Research Article: Climate footprint of industry-sponsored clinical research: an analysis of a phase-1 randomised clinical study and discussion of opportunities to reduce its impact
Abstract:
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 CO 2 equivalents (CO 2 e) for in-scope clinical trial activities calculated according to intergovernmental panel on climate change 2021 impact assessment methodology. Results The CO 2 e 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 .
Introduction:
A phase-1 study represents the first testing of a new drug in humans primarily to assess safety. A drug is given to a small group of healthy volunteers who are then closely monitored. If the safety profile of the drug is favourable then it may advance to phase-2 where a small group of volunteers with the targeted disease are given the drug to further assess safety, understand how the drug is metabolised and begin to assess efficacy. If the safety and efficacy profile continue to prove favourable, then a drug may…
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