The shift to technology-driven trials and specialized care for study participants during the pandemic opened the industry’s eyes to the benefits of decentralized research models. A recent IQVIA studied 12 Decentralized Clinical Trials (DCTs) and found that sponsors captured time and cost savings at virtually every point in the DCT research journey compared to traditional trials.
The DCTs studied saw an average 78% reduction in time to first patient in, 54% reduction in protocol deviations, and a 26% reduction of non-enrolling trial sites, among other measurable benefits.
The analysis also shows that when sponsors planned for DCT models from the start they experienced more time and cost savings and greater patient engagement that studies that added these elements at the last minute.
The research proves that choosing a DCT model can add value across treatment categories and patient populations – and these decentralized studies aren’t going away. Currently, about one-third of active clinical trials that IQVIA supports incorporate one or more DCT technologies or service capabilities, and 10% are fully decentralized.
A related survey conducted by Industry Standard Research (ISR) in 2021 found 83% of sponsors said they expect to increase their use of DCTs in the next three years, and half expect the cost of running DCTs will drop below the cost of traditional trials by next year.
Dedicated to innovate clinical research
As the commitment to DCTs increase, several industry organizations are now focused on how to enhance their DCT trial designs so they can best meet the needs of patients, sites and sponsors in every studies.
IQVIA hosted the recent webinar “Demonstrating the value of decentralized trial: What is in it for sponsors, sites and study participants” to explore how the insights and best practices these industry leaders have gathered. The conversation included Karen Noonan, SVP of global regulatory policy at the Association of Clinical Research Organizations (ACRO) and David Vulcano VP of Research Compliance & Integrity for HCA Healthcare, and honorary president of the Society Of Clinical Research Sites (SCRS); moderated by Bhausaheb Patil, Head of Business Operations, Decentralized Clinical Trials Solutions at IQVIA
Here is what they had to say.
ACRO builds a toolbox
Karen Noonan spent the last two years helping ACRO’s DCT Working Party develop a set of quality-based principles and tools to facilitate study implementations. To help advance DCTs, ACRO created the DCT toolkit which lays out a vision for how decentralized clinical trials can be planned and executed now and in the future. You can find more out about ACRO’s DCT toolkit here.
She shared four key takeaways the team learned through their research.
- DCTs will be different for every trial. The committee identified eight categories of DCT elements that include technologies and strategies to support every phase of a study. “Any clinical trial could contain one to eight of them,” Noonan said.
- Distinguish between planned versus an unplanned DCTs. “The promise and potential of a DCT is only fully realized if it’s planned, because you can use key tools, such as early engagement, across all stakeholders,” she said. It also makes it possible to follow a risk-based quality by design framework, which allows sponsors to develop robust protocols that align with study goals.
- Make sure DCT solutions don’t lead to new problems. Sponsors can be so eager to adopt technologies it can introduce unexpected challenges, like devices that are hard to use, investigators being treated like a help desk, and lack of planning to monitor home health visits. She encourages sponsors to vet every choice with investigators and patients, to be sure they add value without creating added complexities.
- Flexibility is the key to patient centricity. DCT solutions must be appropriate to the trial design and therapeutic area, but they also need to be “patient-appropriate,” she said. That includes giving patients choices where possible. For example, some patients might prefer site visits while others want telehealth; and some may want to use their own devices for study participation while others want a commissioned device. “It’s easy to think in binary terms when in reality there is a flexible continuum,” she says. “That takes early stakeholder engagement planning design.”
SCRS members open to DCTs
Founded in 2012, the Society for Clinical Research Sites (SCRS) mission is to unify the voice of the global research site community for greater site sustainability.
“Sites are in for this future,” David Vulcano states. Through an annually conducted SCRS site landscape survey, the 9,500-member organization shared that 66% of trials sites were approached to run a DCT in 2020 and 2021, and of that, 80% accepted the challenge. “Their top reasons were to bring their sites into the future, and to benefit their patient populations. Those who declined the opportunities, were most likely to say they were uncomfortable with the delegation of authority, especially when having mobile health professionals work on their behalf, notes Vulcano.
Though their early experiences with DCTs were not all stellar.
Only seven percent of the sites who led these trials felt that they were adequately compensated to handle the decentralized components. They pointed to many unexpected costs, particularly around training, and technical challenges that emerge in these trials. Many site coordinators said they were expected to train the study participants on trial technology, and to function as help desk support for patients and home health staff. “They just don’t feel ready, capable and adequately compensated to be able to be that help desk,” Vulcano said. They also felt they needed more help understanding how the DCT model addresses compliance around study oversight.
“They are interested as sites to be part of this future, and building the site experience around study participants,” he said. But they will need financial, technical and training support from sponsors and CROs to make them work.
Best practices from successful DCTs
Finally, IQVIA’s Patil offered advice garnered from the in-depth analysis his team conducted comparing conventional trials to DCTs.
- Make DCTs part of the plan from the beginning. The analysis found sponsors who planned for DCTs from the outset of the trial saw more consistent time and cost savings, and better patient experiences. “Look at every planning decision through the lens of the patient and their care team to determine how and where DCT elements could improve the trial experience,” he advises. “It is essential that the solution enhances the patient’s experience and reduces their burden while meeting all protocol requirements and fully adhering to safety and regulatory rules.”
- Consider technology investments and training as part of the trial plan. This includes planning for technology set-up and system integration before recruiting begins, delivering training to all staff and patients where needed, and providing ongoing maintenance throughout the trial.
- Develop effective communication and support strategies. This will ensure patients and sites have a trusted resource to help them troubleshoot the technology. “Keep a dialogue going and use the feedback to make refinements to your DCT model,” he says.
- Make sure every technology choice incorporates data privacy and protection regulations. These rules vary across regions, so the technology must be agile enough to adapt.
“DCT experiences captured during the pandemic can help the industry to identify the right digital strategies and better understand the patient journey,” Patil concludes. Using the lessons learned collected by ACRO and SCRS, and the best practices identified in IQVIA’s analysis will help industry leaders continue to enhance their DCT models and find the ideal balance of digital and human support for every study.
You can view the full webinar here to learn more about how ACRO and SCRS are supporting the evolution of DCTs.