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Retention by Design: Operationalizing Patient-Centric Trials Without Increasing Site Burden
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Retention by Design: Operationalizing Patient-Centric Trials Without Increasing Site Burden
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Journal Article
Retention by Design: Operationalizing Patient-Centric Trials Without Increasing Site Burden
2025
Overview
Regulatory-quality outcomes and statistical validity depend on participants staying until endpoint assessments are completed.1 When large proportions of patients drop out, the study loses power to detect treatment effects, wasting the efforts of those who did participate and often forcing costly extensions or protocol amendments. The reasons are diverse- disease burden, adverse events, lack of perceived benefit, logistical and personal hardships can all play a role.2 Surveys of trial participants consistently find that burdens and inconveniences are top drivers of dropout.2 For instance, travel to the study site is often cited as the No. 1 burden contributing to discontinuation, especially when participants must travel long distances or take time offwork repeatedly.2 Complex visit schedules, long waits at clinics, language barriers, and cumbersome trial procedures can all erode a participant's motivation to continue. Trials increasingly span global populations, and even within one country there may be substantial language diversity.1 Providing study materials, app interfaces, and support in each participant's preferred language is not just a regulatory box-check -it's fundamental to retention. [...]a retention-focused trial design embraces flexibility: offering remote visit options, local labs or healthcare provider visits, and in-home services when feasible.4 The COVID-19 pandemic accelerated the acceptance of decentralized trial elements, and now we see their lasting benefit for retention.â For example, if a participant can do a telemedicine visit for a routine check-in or have a home health nurse come to draw blood, they are less likely to withdraw due to travel burden or schedule conflicts. †Integrated reminders and participant support Forgetfulness and feeling \"out of the loop\" are common contributors to non-compliance and drop-out .3 Participant-centric trials, therefore, proactively support participants with integrated reminder systems and open lines of communication.
Publisher
MultiMedia Healthcare Inc
Subject
