Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms

Abstract

Decentralized clinical trials (DCTs) leverage digital technologies to reduce dependency on study sites and intermediaries. DCT should be balanced with accessibility and data reliability while meeting regulatory requirements. Here, we conducted a pilot study for functional constipation symptoms to investigate the feasibility of DCT. The study was an open, fully remote, randomized clinical trial in participants who had functional constipation symptoms. Electronic consent was obtained remotely, and study volunteers were screened through web‐based questionnaires. Subjects were randomized to either receive Lactobacillus and vitamin C supplements or vitamin C alone in a 1:1 ratio, which were delivered directly to subjects. Subjects kept track of bowel diaries daily during the 1‐week baseline and 2‐week treatment period using mobile applications. Bowel symptoms and the validity of the records were descriptively evaluated. A total of 30 subjects were randomized and completed the study. A total of 26.7% of subjects resided outside of the metropolitan area. Two‐week Lactobacillus treatments increased the number of defecations (+0.80 vs. +0.46 times per week) and decreased the defecation time (‐3.94 h vs. ‐1.62 h) compared to the comparator group. Overall, 67.1% of bowel diary records were completed in accordance with the schedule while 32.9% were not. Implementation of DCTs can facilitate geographic accessibility but should be guaranteed for data reliability. Prompt detection of errors and response using objective metrics would be required.

Establishment of Advanced Regulatory Innovation for Clinical Trials Transformation (ARICTT): a multi-stakeholder public-private partnership-based organization to accelerate the transformation of clinical trials

“…The first IIT addressed a fully DCT, with a trial design without visits to the trial sites. The detailed design and the result of the study are described in the literature [ 25 ]. The IIT was intended to evaluate the practical feasibility of DCTs within the current regulatory landscape in Korea.…”

“…One of the major efforts ARICTT has made is to bolster the engagement of patients. Considering the feasibility IIT for DCTs, we attempted to evaluate patient experiences in DCTs [ 25 ]. In addition, at the second year of ARICTT, we arranged a focus group interview for trial participants in an exploratory effort ( unpublished ).…”

The landscape of decentralized clinical trials (DCTs): focusing on the FDA and EMA guidance

“…There are still concerns that patient safety or data integrity could be compromised due to decentralized elements [ 27 28 ]. Security, compliance with local regulations, and delegation of the study personnel are also critical for DCTs.…”