DOI: 10.5061/dryad.12jm63z3q
title: Climate footprint of industry-sponsored clinical research: An analysis of a phase-1 randomized clinical study and discussion of opportunities to reduce its impact

description: 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.
description: Lifecycle assessment performed according to ISO 14044 standards
 and peer reviewed by a third party.
description: # Climate Footprint of Industry-Sponsored Clinical Research:An Analysis of
 a Phase-1 Randomized Clinical Study and Discussion of Opportunities to
 Reduce Its Impact Dataset includes foreground data collected for the
 following elements of the clinical trial: * Information tab: General
 information over the file * Patient journey & nutrition tab:
 Foreground data on patient travel to and from the clinical site as well as
 meals served to patients during the in-patient care phase of the clinical
 study * Drug product tab: Foreground data for the drug product
 manufactureprocessing of laboratory samples (Samples) * Testing kits &
 consumables tab: Foreground data on the testing kits & consumables
 used at the clinical site * Samples tab: Foreground data on the processing
 of laboratory samples * Utilities commutes & meetings tab: Foreground
 data on the utilities used at trial site impacts and clinical trial
 management, commutes at trial site, J&J facilities and ethics
 committee * Background data tab: The aforementioned foreground data are
 required to be linked to background data in order to create a complete
 life cycle inventory. In this tab, the background data used (from
 Ecoinvent v3.8 and Agribalyse 3.0 LCI databases) is detailed, by life
 cycle stage, including the name of the process used in the database and
 regional & temporal data of the used data-set. Dataset
 “Results_tables” contains the tables provided in the document, i.e.,
 tables 4.1 and 4.2, but in an excel format. They represent the output of
 the LCA into two impact categories, i.e., climate change and cumulative
 exergy extraction from the natural environment (CEENE). The results are
 all normalized to the functional unit of the study, i.e., one full
 clinical trial. The LCA model was created using SimaPro version 9.3
 software system for life cycle engineering. ## Description of the Data and
 file structure The foreground and background data is grouped by element of
 the clinical trial and structured in separate tabs for each group.  Data
 is organized in tabular format.  Regarding the background data, for each
 unit (used to extend the foreground data into life cycle perspective),
 additional information is provided, i.e., the source, whether Ecoinvent
 v3.8 and Agribalyse 3.0 LCI databases, is noted as well as it’s reference
 year, geography, source, and proxy (if relevant). ## **Sharing/access
 Information** Links to other publicly accessible locations of the data:
 N/A ## **Was data derived from another source?** If yes, list source(s):
 Background data was sourced from the Ecoinvent v3.8 and Agribalyse 3.0 LCI
 databases