Clinical Researcher—August 2023 (Volume 37, Issue 4)

EXECUTIVE DIRECTOR’S MESSAGE

Susan P. Landis, Executive Director of ACRP

 

 

 

 

Perhaps you are familiar with the old saying about how “life is what happens when you’re busy making other plans.” In our field, the corollary could be that “decentralized clinical trials (DCTs) are what happen while the industry is busy clarifying guidance for them.”

In the “necessity is the mother of invention” atmosphere of the pandemic’s early days, DCTs rapidly went from being a “nice to have” type of arrow in one’s clinical trials quiver to a “need to have” one. Regulators appreciated that sponsors and trial sites were scrambling to adjust to the new normal of hybrid and fully decentralized trials and were generally flexible and encouraging about allowing professionals to manage those studies in the most expedient and safe manners possible under the circumstances. Now that the health crisis has calmed down considerably, these same regulators are nailing down guidance for how DCTs should be implemented—while industry simultaneously demands that sites and study teams incorporate them.

The lived experience in the clinical research enterprise is that DCTs, as they are widely being used today, fall somewhere between the hope and the hype that surrounded them back in early 2020. They morphed from being a framework for study conduct (not so dissimilar from the adoption of “pragmatic trials”) that was already using some decentralized components, however infrequently, to one that matured so rapidly, it outraced the ability of regulators to keep up.

To steal from another wise adage—the one about “the train has already left the station”—if you are going to clarify regulatory guidance for DCTs while they are being conducted, then you better ask the conductors (in this case, the sites and clinical research professionals actually implementing the decentralized components) about what needs to be clarified for the benefit of accelerating adoption and, thus, greater access for everyone to potentially life-changing clinical research trials. Which is to say (in an opinion I know is shared by others who have the subject matter expertise to be taken seriously on the topic) that trial sites themselves need to have the loudest voice and the most input on how DCTs can and should continue to be improved upon and executed.

Simply put, I know this to be true: the burden of the adoption of DCTs falls to the sites. That means that we have to listen to site leaders and their study teams about their experiences in order to get it right. That’s what ACRP has been doing.

Among other activities, your Association has striven to stay on top of the evolving situation by publishing blogs with timely commentary and offering webinars from subject matter experts on the DCT topic going back at least to early 2020, publishing a white paper with perspectives on DCTS for our profession in early 2022, launching an introductory course on DCTs last month, commenting on U.S. Food and Drug Administration draft guidance on DCTs earlier this month, and, soon, publishing a new white paper on “Overcoming Obstacles to Decentralized Clinical Trials: Unique Perspectives from Research Sites and Clinical Research Professionals.”

It was my happy privilege to be part of the writing team for this upcoming white paper, along with Mohammed Ali, Chief Domain Expert, Decentralized Clinical Care, Medable; Caroline Redeker, Senior Vice President, Corporate Development, Advanced Clinical; Sarah Gillespie, Associate Director, DCTs, Syneos Health; and C. Jill Dawson, Consultant to the Association of Clinical Research Professionals.

What follows is just a taste of the full white paper. I welcome your feedback on what it has to say, because learning from one another is one of the things that makes this industry great.

Introduction to the White Paper

Use of decentralized clinical trial (DCT) elements accelerated sharply during the COVID-19 pandemic, enabling many trials to continue when they would otherwise have been impossible. This experience has confirmed that DCT technologies can enable sponsors, sites, and principal investigators (PIs) to meet their obligations to protect patient safety and deliver high-quality data. DCT and hybrid trials support a patient-centered approach by reducing barriers to study participation such as transportation, logistics, and geographical location, helping to improve access for diverse and underrepresented populations.{1} However, despite this significant progress, barriers remain. The result is that many sites do not yet use DCT elements, and those who do seem to find them burdensome, including the inconveniences of multiple technology platforms, passwords, and sign-in procedures. Furthermore, there are concerns that the momentum gained may be lost without deliberate action by stakeholders to commit to using decentralized and hybrid trial components.

A think tank was convened by ACRP to discuss progress to date and document barriers to adopting DCT and hybrid components in clinical trials from the perspectives of sites and clinical research professionals. Titled “From Trepidation to Trust: Documenting the Realities of Hybrid and Decentralized Clinical Trials Adoption,” the think tank involved 42 participants from trial stakeholder groups. Discussions at the think tank helped crystallize the viewpoints from a full range of clinical research professionals about strategies and solutions to overcome barriers and accelerate adoption of DCTs. This paper presents these viewpoints and proposed solutions.

For the purposes of the think tank, DCTs were defined as “studies executed through telemedicine and mobile/local healthcare providers, direct-to-patient shipments, and using processes and technologies differing from the traditional clinical trial model only at the site.”

Barriers to Success

Based on an online poll during the think tank, participants identified the top barriers to implementation of DCT elements as:

• The need for clarity from regulatory bodies, including addressing the role of PI oversight
• The importance of addressing budget issues
• The need to define responsibilities and accountability for managing third-party vendors
• The necessity to allow time and budget to train site staff on process and change management

Potential solutions to these barriers are discussed in the full white paper.

Stay Tuned

We conclude that DCT technologies—especially as part of a hybrid approach—can improve the patient experience, reduce the burden of trial participation, and enable remote interactions and data-gathering. They offer increased access to varied and underserved populations, helping boost the diversity of trial participants. Much recent progress has been made, including from a regulatory perspective, and in the emergence of vendors with groundbreaking new DCT technologies.

However, the multitude of challenges discussed at the think tank account for the fact that today, rather than saving time or money at site level, DCTs in fact increase the site burden. This happens in part because the use of trial-related technologies is complex and because, despite positive experiences during the pandemic, concerns remain about the rigor, reliability, and reproducibility of findings from DCTs compared to traditional, site-based trials. Without additional training, the clinical research workforce may not be sufficiently familiar with DCTs to handle their novel data flows, designs, and possibly statistical analyses. Further, fully validating the DCT model will require overcoming challenges related to sharing data across the industry.

Foundational to the future of DCTs will be regulatory clarity and solid evidence that these trials truly make a difference. With these in hand, trial stakeholders can look forward to improvements in the widely shared goals of improved diversity, engagement, and retention.

Intrigued? Keep watching the ACRP announcements on our website and in our e-newsletter and social media for word about when this valuable resource will be available for download.

Reference

1. Johnson O, Anderson Foster D, Bhagat R, Gunn NT, Hill M, Moultrie A, Sabo A, Starling R. 2023. Association of Clinical Research Professionals’ Response to FDA Draft Guidance on Diversity in Clinical Trials: Increased Diversity Should Be a Requirement, Not a Suggestion. Food and Drug Law Institute Update (Spring Edition). https://www.fdli.org/2023/01/association-of-clinical-research-professionals-response-to-fda-draft-guidance-on-diversity-in-clinical-trials/

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