Evidence map›Paper›PMID 39872102›Full record

ArticleFrontiers in public health2024

Decentralized clinical trials are better for the participants and for the planet: the case study of a double-blind randomized controlled trial in Singapore (PROMOTE study).

Lisa R Fries, Nadia Khaled, Ivan Viveros Santos, Elvira Suniega-Tolentino, Motshewa Sesing, Melissa P S Toh, Chui Yuen Yang, Shiao Yng Chan, Sara Colombo Mottaz

Abstract read
In one paragraph

Article in Frontiers in public health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
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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.

Lisa R FriesNestlé Institute of Health Sciences Nestlé Research, Société des Produits Nestlé SA, Beijing, China.
Nadia KhaledClinical Research Unit, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
Ivan Viveros SantosCIRAIG, Chemical Engineering Department, Polytechnique Montréal, Montreal, QC, Canada.
Elvira Suniega-TolentinoClinical Research Unit, Nestlé Research, Société des Produits Nestlé S.A., Singapore, Singapore.
Motshewa SesingClinical Research Unit, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
Melissa P S TohSingapore Institute for Clinical Sciences Agency for Science, Technology and Research, Singapore, Singapore.
Chui Yuen YangSingapore Institute for Clinical Sciences Agency for Science, Technology and Research, Singapore, Singapore.
Shiao Yng ChanSingapore Institute for Clinical Sciences Agency for Science, Technology and Research, Singapore, Singapore.
Sara Colombo MottazClinical Research Unit, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Novel technologies have enabled the decentralization of many aspects of clinical trials, but little research has been done on the impact of these changes on the participant experience, trial operations, or the environment. Methods: A fully decentralized clinical trial conducted in Singapore is used as a case study to evaluate the operational outcomes, environmental impact (via life cycle assessment), and participants experience (qualitative interviews) of the decentralized model compared to a traditional study with in-person visits. Results: The decentralized study achieved high participant retention rates (97%) and high completion rates for clinical data, even for biological samples. Participants found the decentralized model to be convenient and safe, especially during the pandemic. Moreover, the decentralized model was found to be more environmentally friendly and less detrimental to human health compared to traditional face-to-face clinical trials, primarily by reducing participants' use of cars for site visits. Discussion: While this study focused on the environmental impact, it is important to consider other factors such as participant safety, convenience, and data quality when evaluating the suitability of a decentralized clinical trial approach. Careful planning of data flow, database structure, and data protection measures is essential. This study contributes to improving the environmental footprint of clinical trials. Environmental sustainability should be among the factors that are evaluated when selecting trial models. Decentralized and hybrid clinical trials offer efficiency, effectiveness, and environmental benefits. Further research and adoption of these approaches are encouraged.

Indexed as

PoliticsRandomized Controlled Trials as TopicAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedSingaporedecentralized clinical trialenvironmental impactlife-cycle assessmentmaternal healthRCTresearch participant experience

Identifiers

PMID39872102
PMCPMC11769950

What OpenQuestion holds

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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.