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The Three Ds of DCTs
How design, data and delivery enhance the patient experience.
Jun 29, 2022
The pandemic proved that decentralized clinical trials (DCTs) can reduce patient burden while delivering quality data in a streamlined environment. Yet sponsors are still uncertain about how to design a DCT to ensure efficient performance delivery.
To tackle some of these uncertainties, IQVIA brought together industry experts and hosted a panel discussion. During the session titled Transforming the Decentralized Trial Model Through Design, Data and Delivery, Ryan Jones, CEO of Florence Healthcare; Zoltan Varga, IQVIA’s Head of Patient Recruitment & Enablement at IQVIA, Nicole Zandy, Senior Director for IQVIA Biotech, Katy Preciado, Director of Decentralized Clinical Trials at IQVIA and moderated by Patricia Salter, Head of DCT Global Operations at IQVIA shared best practices for planning and deploying DCTs that create a positive experience for patients, sites and sponsors. Here’s what they had to say.
What patients want
Planning a successful DCT doesn’t start with technology selection. To make a DCT truly patient centric, sponsors first must understand who their patients are, and what they expect from a trial experience. That is done by creating a detailed patient persona that defines where patients are in their disease journey, their relevant demographics and preferences, and any details that might motivate them to join a trial.
Along with exploring how open they are to using DCT technologies and home health visits as part of the trial experience, it’s important to determine what would make the trial – and access to a novel treatment – a more enticing proposition for patients. For example, if the treatment will address an unmet need, or improve on the current treatment experience, that may make the experience more appealing. Another example would be knowing whether the medication is available to the patient after the trial, or if they are expected to wash it out of their system, could determine their interest in trial participation.
Incentives for participation, or the opportunity to help others with their same condition can also be a value proposition that resonate with different patient groups.
Understanding patient motivators can help sponsors create more patient centric trials, as well as hone recruiting efforts and outreach campaigns. This is especially important in studies of novel treatments where there are limited patient populations.
Sponsors can use healthcare data and analytics modeling to define the patient persona, and to understand what will motivate them to participate in research. Hosting focus group conversations with sites and patients can also help trial planners identify preferences and determine how to best use technology to reduce the burden of participation without compromising safety and quality.
These insights will also shape recruiting strategies, helping sponsors craft messages that communicate the convenience and personalized care that DCTs offer. This is an important step to ensure patients understand the minimal travel and time burden required.
A recent survey conducted by IQVIA found that 74% of patients weren’t aware that telehealth, in-home care, and use of their own devices was even an option in clinical trials, yet 68% found these elements appealing. Promoting these benefits in patient outreach campaigns can help attract more participants to the screening process.
Site selection for DCTs
Once a trial is planned, sponsors need to think about their site selection process and criteria. One of the primary benefits of a DCT is the ability to reach more patients in more diverse communities that may not otherwise have access to clinical research. The reduced number of site visits, and use of the technology to create engagement makes participation possible, in even the most remote locales.
This allows sponsors to work with more sites beyond traditional hospitals and centers of excellence. However not every site is ready to embrace DCTs.
When vetting sites for a DCT, sponsors should look for teams that have a demonstrated comfort using technology in clinical trials, and pre-defined standard operation procedures (SOPs) that support remote work and remote monitoring. A track record of collaborating with other sites is also a good indication of readiness to work home health care providers, local labs, and other participants in a DCT network.
Once selected, the sponsor or CRO will need to provide training to all site staff on how to use the selected DCT technologies, how to capture data remotely, and how to work with external service providers as part of the trial process. DCTs are still new for many site teams, particularly if sponsors are choosing smaller or more remote sites that are less experienced hosting clinical trials. Ensuring staff have the training and support will be critical for success.
What’s your ‘Patient Zero’ plan?
As final step before recruiting begins, sponsors should test every element of the technology infrastructure via “patient zero exercises.” This dry run, which should be conducted in real world settings, can help sites and sponsors identify and fix technical glitches, like an app that won’t download or a lost telehealth connection, before patients are involved.
Industry experts agreed that a successful DCT design begins with patient feedback on what will deliver a positive trial experience. Talking to patients will ensure that sponsors choose technology that will enhance their experience within clinical research, and deliver value for everyone involved.
To hear the entire webinar on demand, visit Transforming the Decentralized Trial Model Through Design, Data and Delivery.