Evidence map›Paper›PMID 36129129›Full record

ArticleClinical and translational science2022

Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality.

Katie F Maass, Matthew D Barfield, Mototsugu Ito, Christopher A James, Olga Kavetska, Marc Kozinn, Parag Kumar, Maureen Lepak, Luc Alexis Leuthold, Wenkui Li and 9 more

Abstract read
In one paragraph

Article in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
–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

28 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  17. Clinical evaluation of patterned dried plasma spot cards to support quantification of HIV viral load and reflexive genotyping.Proceedings of the National Academy of Sciences of the United States of America · 2025
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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

19 authors.

Katie F MaassGenentech, South San Francisco, California, USA.ORCID 0000-0002-0493-2863
Matthew D BarfieldRoche, Welwyn, UK.
Mototsugu ItoAstellas Pharma Global Development, Inc., Northbrook, Illinois, USA.
Christopher A JamesAmgen Research, Thousand Oaks, California, USA.ORCID 0000-0001-8749-0011
Olga KavetskaPfizer, Groton, Connecticut, USA.
Marc KozinnBristol Myers Squibb, Lawrenceville, New Jersey, USA.
Parag KumarGilead, Foster City, California, USA.
Maureen LepakSunovion, Marlborough, Massachusetts, USA.
Luc Alexis LeutholdNovartis, Basel, Switzerland.
Wenkui LiNovartis, Basel, Switzerland.
Dmitri MikhailovNovartis, Basel, Switzerland.
Shefali PatelJanssen R&D, Spring House, Pennsylvania, USA.ORCID 0000-0003-0362-6669
Nisha L PerezBlueprint Medicines, Cambridge, Massachusetts, USA.
Deanne Jackson RuddMerck & Co., Inc., Rahway, New Jersey, USA.
Blisse VakkalagaddaBristol Myers Squibb, Lawrenceville, New Jersey, USA.ORCID 0000-0002-8882-8771
Tracy M WilliamsEli Lilly and Company, Indianapolis, Indiana, USA.
Jiuhong ZhaAbbVie, North Chicago, Illinois, USA.
Xin ZhangEli Lilly and Company, Indianapolis, Indiana, USA.
Melanie D AndersonMerck & Co., Inc., Rahway, New Jersey, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Advances in the technologies to enable patient-centric sampling (PCS) have the potential to improve blood sample collection by enabling clinical trial participants to collect samples via self-collection or with the help of a caregiver in their home. Typically, blood samples to assess pharmacokinetics and pharmacodynamics of a drug during clinical development are collected at a clinical site via venous blood draw. In this position paper by the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), the potential value PCS can bring to patients, to the clinical datasets generated, and to clinical trial sponsors is discussed, along with considerations for program decision making, bioanalytical feasibility, operations, and regulatory implications. With an understanding of the value of PCS and considerations when implementing during clinical drug development, we can bring the promise of PCS closer to reality and enable decentralized clinical trials.

Indexed as

Drug DevelopmentPatient-Centered CareHumans

Identifiers

PMID36129129
PMCPMC9747123

What OpenQuestion holds

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Registered trials

None linked

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.