Considerations on the implementation of DCT: a SCAT-based analysis of fact-finding interviews in Europe and the United States, with implications for regions newly adopting DCT, including Japan.

ABSTRACT:

Introduction

Decentralized clinical trials (DCT) are becoming more common. In regions where DCT will be widely adopted, including Japan, issues in implementing DCT must be identified and addressed.

Materials and methods

In this study, we interviewed the clinical development staff at pharmaceutical and medical device companies, or clinical research organizations in Europe and the United States and then analyzed their information to understand the transition to and current status of DCT from a practical perspective. Steps for Coding and Theorization qualitative data analysis was used.

Results

DCT, along with the rapid digitisation of medical care, occurred in some institutions because of the novel coronavirus disease pandemic. Our results confirmed that introducing DCT

SUBMITTER: Taruno H 

PROVIDER: S-EPMC12616372 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature