Evidence map›Paper›PMID 32557302›Full record

Trial reportTherapeutic innovation & regulatory science2020

Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.

Maria Apostolaros, David Babaian, Amy Corneli, Annemarie Forrest, Gerrit Hamre, Jan Hewett, Laura Podolsky, Vaishali Popat, Penny Randall

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Therapeutic innovation & regulatory science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 2 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

77 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Trial
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  5. 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
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  7. Trial
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  9. Trial
  10. Trial
  11. Article
  12. Review
  13. Article
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  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

17 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

9 authors.

Maria ApostolarosPharmaceutical Research and Manufacturers of America (PhRMA), 950 F Street NW, Suite 300, Washington, DC, 20004, USA.
David BabaianAdvarra Consulting, 1501 Fourth Ave, Suite 800, Seattle, WA, 98101, USA.
Amy CorneliClinical Trials Transformation Initiative, 200 Morris St, Durham, NC, 27701, USA.
Annemarie ForrestClinical Trials Transformation Initiative, 200 Morris St, Durham, NC, 27701, USA. annemarie.forrest@duke.edu.
Gerrit HamreHamre Strategies LLC, 507 N Elizabeth St, Durham, NC, 27701, USA.
Jan HewettOffice of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, New Hampshire Ave, Building 51, Silver Spring, MD, 20903, USA.
Laura PodolskyScience 37, Inc., 12121 Bluff Creek Dr, Suite 100, Los Angeles, CA, 90094, USA.
Vaishali PopatCenter for Drug Evaluation and Research, Office of New Drugs, Food and Drug Administration, New Hampshire Ave, Building 22, Silver Spring, MD, 20903, USA.
Penny RandallIQVIA, 10188 Telesis Court, Suite 400, San Diego, CA, 92121, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTraditional clinical trials are often expensive, inefficient, include selected populations, and can create significant participant burden via travel and other logistical demands. Using new technologies and methodologies to promote a decentralized approach has the potential to improve the efficiency of clinical trials. The Clinical Trials Transformation Initiative (CTTI)-a public-private partnership to improve clinical trials-launched a multi-stakeholder Decentralized Clinical Trials (DCTs) Project to provide recommendations on addressing the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States.

methodsInformed by qualitative group interviews and an expert meeting, CTTI engaged stakeholders to identify key challenges to implementing DCTs and possible solutions.

resultsThe CTTI DCT project team used the interview findings and expert feedback to develop recommendations that will drive broader use of DCTs.

conclusionsCTTI's recommendations cover protocol design, use of telemedicine and mobile healthcare providers, medical product supply chain, investigator delegation and oversight, and safety monitoring considerations. By implementing these recommendations, sponsors, contract research organizations, and others can help advance successful medical product development using mobile technologies and methodologies in DCTs.

Indexed as

Public-Private Sector PartnershipsResearch PersonnelHumansUnited StatesUnited States Food and Drug AdministrationMobile clinical trialsMobile medical applicationsMobile nursingMobile technologyParticipant-centric trialsTelehealth

Identifiers

PMID32557302
PMCPMC7362888

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.