Case Study

Preterm Birth

A BioTech Company's Solution to Delay Preterm Births

Challenge

This study aimed to evaluate the safety and efficacy of an advanced technology to delay preterm birth. The sponsor’s overall goal was to recruit 12 pregnant patients. The sponsor anticipated difficulty finding patients who would be willing to receive a treatment whose safety and efficacy had not yet been evaluated in humans. A major challenge was that patients needed to be recruited before week 18 of their pregnancies. The patients needed to be at risk for preterm birth based on previous pregnancies, or be expecting twins, which narrowed the pool of relevant patients in an already difficult-to-recruit population. The lengthy time commitment was another hurdle. Patients needed to commit to the study from the beginning of their 2nd trimester until delivery. Patients who were already experiencing one of the most overwhelming periods in their lives were asked to add 15 extra office visits to their busy schedules and regular prenatal visits.

Customized and Collaborative Approach

nRollmed’s strategy was to attract potential patients by approaching the strong online community of pregnant women, especially women who were at risk for an early delivery. nRollmed advertised the study in specific interest groups on social media and partnered with advocacy groups focused on preterm birth. Innovative methods were used to reach populations with high birth rates including those lacking a significant presence on social networks such as the ultra-Orthodox Jewish community. The patients who responded to the ads were provided with study information and were asked to complete an online questionnaire to check their compatibility. Next, they were referred to the study coordinator who continued the process. The nRollmed team fully supported the study coordinator and collaborated with them to optimize the recruitment process. nRollmed worked with the sponsor to have the study featured on a local news channel, to increase general interest in the study and awareness of the condition. A patient testimonial added to this news feature was especially compelling.

The nRollmed Method

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Results

nRollmed made a signiﬁcant impact on the study recruitment process, and operated an online advertising campaign and provided a suite of support services to the sponsor and the site’s recruitment staff. 429 interested patients were attracted by the online campaign. Of the 18 patients who were screened in-person, 14 were referred by nRollmed; ultimately nRollmed contributed 10 randomized subjects to the study. These 10 patients accounted for 83% of the total of 12 patients recruited, or 91% of all patients recruited in the time period that nRollmed was active. The
study’s recruitment rate was accelerated 10x with nRollmed’s help.

429

leads expressed interest in the study

91%

of recruits during 7 months' activity

10x

accelerated Enrollment Rate

nRollmed contributes 83% of subjects and speeds up Enrollment Rate by 10x

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