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

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          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 2e) for in-scope clinical trial activities calculated according to intergovernmental panel on climate change 2021 impact assessment methodology.

          Results

          The CO 2e 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.

          Related collections

          Most cited references24

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          Does telemedicine reduce the carbon footprint of healthcare? A systematic review

          In the rapidly progressing field of telemedicine, there is a multitude of evidence assessing the effectiveness and financial costs of telemedicine projects; however, there is very little assessing the environmental impact despite the increasing threat of the climate emergency. This report provides a systematic review of the evidence on the carbon footprint of telemedicine. The identified papers unanimously report that telemedicine does reduce the carbon footprint of healthcare, primarily by reduction in transport-associated emissions. The carbon footprint savings range between 0.70–372 kg CO 2 e per consultation. However, these values are highly context specific. The carbon emissions produced from the use of the telemedicine systems themselves were found to be very low in comparison to emissions saved from travel reductions. This could have wide implications in reducing the carbon footprint of healthcare services globally. In order for telemedicine services to be successfully implemented, further research is necessary to determine context-specific considerations and potential rebound effects.
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            At What Cost to Clinical Trial Enrollment? A Retrospective Study of Patient Travel Burden in Cancer Clinical Trials

            Several barriers to clinical trial participation exist; however, the burden of cost and time associated with travel to visits may contribute to disparities in care. This analysis may inform ways that health care payers and systems can reduce the burden to encourage equitable recruitment and retention in cancer clinical trials. Background. Recent literature suggests that living in a rural setting may be associated with adverse cancer outcomes. This study examines the burden of travel from home to cancer center for clinical trial (CT) enrollees. Materials and Methods. Patients from the University of California San Francisco Clinical Trial Management System database who enrolled in a cancer CT for a breast, genitourinary, or gastrointestinal malignancy between 1993 and 2014 were included. Cancer type, household zip code, race/ethnicity, phase of study, study sponsor, and year of signed consent were exported. Distance traveled from home to center was calculated using a GoogleMaps application programming interface. The relationships of distance with phase of CT, household income, and race/ethnicity were examined. Results. A total of 1,600 patients were enrolled in breast (55.8%), genitourinary (29.4%), or gastrointestinal (14.9%) cancer CTs. The overall median unidirectional distance traveled from home to study site was 25.8 miles (interquartile range [IQR] 11.5–75.3). Of the trial sponsors examined, principal investigator (56.4%), industry (22.2%), cooperative group (11.6%), and National Institutes of Health (NIH; 9.8%), the longest distance traveled was for NIH‐sponsored trials, with a median of 39.4 miles ( p  < .001). Phase I (8.4%) studies had the longest distance traveled, with a median of 41.2 miles (IQR 14.5–101.0 miles; p  = .001). White patients (83%) traveled longer compared with black patients (4.4%), with median distances of 29.9 and 13.9 miles, respectively ( p  < .001). Patients from lower‐income areas ( n  = 799) traveled longer distances compared with patients from higher‐income areas ( n  = 773; 58.3 vs. 17.8 miles, respectively; p  < .001). A multivariable linear model where log10 (distance) was the outcome and adjusting for the exported variables and income revealed that cancer type, year of consent, race/ethnicity, and income were significantly associated with distance traveled. Conclusion. This study found that the burden of travel is highest among patients enrolled in NIH‐sponsored trials, phase I studies, or living in low‐income areas. These data suggest that travel burden for cancer CT participants may be significant. Implications for Practice. This study is one of the first to measure travel distance for patients in cancer clinical trials using a real‐world GoogleMaps calculator. Out‐of‐pocket expenses such as travel are not typically covered by health care payers; therefore, patients may face considerable cost to attend each study visit. Using a single‐center clinical trials enrollment database, this study found that the burden of travel is highest for patients enrolled in National Institutes of Health‐sponsored trials and phase I studies, as well as for patients living in low‐income areas. Results suggest that a significant proportion of patients enrolled in clinical trials face a substantial travel burden.
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              Forecasting the trajectory of electric vehicle sales and the consequences for worldwide CO2 emissions

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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2024
                12 January 2024
                : 14
                : 1
                : e077129
                Affiliations
                [1 ]departmentJanssen Clinical Innovation , Ringgold_6808Janssen Research and Development LLC , Titusville, New Jersey, USA
                [2 ]departmentIndustrial Design Engineering , Ringgold_2860Delft University of Technology , Delft, The Netherlands
                [3 ]Ringgold_114015Environmental Resources Management , Ghent, Belgium
                [4 ]departmentProduct Sustainability , Ringgold_114015Environmental Resources Management , Edinburgh, UK
                [5 ]Ringgold_114015Environmental Resources Management , Bletchley, UK
                [6 ]Ringgold_50148Janssen Pharmaceutica NV , Beerse, Belgium
                Author notes
                [Correspondence to ] Dr Jason Keith LaRoche; jlaroche@ 123456its.jnj.com
                Author information
                http://orcid.org/0009-0002-3162-5735
                Article
                bmjopen-2023-077129
                10.1136/bmjopen-2023-077129
                10806794
                38216192
                6f319112-eb16-4528-8634-c31ed7b3d17f
                © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 05 July 2023
                : 20 December 2023
                Categories
                Global Health
                1506
                1699
                Original research
                Custom metadata
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                Medicine
                clinical trial,clinical trials,health policy
                Medicine
                clinical trial, clinical trials, health policy

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