Findings from a Phase I pharmacokinetic (PK) trial highlight the potential of decentralized clinical trials (DCTs) in remote data collection and monitoring. The study, published in Contemporary Clinical Trials Communications, emphasizes both the opportunities and challenges of conducting patient-centric clinical trials in decentralized settings. The research indicates that DCTs can improve patient access, representation, and enrollment, while also enhancing the speed and quality of data collection.
Decentralized Trials and Remote Data Collection
The COVID-19 pandemic underscored the importance of DCTs, as traditional site-based approaches faced significant disruptions. Remote, in-home collection of clinical trial data has gained widespread acceptance, with recent publications describing its incorporation into trial designs. Joel Morse, co-founder and CEO of Curavit Clinical Research, noted the need to realign processes to digital workflows to fully realize the potential of DCTs, emphasizing the importance of virtual sites as central hubs for trial activities and clinical data.
Phase I Trial Details
Researchers explored the operationalization of decentralized sample collection in a Phase I PK trial. The primary goal was to evaluate the feasibility of conducting remote trials involving at-home self-collection of PK samples, adhering to safety procedures consistent with traditional clinical trial settings. The Phase I, open-label, fixed-sequence trial was conducted at a single site in Walnut Creek, CA, enrolling 20 healthy adults aged 18 to 55 years with a body mass index from 19.0 to 32.0 kg/m2. The trial included a screening period, two clinic visits, two at-home visits, and a follow-up clinic visit.
Participants were administered a single, 100-mg oral dose of centanafadine sustained release at visits one, two, and four. PK samples, electrocardiograms (ECGs), and vital signs were gathered by trial personnel on visit one, under staff supervision for visit two, and remotely for visit four. A survey was also conducted to evaluate the utility of training, devices, and the Verily app, along with the ability to complete trial procedures.
Results and Patient Feedback
The results indicated that the Verily platform and procedures led to the successful collection of remote vital signs in at least 75% of participants, ECGs in at least 80%, and blood microsamples in between 65% and 70% of participants at visit four. The survey revealed that 95% to 100% of participants found the training adequate, enabling them to complete trial procedures independently. Participants favored self-collection over staff collection and expressed a willingness to participate in similar future research efforts.
Patient Insights into Decentralization
To understand more about the potential for clinical trial decentralisation, a team from Chiesi Farmaceutici recently initiated a study which aimed to understand the perspective of patients with asthma towards the use of clinical trial decentralisation, finding out more about the complexity of the patient journey, while obtaining and comprehensive patient feedback related to easing their burden, supporting their participation, and completing study requirements.
The team conducted semi-structured interviews in a diverse group of patients with moderate-to-severe and uncontrolled asthma in Argentina, Germany, Poland, and South Korea. The decentralised elements discussed included e-Consent, home spirometry, e-Diary and telemedicine.
Challenges and Future Directions
Investigators emphasized the need to balance factors such as participant type, surveillance intensity, and adequate training to minimize safety risks. Future remote PK studies should incorporate design considerations specific to this approach, including statistical plans that account for missing data and alternatives for participants unable to perform complex procedures at home. Diego Ardigò, Head of Global Research and Development at Chiesi, noted that while implementing DCTs can be complex, the benefits for patients are significant, and more decentralized approaches will likely be adopted across clinical trials.
