ACRP Documents Members’ and Stakeholders’ Perspectives On the Realities of Implementing Decentralized Approaches at Sites
Lack of clarity around regulatory requirements is the leading barrier to adopting decentralized clinical trials (DCTs) at the site level, according to participants at a think tank convened by the Association of Clinical Research Professionals (ACRP). Other top barriers include lack of budget flexibility and the challenges of managing third-party vendors – input that contrasts with widespread thinking that technology is a primary barrier to adoption of DCT approaches in clinical research.
Titled “From Trepidation to Trust: Documenting the Realities of Hybrid and Decentralized Clinical Trials Adoption,” the think tank, held in person on October 20, 2022, included 42 participants from multiple clinical trial stakeholder groups, including sites, clinical research organizations, academic research organizations, healthcare providers, pharmaceutical companies, and regulators. The think tank was conducted with educational sponsorship funding from Medable, Inc., Advanced Clinical, and Syneos Health. ACRP plans to release a full report from the think tank early in 2023.
The findings add to data from a newly published ACRP membership survey focused on DCTs, entitled “Delivering on the Promise of Decentralized Trials: Unexpected Perspectives from Clinical Research Professionals.” The survey was fielded online from August 24 to September 14, 2022 and was sponsored by Medable and Advanced Clinical. Based on responses from 291 clinical research professionals employed at clinical trial sites, from a broad range of site roles, the survey revealed:
- DCT technology utilization at sites lags behind other trial technologies.
- Sites that use DCT elements actually spend more time on trial delivery activities.
- Site personnel perceptions of DCT elements strongly influence DCT acceptance.
“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. “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.”
Survey Highlights Limited Site Uptake and Impacts of DCT Technology
The ACRP member 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.
Three overall themes emerged from the survey:
- 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.
Supplementing Survey Results with Discussion
The goal of the ACRP think tank was to discuss and document the barriers to adopting DCT and hybrid components in clinical trials from the perspectives of research sites and clinical research professionals. In discussions, participants agreed that while DCTs should in theory decrease the site burden, in reality the opposite is true. Based on a poll taken during the think tank, participants identified the top barriers to implementation of DCT elements as:
- Regulatory requirements: These include a need for harmonized global expectations and clarity about who accepts oversight liability for remote elements, how data should flow, and where new methods and technologies fit. Process mapping will be a key tool in ensuring appropriate use of technology-supported solutions.
- Budget adaptations: Flexibility is needed to ensure that budgets reflect the true costs of DCTs. For example, traditional visit-based budget modules do not account for remote visits that take place in hybrid trials, and do not reflect time required for training and change management. Sites are well known to suffer from cash flow volatility, and some are “quiet quitting” due to budget shortfalls.
- Managing third party vendors: Sites should have flexibility to choose their own vendors for DCT-related elements, rather than having these imposed on them. This is particularly important for vendors who offer services at patients’ homes since the principal investigator is accountable for patient safety.
These insights provide a new, broader perspective of the many challenges that must be addressed at site level, where day-to-day trial activities take place, to accelerate DCT adoption. While technology adoption is demanding, with a significant burden relating to technological support and integration, this in itself is not a primary barrier. The human element is key, with a need for implementation of processes that allow for the successful conduct of clinical trials leveraging the available solutions.
Holding the think tank and fielding the new survey advance both the ACRP mission to promote clinical research professionalism and the vision that clinical research must be performed ethically, responsibly, and professionally everywhere in the world.
Join Discussions to Advance Decentralized Trials
At ACRP 2023, April 28-May 1, 2023, Dallas, TX, you’ll find expertise and insights to support your professional development and help ensure quality and integrity in the clinical research process. And don’t miss your chance to participate in FIVE sessions that will delve into the realities, challenges, and opportunities in conducting DCTs.
- Decentralized Trials: Between Hype & Hope – Discus the results of our community survey and white paper about DCTs, and hear perspectives brought forward from the ACRP DCT Think Tank, sponsored by Advanced Clinical, Medable, and Syneos.
- A Patient-Centric Approach to DCTs – Gain a more holistic sense of the challenges that we face, and the amazing possibilities as clinical trials increasingly move towards DCTs.
- DCTs: From Barriers to Best Practice – Discuss the on-the-ground realities of adopting DCT components and hear solutions for empowering study teams to transform clinical research.
- DCTs of the Future: The AMC Outlook – Hear practical suggestions for designing and executing digital and hybrid DCT approaches outside of the traditional brick-and-mortar site.
- DCT Models: Are They Here to Stay? – Designed for clinical research professionals in biopharma companies, academic, and community-based sites currently adopting the use of decentralized models. Guidelines, tools, and suggested workflow templates will be provided.