Evidence map›Paper›PMID 32821856›Full record

ReviewNPJ digital medicine2020

Digitizing clinical trials.

O T Inan, P Tenaerts, S A Prindiville, H R Reynolds, D S Dizon, K Cooper-Arnold, M Turakhia, M J Pletcher, K L Preston, H M Krumholz and 10 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in NPJ digital medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 199 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
199citing papers in PubMed, 6 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

199 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. Digitalized transcranial electrical stimulation: A consensus statement.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2022
    Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Mitigating fraud in a fully decentralized clinical trial of a digital health intervention.Annals of behavioral medicine : a publication of the Society of Behavioral Medicine · 2025
    Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Review
  19. Article
  20. Review

139 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

20 authors.

O T InanSchool of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA 30332 USA.
P TenaertsClinical Trials Transformation Initiative, Duke University, Durham, NC 27708 USA.
S A PrindivilleCoordinating Center for Clinical Trials, Office of the Director, National Cancer Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
H R ReynoldsSchool of Medicine, New York University, New York, NY 10003 USA.
D S DizonThe Lifespan Cancer Institute, Brown University, Providence, RI 02912 USA.
K Cooper-ArnoldNational, Heart, Lung and Blood Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
M TurakhiaVA Palo Alto Health Care System and the Center for Digital Health, Stanford University, Stanford, CA 94305 USA.
M J PletcherDepartment of Epidemiology and Biostatistics, University of California, San Francisco, CA 94143 USA.
K L PrestonIntramural Research Program of the National Institute on Drug Abuse at the National Institutes of Health, Baltimore, MD 21224 USA.
H M KrumholzThe Center for Outcomes Research, Yale New Haven Hospital, Yale University, New Haven, CT 06510 USA.ORCID 0000-0003-2046-127X
B M MarlinCollege of Information and Computer Sciences, University of Massachusetts at Amherst, Amherst, MA 01003 USA.ORCID 0000-0002-2626-3410
K D MandlComputational Health Informatics Program at Boston Children's Hospital, Departments of Biomedical Informatics and Pediatrics, Harvard Medical School, Boston, MA 02115 USA.ORCID 0000-0002-9781-0477
P KlasnjaSchool of Information, University of Michigan, Ann Arbor, MI 48109 USA.
B SpringNorthwestern University Feinberg School of Medicine, Chicago, IL 60611 USA.
E IturriagaNational Heart, Lung, and Blood Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
R CampoNational Heart, Lung, and Blood Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
P Desvigne-NickensNational Heart, Lung, and Blood Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
Y RosenbergNational Heart, Lung, and Blood Institute at the National Institutes of Health, Bethesda, MD 20892 USA.
S R SteinhublScripps Research Translational Institute, La Jolla, CA 92037 USA.ORCID 0000-0002-9256-7914
R M CaliffSchool of Medicine, Duke University, Durham, NC 27710 USA.

Funding

Scripps Translational Science InstituteUL1TR001114 · NCATS · SCRIPPS RESEARCH INSTITUTE, THE · PI TOPOL, ERIC JEFFREY · 2013 to 2017
$24.0M
NCATS NIH HHS UL1 TR001114
6 · The paper itself

Abstract

Clinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions. The concept of a "digital clinical trial" involves leveraging digital technology to improve participant access, engagement, trial-related measurements, and/or interventions, enable concealed randomized intervention allocation, and has the potential to transform clinical trials and to lower their cost. In April 2019, the US National Institutes of Health (NIH) and the National Science Foundation (NSF) held a workshop bringing together experts in clinical trials, digital technology, and digital analytics to discuss strategies to implement the use of digital technologies in clinical trials while considering potential challenges. This position paper builds on this workshop to describe the current state of the art for digital clinical trials including (1) defining and outlining the composition and elements of digital trials; (2) describing recruitment and retention using digital technology; (3) outlining data collection elements including mobile health, wearable technologies, application programming interfaces (APIs), digital transmission of data, and consideration of regulatory oversight and guidance for data security, privacy, and remotely provided informed consent; (4) elucidating digital analytics and data science approaches leveraging artificial intelligence and machine learning algorithms; and (5) setting future priorities and strategies that should be addressed to successfully harness digital methods and the myriad benefits of such technologies for clinical research.

Indexed as

Clinical trialsTranslational research

Identifiers

PMID32821856
PMCPMC7395804

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.