Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Nov 24:43:101396.
doi: 10.1016/j.conctc.2024.101396. eCollection 2025 Feb.

Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals

Chelsea Ye  1 , Tatiana Shablinski  1 , Susan E Shoaf  2 , Chris Chung  2 , Michelle Bullock  1
Affiliations

Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals

Chelsea Ye et al. Contemp Clin Trials Commun. .

Abstract

Background: The COVID-19 pandemic accelerated a shift to decentralized clinical trials. We present the potential feasibility of this approach from a phase 1 pharmacokinetic (PK) trial.

Methods: Healthy adults (18-55 years) with a body mass index of 19.0-32.0 kg/m2 were enrolled. The trial comprised a screening period, 2 clinic visits (visits 1, 2), 2 at-home visits (visits 3 and 4), and follow-up clinic visit (visit 5). Participants received a single 100-mg oral dose of centanafadine sustained release at visits 1, 2, and 4. Pharmacokinetic samples, electrocardiograms (ECGs; 6-lead [participant] and 12-lead [staff]), and vital signs were collected by clinical personnel (visit 1), under staff supervision (visit 2), and remotely (visit 4), facilitated by the Verily clinical trial application. Successful sample collection at visit 4 was reported descriptively. A survey assessed the utility of training, devices, and the Verily app, and ability to complete trial procedures.

Results: Among 20 participants enrolled, 90 % were female, mean (SD) age was 35.9 (11.1) years. Verily platform/procedures facilitated successful remote vital sign collection in at least 75 %, ECGs in at least 80 %, and blood microsamples in 65 %-70 % of participants at visit 4. Most agreed that training was adequate, and they were able to complete trial procedures on their own. Participants favored self-collection over staff collection, having visits in their own location, and would consider participation in similar future research.

Conclusions: Results from this decentralized PK trial, with remote, in-home sample collection and monitoring, demonstrated the potential feasibility of this study design.

Keywords: Alternative clinical trial design; Decentralized clinical trial; Evidence-based medicine; Patient-centric clinical trial; Self-directed trial procedures.

PubMed Disclaimer

Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Chelsea Ye, Tatiana Shablinski, and Michelle Bullock are employees of Verily Life Sciences, which received funding from 10.13039/100019120Otsuka for the clinical trial management platform used in this trial. Susan E. Shoaf and Chris Chung are employees of Otsuka Pharmaceutical Development & Commercialization, Inc.

Figures

Fig. 1
Fig. 1
Schematic of Trial Design. AE, adverse event; C-SSRS, Columbia-Suicide Severity Rating Scale; ECG, electrocardiograph; eDiary, electronic diary; ET, early termination; PK, pharmacokinetic; SR, sustained release.
See this image and copyright information in PMC

References

    1. Bernardez-Pereira S., Lopes R.D., Carrion M.J., Santucci E.V., Soares R.M., de Oliveira Abreu M., et al. Prevalence, characteristics, and predictors of early termination of cardiovascular clinical trials due to low recruitment: insights from the ClinicalTrials.gov registry. Am. Heart J. 2014;168(2):213–219.e211. doi: 10.1016/j.ahj.2014.04.013. - DOI - PubMed
    1. Zhang E., DuBois S.G. Early termination of oncology clinical trials in the United States. Cancer Med. 2023;12(5):5517–5525. doi: 10.1002/cam4.5385. - DOI - PMC - PubMed
    1. Walters S.J., Bonacho Dos Anjos Henriques-Cadby I., Bortolami O., Flight L., Hind D., Jacques R.M., et al. Recruitment and retention of participants in randomised controlled trials: a review of trials funded and published by the United Kingdom Health Technology Assessment Programme. BMJ Open. 2017;7(3) doi: 10.1136/bmjopen-2016-015276. - DOI - PMC - PubMed
    1. Fogel D.B. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemp. Clin. Trials Commun. 2018;11:156–164. doi: 10.1016/j.conctc.2018.08.001. - DOI - PMC - PubMed
    1. Khozin S., Coravos A. Decentralized trials in the age of real-world evidence and inclusivity in clinical investigations. Clin. Pharmacol. Ther. 2019;106(1):25–27. doi: 10.1002/cpt.1441. - DOI - PubMed

LinkOut - more resources