Climate footprint of industry-sponsored clinical research: An analysis of a phase-1 randomized clinical study and discussion of opportunities to reduce its impact
Data files
Jan 08, 2024 version files 65.90 KB
-
LCA_model.xlsx
48.80 KB
-
README.md
2.64 KB
-
Results_tables.xlsx
14.45 KB
Abstract
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.
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
Lifecycle assessment performed according to ISO 14044 standards and peer reviewed by a third party.