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

Por: LaRoche · J. K. · Alvarenga · R. · Collins · M. · Costelloe · T. · De Soete · W. · Faludi · J. · Rens · K.
Objective

This 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.

Design

Retrospective analysis.

Data source

Internal data held by Janssen Pharmaceuticals.

Studies included

Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019 and 2021.

Main outcome

Measure CO2 equivalents (CO2e) for in-scope clinical trial activities calculated according to intergovernmental panel on climate change 2021 impact assessment methodology.

Results

The CO2e emissions generated by the trial were 17.65 tonnes. This is equivalent to the emissions generated by driving an average petrol-fueled family car 71 004 km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study participants generated the most emissions (5419 kg, 31% of overall emissions), followed by trial site utilities (2725 kg, 16% of overall emissions) and site staff travel (2560 kg, 15% of overall emissions). In total, the movement of people (participant travel, site staff travel and trial site staff travel) accounted for 8914 kg or 51% of overall trial emissions.

Conclusions

Decentralised 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.

Birth cohort study indicates the impact of COVID-19 pandemic on early child language development

Por: Alvarenga · P.

Commentary on: Byrne S, Sledge H, Franklin R, Boland F, Murray DM, Hourihane J; CORAL Study group. Social communication skill attainment in babies born during the COVID-19 pandemic: a birth cohort study. Arch Dis Child. 2023 Jan;108(1):20-24. doi: 10.1136/archdischild-2021-323441. Epub 2022 Oct 11.

Implications for practice and research

  • Future research must explore contexts of crisis and disaster to investigate whether delays in acquiring the pointing gesture and the first meaningful words would result in cascading impairments in language development in early childhood.

  • During crises and disasters, caregivers must be encouraged to enhance verbal responsiveness following infants’ communicative and exploratory behaviours.

  • Context

    Several studies conducted during the COVID-19 pandemic have indicated deficits in different domains of infant development. This study by Byrne and colleagues compared early developmental milestones in two infant cohorts: babies born at the onset of the COVID-19 pandemic and babies born between...

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