Evidence map›Paper›PMID 38216192›Full record

Trial reportBMJ open2024

Climate footprint of industry-sponsored clinical research: an analysis of a phase-1 randomised clinical study and discussion of opportunities to reduce its impact.

Jason Keith LaRoche, Rodrigo Alvarenga, Michael Collins, Thomas Costelloe, Wouter De Soete, Jeremy Faludi, Kristel Rens

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04208061 (A Phase 1, 2-Panel, Fixed-Sequence, Open-Label Single-Center Study to Assess the Effect of Single and Multiple Doses of Darunavir in Combination With Cobicistat or Ritonavir on the Pharmacokinetics of Single Dose Dabigatran Etexilate in Healthy Subjects), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 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.

NCT04208061 phase1completednot on this map

A Phase 1, 2-Panel, Fixed-Sequence, Open-Label Single-Center Study to Assess the Effect of Single and Multiple Doses of Darunavir in Combination With Cobicistat or Ritonavir on the Pharmacokinetics of Single Dose Dabigatran Etexilate in Healthy Subjects

TypeinterventionalSponsorJanssen Research & Development, LLCRan2019 to 2021Enrolled28ConditionsHealthyArmsDabigatran Etexilate, DRV/COBI, Ritonavir, Darunavir
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  5. Quantification and reduction of the health sector's environmental impact.Bulletin of the World Health Organization · 2026
    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

7 authors.

Jason Keith LaRocheJanssen Clinical Innovation, Janssen Research and Development LLC, Titusville, New Jersey, USA jlaroche@its.jnj.com.ORCID 0009-0002-3162-5735
Rodrigo AlvarengaEnvironmental Resources Management, Ghent, Belgium.
Michael CollinsProduct Sustainability, Environmental Resources Management, Edinburgh, UK.
Thomas CostelloeEnvironmental Resources Management, Bletchley, UK.
Wouter De SoeteJanssen Pharmaceutica NV, Beerse, Belgium.
Jeremy FaludiIndustrial Design Engineering, Delft University of Technology, Delft, The Netherlands.
Kristel RensJanssen Pharmaceutica NV, Beerse, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study aims to calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from all in-scope activities involved in a phase-1 clinical study.

designRetrospective analysis. DATA SOURCE: Internal data held by Janssen Pharmaceuticals. STUDIES INCLUDED: Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019 and 2021. MAIN OUTCOME: Measure CO

resultsThe CO

conclusionsDecentralised trial models which seek to bring clinical trial operations closer to the participant offer opportunities to reduce participant travel. The electrification of sponsor vehicle fleets and society's transition towards electric vehicles may result in further reductions. TRIAL REGISTRATION NUMBER: NCT04208061.

Indexed as

Carbon FootprintTransportationCarbon DioxideHumansRetrospective StudiesTravelCarbon DioxideClinical TrialClinical trialsHealth policy

Identifiers

PMID38216192
PMCPMC10806794

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.