Speakers from Sanofi and CMIC discussed their respective experiences with DCT in Europe and Japan during Informa Connect’s Decentralized Clinical Trials hybrid meeting, held June 6-8.
Decentralized clinical trials (DCTs) offer a way for patients to participate in clinical trials who may not have the opportunity otherwise. Designing and conducting such trials takes more than simply adding technology to existing studies, though, and organizations around the world are trying to determine exactly what is needed to make them successful.
Speakers from Sanofi and CMIC discussed their respective experiences with DCT in Europe and Japan during Informa Connect’s Decentralized Clinical Trials hybrid meeting, held June 6-8.
Sanofi, as part of the EU public-private partnership known as the Innovative Medicines Initiative (IMI), is nearly halfway through a pan-European, five-year study involving Trials@Home. “We’re looking at a deep dive analysis and are talking with all the stakeholders – patient reps, vendors, sponsors, sites, patients, etc. – to see what works and what doesn’t,” Kimberly Hawkins, head of global clinical project operations & dossiers delivery at Sanofi, USA told the audience.
In an early DCT study, Sanofi aimed to enroll 150 participants in a trial to compare outcomes between remote and traditional approaches to glycemic control with insulin glargine. Only 15 people enrolled, and the trial terminated early. There’s a lot to be learned from that.
“There were a lot of technical challenges,” Hawkins explained. Devices, including video conferencing, didn’t always work and there were data synchronization errors. That partially may have stemmed from the selection of unsuitable technologies or vendors who were not experienced with clinical trials. Consequently, ensuring the validity of home data collection was problematic.
She also noted that staff approached trial planning and regulatory procedures differently, based upon their specialty. “There were a lot of questions about how DCT would work and whether regulators would find the data acceptable, as well as questions about the process and patient privacy.”
That assessment, combined with case studies from the 32 companies in the IMI consortium, uncovered three imperatives. Trials must:
- Be simple and convenient
- Address key healthcare issues
- Focus on the patient experience
“If you have great technology but participants need to log into seven different portals, you won’t enable research,” Hawkins pointed out. She also recommended determining whether a trial is suitable for decentralization, because some populations or diseases may not be ready for decentralized components.
Later this year, Hawkins said Sanofi plans to launch a six-country pilot project to compare conventional recruitment with that of hybrid and fully decentralized study arms. Learnings will focus on patient retention, recruitment, diversity, cost and satisfaction among site personnel and patients. The project intends to measure variables related to data quality, safety oversight and treatment compliance to evaluate the acceptability of DCT approaches.
Dubbed RADIAL (Remote and Decentralized Innovative Approaches to Clinical Trials), the study will recruit patients with Type 2 diabetes who are not achieving adequate control with their previous treatments. Part A involves site-based recruitment and employs randomized conventional and hybrid arms. Part B is a fully remote arm with remote recruitment. It is scheduled to begin later in 2022.
In Japan, CMIC Co., Ltd. is laying the foundation for successful DCT trials. Because it is involved in nearly 80% of new drugs developed in Japan, it is well-placed to shape the future of DCTs there. Its 24 consolidated subsidiaries provide end-to-end support and include contract research, contract development and manufacturing, site support for medical institutions and their staff, healthcare solutions and market solutions. It is a member of the U.S.-based Decentralized Trials & Research Alliance.
CMIC’s particular strength is in early phase clinical trials, Shuji Ozawa, director of the future design division, said. Initially, “We rebuilt traditional workflow for the site around site initiation, data capture and walk-through, and established an efficient process to capture clinical data and outpatient data…thus shortening the (trial) timeline and reducing errors and costs by cutting paper-based operations.”
CMIC is applying those principles as it expands its platform to adopt hybrid and fully decentralized clinical trial models.
Using DCT in a trial to treat COVID-19 patients allowed them to participate from home through telemedicine for communications, wearable devices for 24/7 patient monitoring and home nursing for sample collection. When more personal medical attention was needed, Mobility-as-a-Service – a car with medical equipment – could be dispatched. Launched one year ago, this is a collaboration with the medical community and government to enable medical care for patients who find it difficult to travel to medical institutions for care.
Both Ozawa and Hawkins reported a need for education around DCT for all involved, including site and study coordinators, medical personnel and the patients themselves. Collaboration with the trial site and the technology provider also is important, Ozawa said.
With these examples, the future of clinical trials is poised for change. “Having completely decentralized clinical trials is not necessarily, however, the way forward,” Hawkins said, but it does provide valuable alternatives to traditional clinical trials. With that in mind, she added, “We should shift our thinking so we don’t build a study and shove DCT into it. Instead, think about what we really want to find out and what is really needed to do that.” Copying past protocols may not be the best approach.
What is becoming clear is that DCT isn’t an all-or-nothing option. If the goal is to make it easier for more patients to participate in clinical trials, sponsors must engage patients. That involves determining which aspects of a trial may be performed virtually and which should be conducted in person. Even reducing patient visits to healthcare centers by 15% or 25% can ease a significant part of the burden of participating in clinical trials, Hawkins pointed out.
