Evidence map›Paper›PMID 35513479›Full record

ReviewNPJ digital medicine2022

Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion.

Noah Goodson, Paul Wicks, Jayne Morgan, Leen Hashem, Sinéad Callinan, John Reites

Open access · goldAbstract readReview
In one paragraph

Review in NPJ digital medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 87 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 1 pooled it
24.5field-weighted citation impact, top 1% of its field
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

87 citing papers in PubMed, 1 synthesis or guideline pooled it, 132 citations in OpenAlex.

  1. Guideline
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  9. AI-based augmentation of oncology clinical trials.Nature reviews. Clinical oncology · 2026
    Review
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27 more citing papers are in PubMed but not listed here.

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

6 authors at 3 institutions in 2 countries.

Noah GoodsonTHREAD Research, 155 El Camino Real, Tustin, CA, 92780, USA. noah@threadresearch.com.ORCID http://orcid.org/0000-0002-1376-1541
Paul WicksWicks Digital Health, Advantage House, Lichfield, Staffordshire, WS13 6AQ, UK.ORCID http://orcid.org/0000-0002-2293-9284
Jayne MorganPiedmont Health, 2727 Paces Ferry Road SE Building 2, Suite 1100, Atlanta, GA, 30339, USA.
Leen HashemWicks Digital Health, Advantage House, Lichfield, Staffordshire, WS13 6AQ, UK.
Sinéad CallinanTHREAD Research, 155 El Camino Real, Tustin, CA, 92780, USA.ORCID http://orcid.org/0000-0001-6988-2548
John ReitesTHREAD Research, 155 El Camino Real, Tustin, CA, 92780, USA.
NHS Digital · GBBank of England · GBPiedmont HealthCare · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Traditional clinical trials have often failed to recruit representative participant populations. Just 5% of eligible patients participate in clinical research. Participants, particularly those from minority groups, cite geographical constraints, mistrust, miscommunication, and discrimination as barriers. Here, an intersectional view of inclusion in clinical trials provides significant insights into the complex and counterintuitive challenges of trial design and participant recruitment. The US FDA have recently proposed that decentralized clinical trials (DCTs) might reduce barriers and appeal to a wider range of participants by reducing the costs and commitments required for patients to participate. While common sense and early evidence suggests that allowing participants to take part in trials at or near home has advantages in terms of convenience, travel, and perhaps even infection control, it remains to be seen if DCT approaches will yield significant improvements on participant inclusivity. Some digital studies aiming to be more inclusive on a single element of inclusion, such as race, have experienced unintended consequences in other elements, like education or gender. Implementing DCTs presents new challenges including the digital divide, the exclusion of certain tests and procedures, complexities of at-home medication delivery, and the need to build new infrastructure. We present a range of challenges and opportunities for researchers to adopt and adapt DCT approaches to create reliable evidence that applies to all of us.

Identifiers

PMID35513479
PMCPMC9072305
OpenAlexW4229007952

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.