Evidence map›Paper›PMID 38305983›Full record

ArticleTherapeutic innovation & regulatory science2025

Decentralized Clinical Trials in the Development of Drugs and Biological Products.

Ryan Robinson, Leonard Sacks

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. 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

2 authors.

Ryan RobinsonU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Medical Policy, Silver Spring, MD, USA. Ryan.Robinson1@fda.hhs.gov.
Leonard SacksU.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Medical Policy, Silver Spring, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Decentralized clinical trials (DCTs) are trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. FDA supports decentralization to improve participation in clinical trials. While there are benefits of DCTs, including convenience for participants, sponsors and investigators should be aware of potential challenges such as coordination of trial activities at locations other than traditional trial sites and supervision of delegated trial-activities performed remotely. Appropriate training, oversight, and up-front risk assessment and management will be key to implementing a DCT successfully.

Indexed as

Biological ProductsClinical Trials as TopicDrug DevelopmentHumansUnited StatesUnited States Food and Drug AdministrationBiological ProductsDecentralized clinical trialDigital health technologiesFDALocal health care providerRemote

Identifiers

PMID38305983
PMCPMC12579723

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.