Sustainable clinical trials:
Harnessing the power of clinical innovation to achieve net zero

ORIGINALLY PUBLISHED:
12 December 2023


Written by: Cristina Durán, President of Evinova; Natalie Fishburn, VP Clinical Operations, BioPharmaceuticals R&D, AstraZeneca; Michele Sample, VP, Late Stage Oncology Clinical Operations, AstraZeneca; Daniel ÖhmanSenior Section Director, BioPharmaceuticals R&D, AstraZeneca; Neil Mackillop, Senior Medical Director, BioPharmaceuticals R&D, AstraZeneca, Michael, Michael Collins, Partner, Product Sustainability & Circularity, ERM®


Clinical research is key to the development of new medicines. However, this process has the potential to generate up to 100 million tons of carbon dioxide equivalent emissions per year – similar to the yearly emissions of a country the size of Belgium.1 Through our commitment to sustainable science we’re innovating to reduce the environmental footprint of our clinical trials. In line with our Ambition Zero Carbon programme, we have set the target to decarbonise clinical trials on our road to net zero.

The climate crisis is one of the biggest health threats currently facing humanity. At the same time, approximately 5% of global greenhouse gas (GHG) emissions are generated within the healthcare sector, which means everyone involved in the delivery of healthcare has a role to play in driving sustainability and reducing emissions, while at the same time improving human health outcomes.2 Health and climate change are deeply interconnected.

Through a focus on continuous innovation in our clinical trials, we are pioneering new approaches and embedding sustainability into everything we do – from the lab to the patient. This means leveraging digital technologies and innovative processes to understand and reduce the environmental impact of clinical trials, while simultaneously improving access as well as the patient experience. 

Understanding our clinical trial emissions

In 2020, we conducted the world's first lifecycle analysis of a clinical trial to help us identify what drives the carbon footprint of clinical trials. In partnership with Environmental Resource Management (ERM) we undertook a GHG Life Cycle Assessment (LCA) to measure the carbon footprint of a Phase 3 heart failure trial. The following year, we expanded our assessment to quantify all GHG emissions sources in trials across our therapeutic areas.3

Identifying priority areas to decarbonise clinical trials

Our teams used this detailed analysis – linking specific trial activities and emissions – to identify ways to reduce or even eliminate emissions while still achieving trial purposes. This evidence formed the basis of our Roadmap to decarbonising clinical trials, which is one of the first step-by-step frameworks of its kind.

The roadmap identifies priority action areas to drive more sustainable clinical trials, including:

  • Optimising trial related travel, e.g. air travel
  • Consolidating lab kit supply and sample shipments 
  • Optimising patient visits and introducing hybrid approaches to trial activities
  • Managing investigational product waste
  • Impact of study devices

The roadmap provides Key Performance Indicators (KPIs) that address the drivers of emissions. These KPIs are being integrated into our clinical trial team objectives to shape trial planning and management. 

Sustainable clinical trials roadmap: action areas and metrics to monitor CO2


* Kits4Life is a cross-sector initiative, developed by the clinical research community to repurpose clinical trial supplies, lab kits, and equipment to close the healthcare gap worldwide.

** Science Based Targets initiative develops standards, tools and guidance which allow companies to set GHG emissions reductions targets in line with achieving net-zero by 2050 at latest.

The action areas identified are interconnected, meaning that changes in one area can have cascading effects on others. While these cascading effects can often lead to additional benefits, careful management is required to avoid burden-shifting i.e. passing carbon emissions from one activity or function to another.

Putting our roadmap into practice

Optimising sustainability through digital solutions

Before a clinical trial can begin, extensive research involving multiple site visits needs to take place to ensure site processes comply with Good Clinical Practice and that the relevant patient population will have access to the trial. To streamline this process, we are using advanced analytics to aggregate multiple data sets, helping us identify the right sites for our clinical trials and reducing the need for multiple site team assessment visits ahead of selecting a site.

Across our Oncology clinical trials, we are adopting a solution to seamlessly integrate data from electronic health records to the electronic data capture (EHR2EDC) which will streamline how we collect, manage and use clinical trial data. EHR2EDC has the potential to lower energy consumption by limiting redundant data entry and accelerate trial timelines by shortening the time needed for data processing. 

