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

Objective: To calculate the global warming potential, in carbon dioxide (CO2) equivalent emissions, from a phase-1 clinical study Design: Retrospective analysis. Data source: Internal data held by Janssen Pharmaceuticals Studies included: Janssen-sponsored TMC114FD1HTX1002 study conducted between 2019-2021 Main outcome: measure CO2 equivalents for trial activities calculated according to IPCC 2021 impact assessment methodology Results: The CO2-eq emissions generated by the trial was 17.65 tonnes. This is equivalent to the emissions generated by driving the average petrol-fueled family car 71,004km or roughly 1.8 times around the circumference of the Earth. Commuting to the clinical site by the study patients generated the most emissions (5,419kg, 31% of overall emissions), followed by trial site utilities (2,725kg, 16% of overall emissions), and Janssen site staff travel (2,560kg, 15% of overall emissions). In total, the movement of people (patient travel, Janssen site staff travel, and trial site staff travel) accounted for 8,914kg or 51% of overall trial emissions. Conclusions: Opportunities exist to reduce many of the largest contributors to the clinical trial’s CO2-eq emissions. The largest contributor was patient travel (31%) and combined with sponsor (15%) and site staff (5%) travel, the movement of people was responsible for 51% of CO2-eq emissions. Decentralized trial models which seek to bring clinical trial operations closer to the patient offer opportunities to reduce patient travel. The electrification of sponsor vehicle fleets and society’s transition towards electric vehicles may result in further reductions.

Methods
Lifecycle assessment performed according to ISO 14044 standards and peer reviewed by a third party.