Evidence map›Paper›PMID 39219999›Full record

ReviewJournal of immunotherapy and precision oncology2024

Decentralized Clinical Trials in Early Drug Development-A Framework Proposal.

Diogo J Silva, Blessie Elizabeth Nelson, Jordi Rodon

Abstract readReview
In one paragraph

Review in Journal of immunotherapy and precision oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. The potential of artificial intelligence in clinical trials.European journal of clinical investigation · 2026
    Review
  2. Article
  3. 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

3 authors.

Diogo J SilvaLocal Health Unity of Matosinhos - Hospital Pedro Hispano, Matosinhos, Portugal.ORCID https://orcid.org/0000-0001-5295-6715
Blessie Elizabeth NelsonDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jordi RodonDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The COVID-19 pandemic has led to a rethinking of clinical trial design to maintain clinical research activity, with regulatory changes allowing for the wider implementation and development of decentralized design models. Evidence of the feasibility and benefits associated with a remote design comes mainly from observational studies or phase 2 and 3 clinical trials, in which implementation is easier with a better-established safety profile. Early drug development is a slow and expensive process in which accrual and safety are key aspects of success. Applying a decentralized model to phase 1 clinical trials could improve patient accrual by removing geographic barriers, improving patient population diversity, strengthening evidence for rare tumors, and reducing patients' financial and logistical burdens. However, safety monitoring, data quality, shipment, and administration of the investigational product are challenges to its implementation. Based on published data for decentralized clinical trials, we propose an exploratory framework of solutions to enable the conceptualization of a decentralized model for phase 1 clinical trials.

Indexed as

decentralized clinical trialsdrug developmentphase 1

Identifiers

PMID39219999
PMCPMC11361338

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.