Unforeseen changes to the original clinical trial plan can also impact its footprint. Novel planning tools are helping us to address this, alongside tracking waste reduction targets as a measure of success, and continually highlighting the importance of early planning and communication across our clinical trial teams. 


By optimising the use of digital solutions and other innovations to lower emissions, teams used the Carbon Emission Index to calculate that a recent cardiovascular trial had 45% fewer GHG emissions (excluding drug manufacturing and supply) compared with similar studies using more traditional designs.


Study conduct: Clinical monitoring and management

Clinical trials currently ask a lot from patients and caregivers, with many appointments and measurements, which also impact the carbon footprint of trials. Technology can enable some of these assessments to be done at home. Prior to the COVID-19 pandemic, our teams had already begun seeking possible opportunities for operational adjustment; they reviewed 90 internal trial protocols and determined that collecting certain data at home could reduce visits by around 25% to 40% – which in turn could reduce emissions by an estimated 28%.

At-home digital solutions can be used to enable trial participants to capture clinically relevant events that could be part of composite trial endpoints. Composite endpoints combine two or more clinically relevant events into a single outcome variable that represents a valid measure of clinical benefit due to a given treatment. A recent study on chronic obstructive pulmonary disease (COPD) showed that using digital solutions and composite endpoints resulted in a trial design that required half the number of patients and half the required visits since more data could be collected over the course of the study compared with traditional COPD studies.  



25% reduction in our clinical trial CO2 emissions

Two years into our journey using the Carbon Emission Index in our Design and Study Planning system by Evinova, we have achieved a 25% carbon reduction for current trial designs across all therapeutic areas, calculated as CO2 per patient per year. We continue to be committed to following carbon reduction guidelines to decarbonise clinical trials and enable the delivery of our Ambition Zero Carbon targets

Driving engagement and external partnerships

Our roadmap highlights the importance of collaborating both internally – through creating a culture of sustainability and embedding the behaviours that will enable us to decarbonise our clinical trials – and externally, with commercial suppliers and external parties.

We estimate that implementing our Roadmap, together with climate action by external partners, can lead to a 74% reduction in our clinical trial emissions by 2030. We expect technological advances to enable us to address the remaining 26% of the carbon footprint, for example through clean heat. We will use high-quality nature-based solutions to address residual emissions from 2030 onwards.

Together with our industry peers in the public and private sectors, we are accelerating the delivery of net zero health systems through the Sustainable Markets Initiative (SMI) Health Systems Task Force. One key area of focus for the Task Force is digital solutions for sustainability in clinical trials. The Task Force white paper details the many ways digitalisation can support emissions reduction. In addition, members of the Task Force have come together to create the industry Low Carbon Clinical Trials project for commercial trials (iLCCT).

Beyond the Health Systems Task Force, we are also engaging with policymakers to integrate sustainability considerations into clinical trial frameworks and guidance, raising awareness of the links between clinical trial innovation and sustainability.



Join us: Working together to advance environmental sustainability in clinical trials

We know that our future depends on taking bold action for the health of people, society, and the planet. By pioneering sustainable science initiatives to lower clinical trial emissions, we are striving to lead by example and transform the delivery of healthcare.

We welcome committed, talented prospective employees to join us as we pioneer a science-led approach to lower the environmental impact of healthcare. By giving our people the resources and support to push the boundaries of science, we are going beyond the ordinary to help improve billions of lives worldwide.




Topics:



tags

  • Sustainability
  • Science

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References

1. Sustainable Healthcare Coalition, “Making Clinical Trials Sustainable” 2019. [Online]. Available: http://shcoalition.org/clinical-trials/ [Last accessed: July 2024].

2. Romanello M. et al. The report of the Lancet Countdown on health and climate change: health at the mercy of fossil fuels. Published online October 25, 2022, Available at: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01540-9/fulltext [Last accessed: July 2024].

3. Mackillop N, et al. Carbon footprint of industry-sponsored late-stage clinical trials. BMJ Open. 2023; 13(8).