gave input on the site-less study design via an online survey. RESULTS: Fifty-six Swiss women completed the satisfaction survey (85% of the 66 enrolled study participants), rating their experience with social media recruitment (83%), online registration (98%) and online invitations (98%) as good or very good. Almost two-thirds of respondents considered the trial design easy to integrate into their everyday life. Most participants were highly satisfied with the technical support (78%), while 98% reported the study coordinator's remote support as very helpful. CONCLUSION: Our predominantly digital approach resulted in high rates of completion (92%) and procedural compliance (87%), while maintaining participant satisfaction. This suggests site-less designs in reproductive health research could increase the quality and quantity of clinical data collected while minimizing participation burden. Future replication studies with longer follow-up times should consider whether the sampled population is biased towards digital natives.