Decentralized Phase I Trial Highlights Promise of Remote Data Collection to Improve Clinical Research

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Findings from a Phase I pharmacokinetic (PK) trial show the promise of a decentralized approach in remote data collection and monitoring, which the authors said emphasizes the opportunities and difficulties of conducting decentralized patient-centric clinical trials.¹

The authors of the study, published by Contemporary Clinical Trials Communications, stated that facilitating access to effective therapies and removing the hurdles that prevent patients from participating in clinical trials will have a long-term positive impact on research and development, while also improving medication efficacy and patient outcomes. They noted that traditional clinical trial designs are effective in establishing the safety and efficacy of novel therapies, but are lengthy and carry a high cost, along with high failure rates because of challenges in patient recruitment. As such, stakeholders continue to explore methods to improve the process of gathering clinical data, with improved technology platforms that can leverage these data to enhance the breadth of clinical research.

“This has unlocked study modalities complementary to traditional clinical trials. One of these avenues is modernizing and boosting the agility of clinical studies, specifically by enabling the shift of trial operations to decentralized settings,” the study authors wrote. “This diversification became even more relevant as the COVID-19 pandemic began, and its protracted course has further galvanized efforts supporting decentralized, patient-centric research, as many ongoing clinical trials struggled with site-based approaches during general quarantines and lockdowns. As such, the remote, in-home collection of clinical trial data, in lieu of traditional site-based assessments, is gaining widespread acceptance, as evidenced by recent publications describing the incorporation of remote data collection into trial designs.”¹

Decentralized clinical trials (DCTs) are not a new trend in the clinical trial space, but the importance of developing DCTs was highlighted during the COVID-19 pandemic. The promise of DCTs lies in improving patient access, representation, and enrollment, as well as the speed in which trials are conducted and the quality of the data collected.

“We now have a deeper understanding and are learning from early mistakes. To fully realize the potential of DCTs, we must realign processes to digital workflows,” Joel Morse, Curavit Clinical Research co-founder and CEO, wrote in an article published by Applied Clinical Trials.² “This includes supporting the collection of comprehensive data sets, optimizing recruitment of the target patient populations, and leveraging both virtual and physical sites. This holistic approach to trial design will drive the next evolution of clinical trials. DCT 3.0, focused on digital-first principles, is poised to meet the original expectations. DCT 3.0 will be grounded in purpose-built virtual sites, which will serve as the central hub for trial activities and clinical data, coordinating the entire trial.”

For the current trial, researchers explored the use of operationalizing decentralized sample collection in a Phase I PK trial. Their primary goal was to evaluate the feasibility of conducting remote trials involving at-home self-collection of PK samples using safety procedures that are consistent with those used within a traditional clinical trial setting.

Investigators conducted the Phase I, open-label, fixed-sequence trial at a single site in the Diablo Clinical Research, in Walnut Creek, CA, enrolling healthy adults from 18 to 55 years of age with a body mass index from 19.0 to 32.0 kg/m². The trial involved a screening period, two clinic visits, two at-home visits, and a follow-up clinic visit.

A total of 20 individuals were enrolled in the trial with a mean age of 35.9 years. Patients 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, conducted under staff supervision for visit two, and conducted remotely for visit four. The study authors also performed a survey to evaluate the utility of training, devices, and the Verily app, along with ability to complete trial procedures.

The results show 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 found that between 95% and 100% of participants found the training to be adequate, allowing them to complete trial procedures on an individual basis. These participants indicated that they favored self-collection over staff collection, having visits in their own location, and that they would consider participating in similar future research efforts.

Investigators stated that their findings show the potential of a decentralized approach in conducting procedures in a Phase 1 PK trial.

“Ideally, decentralized, patient-centric trial designs will allow studies to balance factors, including the type of participants, intensiveness of surveillance, and adequate training, to minimize safety risks for participants,” the study authors wrote. “Future remote PK studies will need to incorporate design considerations particular to this approach, such as statistical plans that account for missing data when patients are unable to self-collect data and providing alternatives for participants who are unable to learn or perform complex procedures at home.”¹

References

Ye C, Shablinski T, Shoaf SE, Chung C, Bullock M. Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals. Contemp Clin Trials Commun. 2024 Nov 24;43:101396. doi: 10.1016/j.conctc.2024.101396. PMID: 39810842; PMCID: PMC11731279.

2. Staff report. Decentralized Clinical Trials: Bust or Breakthrough? Applied Clinical Trials. Web article. Published August 15, 2024. Accessed January 22, 2025. https://www.appliedclinicaltrialsonline.com/view/decentralized-clinical-trials-bust-or-breakthrough-