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P218: Decentralized Mobile Visit Services for Rare Diseases: Amyotrophic Lateral Sclerosis

Poster Presenter

Kurt Lumsden

Head, Global Operations
Fortrea
United States

Objectives

To show the applicability and patient acceptance of Hybrid Decentralized Clinical Trials, and specifically Remote Study Visits in ALS Clinical Trials.

Method

For a Phase III trial, between 1 June 2021 and 5 March 2023, Labcorp conducted 1033 visits for 97 adult patients across North America, Europe and APAC, enrolled at 19 sites (n=27), representing 64.7% of total patients (n=150) using a hybrid DCT approach with optional remote visits.

Results

Remote Study Visits have been completed in the US, Australia, Canada, France, Germany and Japan for patients diagnosed with ALS and enrolled in a three-year long Phase III trial with frequent assessments, who had consented to utilize the option of remote study visits. These mobile visits occurred either at screening or monthly after randomization (up to 37 visits per patient), and involved: • Scheduling of the visit with the patient • Biologic sample collection, processing, packaging and shipping to the Central Laboratory via specialty courier (Involving both ambient and frozen samples) • Assessment of changes in Signs and Symptoms • Assessment of changes in Concomitant Medications • Visit Documentation • Communication with the Investigator Site Patients suffering from ALS experience difficulty walking and conducting activities of daily living, general weakness and are at risk of falling and tripping (1). As with other rare disease studies, patients frequently do not live near the investigator site, and that combined with the frequency of study visits over the duration of the trial, participation and retention could be challenging for the patient population. In this case, the majority of sites (70.3%) accepted the service, and the majority of patients (64.7%) agreed to the option of home visits.

Conclusion

Remote study visit services have long been utilized in hybrid Decentralized Clinical Trials, notably those studying patients diagnosed with rare diseases such as Amyotrophic Lateral Sclerosis (ALS). These services are essential in reducing the patient burden for patients with this diagnosis who can face mobility or endurance challenges. Mobile Visit services, even when not utilized by every patient, can be an effective and well accepted option for patients enrolled in clinical studies of ALS. They represent an important decentralized clinical trial approach to support patient recruitment, retention and engagement through the reduction of the patient participation burden, and by so doing, enabling achievement of project timelines. Additionally, this methodology, long employed in North America, LATAM and EMEA, is now also being utilized in APAC. Bibliography: 1. https://www.mayoclinic.org/diseases-conditions/amyotrophic-lateral-sclerosis