How clinical innovation is helping to reduce the environmental impact of clinical trials

Written by:

Cristina Durán

President of Evinova

Natalie Fishburn

VP Clinical Operations, BioPharmaceuticals R&D, AstraZeneca

Michele Sample

VP Clinical Operations, Oncology R&D, AstraZeneca

Clinical research is key to unlocking new medicines with potential to transform outcomes across many diseases. However, this process has 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 We are using a science-led approach to lower the environmental impact of healthcare and reduce greenhouse gas emissions by running our clinical trials sustainably to create a healthy future for society and the planet.

The climate crisis is one of the biggest health threats currently facing humanity. Climate change has the potential to negatively impact health outcomes, including exacerbating the prevalence of cardiovascular and respiratory illnesses and placing additional burden on health systems already under pressure.2 At the same time, currently 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 in driving sustainability and reducing emissions, while improving health outcomes.3

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

To accomplish this, we are committed to transparent reporting and measurement of our environmental footprint. For example, we were the first pharmaceutical company to utilise a Carbon Emission Index, a GHG reduction tool for trial teams to evaluate the predicted environmental footprint of a trial. This tool is a required part of study design and helps study teams calculate and optimise trial GHG emissions, keeping the environmental impact front of mind during trial design.


By optimising 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.


Going forward, we are using a multitude of such operational and digital health solutions throughout the clinical trial process – from study design to data analysis – to help lessen the environmental impact of our future trials.

Early clinical research planning

Before a clinical trial can begin, key stakeholders including site teams, researchers, and healthcare professionals must agree upon an appropriate number of sites to run the trial. This can require extensive research involving multiple site visits 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 and reduce our environmental footprint, 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.

When we are planning our clinical trials, we and our partners consider:

  • Which countries and sites will participate?
  • How can we ensure a diverse representation of the target patient population?
  • How quickly will patients be able to enrol in the study?

Currently, a significant amount of resources can be wasted due to unforseen changes to the original clinical trial plan, combined with a lack of timely visibility of the necessary amendments. To address this, we are using novel planning tools, tracking waste reduction targets as a measure of success, and continually highlighting the importance of early planning and communication across our clinical trial teams. 
 

Digital solutions for clinical monitoring and management

Importantly, we know that we don’t always have all the answers. After listening to patients, caregivers and trial investigators and reviewing our existing trial protocols, we gathered more than 14,000 comments about people’s experiences in clinical trials. The feedback clearly showed that clinical trials currently ask a lot from patients and caregivers, with many appointments and measurements – they questioned whether technology could support having some of these assessments at home. Even 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 GHG emissions by an estimated 28%.

At-home digital solutions can also 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. 
 


The importance of partnering for success

From operational changes to addressing how we design and deliver clinical trials, we are making great strides in reducing our GHG emissions. By collaborating with external partners, we have the potential to make even more progress.

That’s why Pascal Soriot, Chief Executive Officer, AstraZeneca convened the Sustainable Markets Initiative (SMI) Health Systems Task Force. This Task Force enables collaboration across the healthcare sector to accelerate the transition to net-zero health systems, including decarbonising clinical trials and patient care, leveraging the power of digital and innovation, as well as tackling scope 3 supply chain emissions. Cross-industry partnerships such as this will not only propel us closer to our Ambition Zero Carbon targets over the next decade, but they also encourage us to work together to be certain that our contribution to society respects our environment and ensures the sustainable use of the planet’s finite natural resources.

Because clinical trials touch so many aspects of the broader health system (including healthcare facilities, staff and patient travel, medicines manufacturing and delivery), examining how digitalisation reduces emissions in clinical trials shows vast potential for the use of digital technologies in the broader healthcare system.


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. At AstraZeneca, sustainability is part of our DNA, embedded in everything we do, from the lab to the patient. 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.

We welcome committed, talented prospective employees to join us as we pioneer a science-led approach to lower the environmental impact of healthcare and reduce GHG emissions the aim to create a healthy future for society and the planet.


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References

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

2.  World Health Organization, “Climate change and health,” 30 October 2021. [Online]. Available: http://www.who.int/news-room/factsheets/detail/climate-change-and-health.  

3.  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: January 2023].

 

Veeva ID: Z4-60423 
Date of preparation: December 2023