Evaluating the environmental impact of clinical research: a life-cycle analysis of a French academic randomised clinical trial

ObjectivesTo assess the environmental impact of an academic clinical trial, by adapting the life-cycle analysis methodology to clinical research. DesignA retrospective, simplified complete life-cycle analysis (LCA), according to the EF 3.0 methodology. LCA is a standardised (ISO14040/44) method for assessing the environmental impacts of a product over its entire life cycle on several environmental issues. It is the balance of inputs and releases associated with the process, from conception to end-of-life. SettingA prospective, double-blind, randomised controlled trial in neurosurgery. The trial included 202 patients in 18 university hospitals across France. ParticipantsNot applicable InterventionNot applicable Main outcome measuresFourteen impact indicators that could be combined into a single score, for the identification of hotspots of interest. ResultsClimate change (or greenhouse gas emissions), was the most important indicator, accounting for almost 30% of the single score. Greenhouse gas emissions were estimated at 31.6 tons of carbon dioxide equivalent. This was followed by the depletion of abiotic resources - fossil fuels (24%), resource use - minerals and metals (12%), and particulate matter emissions (8%). The main hotspots identified were patient transport and clinical research assistant travel for source data verification. ConclusionsBy using complete LCA approach, our study confirms that conducting a clinical trial has a significant environmental impact, particularly on climate change. The main identified hotspots were related to the transport of patients and clinical research assistants ARTICLE SUMMARYStrengths and limitations of this study - This study describes the first complete life-cycle analysis of a clinical trial - Fourteen environmental factors were assessed, appraising all trial activities, from conception to close-out - This study complements those previously published in the process of establishing eco-design as a new paradigm for clinical research - Only one clinical trial was assessed, limiting the transposability of the conclusions - Due to the lack of published impact data for some activities, assumptions had to be made to estimate their environmental impact