Is using a patient-centric digital referral partner for clinical trial recruitment worthwhile? Overcoming the limitations of traditional clinical trial recruitment methods. (Preprint)

Abstract

Inadequate clinical trial recruitment is a pain point that limits the success of clinical trials with targeted patient populations. Digital recruitment methods show promise in ameliorating the difficulties inherent in identifying eligible participants, but many innovative digital channels remain unexplored for this purpose. This study adopted a tailored, multi-channel digital recruitment campaign to expressly recruit females who experience urinary tract infection, via a condition-specific, patient-centred referral partner.

To evaluate the effectiveness of a multi-channel digital clinical trial recruitment strategy via a patient-centred referral partner, in increasing randomisations for a large-scale clinical trial.

The clinical trial comprised two phase 3 multicenter studies comparing a novel antibiotic for urinary tract infection with a standard medication. Clinical trial recruitment commenced in October 2019 and was supplemented by an additional digital recruitment campaign via a patient-focused referral partner for the final six months of the recruitment period, between May and October 2022. The multi-channel digital intervention comprised mass emails, browser notifications, email automations, high-traffic website announcements and organic social media posts. Interested candidates were prompted to click through to the study website. Performance of each channel was tracked using digital analytics tools.

The overall digital recruitment campaign click through rate exceeded industry standard response rates and the number of clicks was 2.76 times higher than the predetermined target, demonstrating the strength of implementing digital clinical trial recruitment via a referral partner with access to an online patient community. Of the 4829 candidates who clicked through to the study website during the referral partner campaign, the most successful channel in terms of clicks was website announcements (n=2537), followed by mass emails (n=1352), and email automations (n=653). The highest click through rate was achieved by an email automation sent to new mailing list subscribers. A Chi-square test of independence confirmed a statistically significant increase in the likelihood of candidates clicking through the direct funnel, when compared to the indirect funnel (P<.001). Innovative tracking methods were successful in gathering the data crucial for real-time campaign optimisation.

This study went beyond previous findings that email marketing is an underutilised tool with potential for clinical trial recruitment and established inventive new channels, including high-traffic website announcements, browser notifications, automated individual emails and organic social media posts, as effective means of reaching target patient populations. Furthermore, the study confirmed that a targeted digital recruitment campaign via an appropriate referral partner increased the rate of randomisations into the trial.

ClinicalTrials.gov: NCT04020341, NCT04187144; https://classic.clinicaltrials.gov/ct2/show/NCT04187144 and https://classic.clinicaltrials.gov/ct2/show/NCT04020341.