114: A Clinical Study to Evaluate the Feasibility of Decentralized Clinical Trial Elements in Korean Patients

Statement of Purpose: Decentralized clinical trials (DCTs) leverage digital technologies to reduce dependency on study sites and intermediaries. A DCT should maintain a balance between accessibility and data reliability while meeting regulatory requirements. This study was conducted to evaluate the feasibility of various DCT elements and also suggest issues related to DCT components, through a pilot remote study in South Korea. To minimize regulatory issues, a non-IND study was planned in which patients with mild constipation were treated with dietary supplements.

Description of Methods & Materials: The study was an open, fully remote, randomized clinical trial in participants who had functional constipation symptoms. Subjects were recruited through websites and consent was acquired electronically. Screening procedures were performed through web-based questionnaires. Eligible subjects were randomized to receive either probiotic supplements (lactobacillus) or placebo in a 1:1 ratio. In order to evaluate treatment compliance, vitamin C was administered in both treatment groups. Urine vitamin C self-test strips (Self-Stik Vita-Check, Chungdo Pharmaceuticals, Korea) were delivered directly to the subjects along with the treatments. Stool collection kits (Gut Inside, CJ Bioscience Inc Korea) were sent to the subjects’ homes to evaluate the changes in the microbiome, and their stool specimens were returned to the laboratory on the last dosing day. Subjects kept track of bowel diaries based on relaxed Rome III criteria daily during the one-week baseline and two-week treatment period using mobile phone applications. Subjects also recorded a medication diary and urine vitamin C self-test results during the treatment period. Bowel symptoms and the validity of the records were evaluated descriptively.

Data & Results: A total of 30 subjects were randomized and completed the study. Among them, 26.7% resided remotely from Seoul metropolitan area. The average delivery time was 21.3 hours and there was no loss of packages in either medications or specimens. The fraction of data recorded within the scheduled time window was 63.8% for the medication diary, 67.1% for the bowel symptom diary, and 76.9% for urine vitamin C strip test results. The lactobacillus treatment improved defecation frequency (+0.8 vs +0.46 time per week) and duration of defecation (-3.94 h vs -1.62 h). Among the nine stool specimens submitted, the mean gut microbiome index was higher in the lactobacillus.

Interpretation, Conclusion or Significance: The remote nature of this DCT diversified the geographical location of the study participants. This type of DCT design would be suitable for chronic diseases that require frequent monitoring. As the recruitment and data collection process can be influenced by various unexpected factors such as device heterogeneity, the software interface should be carefully designed to provide reliable data collection. Although all the participants were informed of the study procedures, individual understanding and/or responses were not satisfactory on some subjects. Systematic approaches to monitor trial procedures such as artificial intelligence-based analytics will be needed to enhance subjects’ adherence and compliance to study procedures. Implementation of DCTs can facilitate geographic accessibility, but detailed measures should be utilized to ensure data reliability. Systematic supervision of study procedures should be provided with objective adherence metrics.

Disclosures: The authors have no conflict of interest in the study.