Delivering on the Promise of Decentralized Trials: Unexpected Perspectives from Clinical Research Professionals
This special report, published in November 2022, is the first to document ACRP members’ and stakeholders’ perspectives on the realities of implementing decentralized approaches at clinical study sites.
Based on the results of a first-of-its-kind survey compiling responses from 291 clinical research professionals employed at clinical trial sites in a broad range of roles, the survey reveals:
- DCT Technology Utilization Lags Behind Other Trial Technologies: For example, less than one-half of sites report currently running trials that use DCT components or services, and sites rarely use remote technologies that could support patient convenience.
- DCT Technologies Seem to Be an Encumbrance Rather Than an Enabler: For instance, sites that use DCT elements spend more time on trial delivery activities than sites not using these technologies. In addition, some sites need frequent support and experience issues collaborating with stakeholders on DCTs.
- Site Perceptions Strongly Influence DCT Acceptance: Many technologies are not single sign-on (SSO)-enabled, requiring multiple passwords and log-in procedures. Sites report that they would benefit from additional training and budget to implement DCTs effectively.
“As the non-profit association representing the clinical research profession, ACRP is committed to ensuring that study teams’ perspectives are considered as part of transforming clinical research,” says Susan Landis, ACRP Executive Director, in a November 30 press release announcing the report. “DCT approaches rely on principal investigators and study teams being able to incorporate decentralized approaches without impacting safety or quality. Therefore, the clinical research industry must consider the real-world experience of clinical research professionals at the site level for DCTs to be successful. With our combined survey and think tank approach, ACRP has crystallized the realities of implementing DCTs and identified areas where pragmatic solutions can accelerate this promising way of conducting trials.”
Sponsored by Medable and Advanced Clinical, the survey found that almost one-half of sites currently have no trials using DCT elements, with most others using such elements for only a small proportion of their trials.
Among survey respondents, the vast majority work with multiple sponsors (96%) and have 10+ trials under way (57%). Some 47% are study coordinators, 29% are research managers or directors, 44% are at academic institutions, 21% at private practices or clinics, and 21% at research-only sites. A total of 59% conduct activities onsite only, with 38% using a hybrid of both onsite and offsite activities.
ACRP Views on FDA Draft Guidance on Decentralized Clinical Trials
This blog provides viewpoints from senior ACRP members on the FDA document, titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Guidance for Industry, Investigators, and Other Stakeholders, published on May 2, 2023.
