Sustainability: a new era in clinical trials

As the global focus on environmental, social, and governance (ESG) issues intensifies, the life sciences industry is emerging as a beacon of positive change. Amidst the challenges, there is palpable optimism as pharmaceutical companies and the international organisations and regulatory bodies that support them take a leadership role in sustainable innovation.

In a meeting in November 2023, representatives from over 40 countries participated in the World Health Organization’s first Global Clinical Trials Forum, where they discussed how to develop a joint vision to make clinical trials more sustainable¹. While these were just preliminary discussions and we're yet to see how initiatives will be implemented, they did discuss the importance of national funding for clinical trial infrastructure and the need for regulatory bodies across jurisdictions to coordinate to streamline the ethics review and approval process. Furthermore, the forum discussed the need to increase engagement with patients, the public, and other communities, likely in response to the misinformation issues surrounding COVID-19 and the approval process for the vaccine. Another key theme that arose post-COVID is the importance of the clinical trial process leaning into innovation, such as AI and greater digital management of data.  

In recent times, we've seen the EU make significant strides in enhancing the clinical research landscape through the Clinical Trials Regulation (CTR). This became effective in the beginning of 2022 and aimed at making the EU a more attractive and favorable destination for clinical research and again emphasized the need for transparency with the public. This regulation standardized processes for clinical trials across the EU, supported by the Clinical Trials Information System (CTIS), which allows sponsors to submit a single application and gain approval to run a trial in several European countries² and is another step in addressing sustainability concerns, through reducing the bureaucracy and lengthiness of the process.

The Accelerating Clinical Trials in the EU (ACT EU) initiative, launched by the European Medicines Agency (EMA), the European Commission (EC), and the Heads of Medicines Agencies (HMA), aimed to transform clinical trial initiation, design, and execution³. The ACT EU steering group established a multi-annual work plan for 2022-2026, focusing on 10 priority actions, including promoting innovation and establishing a multi-stakeholder platform, all with the aim of making trials more sustainable.

Furthermore, The Innovative Health Initiative, which is a partnership between the EU and various European industry associations (representing the pharmaceutical, medical technology, biotechnology, digital health, and vaccine industries⁴), was set up drive innovation in health research and provide funding for projects that address different areas of concerns, one of these being environmental impact⁵.

While this initiative was proposed at the beginning of 2021, it launched its first five projects in the summer of 2023⁶. By making funding accessible to clinical trials that can show they address environmental sustainability concerns, this will help make sponsors prioritize these areas to access this funding.

Another significant example of the collaborative efforts of the sector to address sustainability is the Pistoia Alliance. This alliance was launched in 2009 and has amassed over 200 members with representatives from many of the global pharmaceutical businesses. While the alliance itself is far from new, in 2022, it created the Clinical Trials Environmental Impact. One of the outputs of this collaboration is working toward a standard that companies can use to calculate the environmental impact of a clinical trial⁷ and enable them to compare the carbon footprint of site-based and decentralized clinical trials. While these parameters are yet to be finalized, it's another sign the industry is taking sustainability seriously.

Looking at the specific efforts of pharmaceutical companies, it is fair to say that they are in fact driving the change. One example of this is that most large pharma companies now have a chief sustainability officer (CSO) whose role is to implement technologies, operations, and policies in order to reduce company carbon footprints⁸. The creation of this role as part of the executive leadership team shows the commitment to put and keep sustainability on the board agenda.

Furthermore, many key players in the industry are committing themselves to ambitious pledges. For instance, a prominent CRO has emphasized considerations for climate change⁹ by committing to reducing emissions through technology utilization, virtual meetings, and remote patient monitoring, aligning with the industry's growing reliance on technology for sustainable trial conduct¹⁰.

In addition, a large global pharmaceutical company’s sustainability goals encompass environmental protection, ethics, and transparency. It set an ambitious goal to make clinical trial operations carbon-negative by 2030, marking a significant initiative in environmental sustainability¹¹. The company is integrating sustainability into clinical trials by using innovative processes and digital technologies, emphasizing the urgency of addressing the climate crisis and its potential impact on health outcomes¹². Examples include using at-home digital solutions to support participants, to reduce visits by 25% to 40% and significantly lower greenhouse gas emissions,¹³ and setting up a platform where CROs and other pharmaceutical companies can pay to access proven digital solutions to streamline how they run clinical trials,¹⁴ to name a few recent examples.

The industry's commitment to sustainability across the clinical trial supply chain is evident through the corporate social responsibility initiatives of key players. From exploring decentralized trial elements to making operations carbon-negative, the industry is aligning its goals with broader global sustainability initiatives.

References:

1. First WHO Global Clinical Trials Forum puts forward a global vision for sustainable clinical research infrastructure
2. Clinical Trials Regulation | European Medicines Agency (europa.eu)
3. Improving the environment for clinical research in the EU | EMA Annual Report 2022 (europa.eu)
4. Innovative Health Initiative launches first five projects (europa.eu)
5. IHI call 4 | IHI Innovative Health Initiative (europa.eu)
6. Innovative Health Initiative launches first five projects (europa.eu)
7. Pistoia Alliance Launches Global Community of Interest to Assess the Environmental Impact of Clinical Trials - Pistoia Alliance
8. https://pharmaphorum.com/rd/how-are-clinical-trials-becoming-more-environmentally-friendly
9. www2.iconplc.com/ICON_CARES_2022_ESG_Report
10. www2.iconplc.com/ICON_CARES_2022_ESG_Report
11. Clinical innovation driving sustainable clinical trials (astrazeneca.com)
12. Clinical innovation driving sustainable clinical trials (astrazeneca.com)
13. Clinical innovation driving sustainable clinical trials (astrazeneca.com)
14. AstraZeneca launches company to share digital trial expertise (fiercebiotech.com)

A version of this article was published by Clinical Leader