Evidence map›Paper›PMID 39810842›Full record

ArticleContemporary clinical trials communications2025

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, Tatiana Shablinski, Susan E Shoaf, Chris Chung, Michelle Bullock

Abstract read
In one paragraph

Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Chelsea YeVerily Life Sciences, 269 E Grand Ave., South San Francisco, CA, 94080, USA.
Tatiana ShablinskiVerily Life Sciences, 269 E Grand Ave., South San Francisco, CA, 94080, USA.
Susan E ShoafOtsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Dr, Princeton, NJ, 08540, USA.
Chris ChungOtsuka Pharmaceutical Development & Commercialization, Inc., 508 Carnegie Center Dr, Princeton, NJ, 08540, USA.
Michelle BullockVerily Life Sciences, 269 E Grand Ave., South San Francisco, CA, 94080, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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/m 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.

Indexed as

Alternative clinical trial designDecentralized clinical trialEvidence-based medicinePatient-centric clinical trialSelf-directed trial procedures

Identifiers

PMID39810842
PMCPMC11731279

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.