Evidence map›Paper›PMID 37481202›Full record

ArticleContemporary clinical trials2023

"Click and mortar" opportunities for digitization and consumerism in trials.

Rachel L Randell, Christoph P Hornik, Lesley Curtis, Adrian F Hernandez, Tom Denwood, Camille Nebeker, Jeremy Sugarman, Benoit Tyl, Masahiro Murakami, Leslie Oley Wilberforce and 8 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

18 authors.

Rachel L RandellDuke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA. Electronic address: rachel.randell@duke.edu.
Christoph P HornikDuke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
Lesley CurtisDuke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
Adrian F HernandezDuke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
Tom DenwoodPopulation Health Partners LLPShort Hills, NJ, USA.
Camille NebekerHerbert Wertheim School of Public Health & Human Longevity Science, University of California San Diego, La Jolla, California, USA.
Jeremy SugarmanBerman Institute of Bioethics and Department of Medicine,Johns Hopkins University, Baltimore, MD, USA.
Benoit TylBayer Healthcare SAS, La Garenne Colombes, France.
Masahiro MurakamiEli Lilly & Company, Indianapolis, IN, USA.
Leslie Oley WilberforceEvidation, San Mateo, CA, USA.
Sherry PagotoDepartment of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.
Ola VedinBoehringer Ingelheim AB, Sweden.
Tomas AnderssonBio Pharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Olveen CarrasquilloDivision of General Internal Medicine Co-Director, Miami Clinical & Translational Science Institute (CTSI), University of Miami, Miami, FL, USA.
Rowena DolorDuke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
Scott H KollinsDuke University, School of Medicine, Durham, NC, USA; Akili, Inc, Boston, MA, USA.
Jill PellegrinoReal World Evidence, CVS Health, Woonsocket, RI, USA.
Megan L RanneySchool of Public Health, Yale University, New Haven, CT, USA.

Funding

UNC-Duke Collaborative Clinical Pharmacology Postdoctoral Training Program-Evaluation SupplementT32GM086330 · NIGMS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KIM L.R. BROUWER, Daniel Gonzalez · 2011 to 2026
$8.5M
Mentoring in mHealth and Social Networking Interventions for CVD Risk ReductionK24HL124366 · NHLBI · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI PAGOTO, SHERRY L. · 2015 to 2024
$1.1M
Duke-UNC Collaborative Pediatric Clinical Pharmacology Postdoctoral Training ProgramT32HD104576 · NICHD · DUKE UNIVERSITY · PI BROUWER, KIM L.R., GONZALEZ, DANIEL · 2021 to 2025
$962k
NHLBI NIH HHS K24 HL124366NICHD NIH HHS T32 HD104576NIGMS NIH HHS T32 GM086330
6 · The paper itself

Abstract

backgroundDigitization (using novel digital tools and strategies) and consumerism (taking a consumer-oriented approach) are increasingly commonplace in clinical trials, but the implications of these changes are not well described.

methodsWe assembled a group of trial experts from academia, industry, non-profit, and government to discuss implications of this changing trial landscape and provide guidance.

resultsDigitization and consumerism can increase the volume and diversity of trial participants and expedite recruitment. However, downstream bottlenecks, challenges with retention, and serious issues with equity, ethics, and security can result. A "click and mortar" approach, combining approaches from novel and traditional trials with the thoughtful use of technology, may optimally balance opportunities and challenges facing many trials.

conclusionWe offer expert guidance and three "click and mortar" approaches to digital, consumer-oriented trials. More guidance and research are needed to navigate the associated opportunities and challenges.

Indexed as

ConsumerismDecentralized trialsDigital trials

Identifiers

PMID37481202
PMCPMC10530120

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.