A recent article published in GaBI Journal, ‘Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials,’ [1] explores how regulators, pharmaceutical companies, and clinical researchers can align with environmental stewardship, social diversity, and equitable governance (ESG) goals for the efficient conduct of clinical trials, including those of biologicals and biosimilars.
The publication, authored by representatives from Biocon Biologics, notes that sustainability awareness has shifted from a focus on environmental issues to a broader commitment to ESG goals. The authors observe that ESG is now a key marker of business integrity and success, influencing consumer, client, and employee choices. Pharma is under pressure to act, including setting Science Based Targets for emissions. The article explores aligning drug development with ESG, highlighting challenges, solutions, and the role of artificial intelligence (AI) in enhancing governance.
ESG in clinical trial strategy
The authors note that ESG progress requires shared responsibility; policymakers and regulators must lead alongside industry. Recent guidance from the UK National Institute for Health Research (NIHR), US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) supports sustainable clinical research.
In the UK, the National Health Service (NHS) has pledged to become carbon net zero by 2050, aiming to reduce its carbon footprint (CO2e), which accounts for a significant portion of the UK’s public sector emissions. As part of this effort, the NIHR released Carbon Reduction Guidelines in 2019, which promote low-carbon clinical trial designs without imposing excessive administrative burdens on researchers.
Globally, the pharmaceutical sector contributes significantly to greenhouse gas emissions, with the industry responsible for 4.4%–4.6% of total emissions. Clinical trials alone contribute substantially to this footprint, with trials consuming resources across both upstream, e.g. drug development, transportation, and waste, and downstream processes, e.g. electricity use, travel for site visits, and data verification. A report has shown that over 350,000 global clinical trials emitted about 27.5 million tons of greenhouse gases by 2021 [2].
Incorporating ESG principles into clinical trial strategies reduces environmental and social impacts, enhances efficiency, accelerates therapy delivery, and ensures responsible risk management through tools like social and environmental impact assessments (SEIA).
WHO Global Clinical Trials Forum for sustainable clinical research
At a World Health Organisation (WHO) meeting in June 2024, building on its 2023 Global Clinical Trials Forum, they set out to define a shared vision for sustainable and high-quality clinical research. This forum gathered a broad spectrum of stakeholders to align on the goals of strengthening clinical trial capacity globally, enhancing coordination, and ensuring trials are responsive to local health needs. The consultation emphasized actions such as increasing domestic funding for trial infrastructure, streamlining regulatory and ethics processes, improving community and patient engagement, enabling trials with digital technologies, training clinical staff, and integrating research within healthcare systems. These steps, the paper suggests, could yield more efficient and inclusive trials that better support public health.
FDA position
The authors further highlight how regulatory bodies like the FDA are encouraging innovation through guidance on the use of AI and machine learning (ML) in drug development. AI/ML, they explain, can transform various stages of clinical trials, from recruitment and stratification to dose optimization, adherence, site selection, data management, and endpoint assessment. AI-enabled tools can facilitate decentralized trials, personalize trial design, and improve retention and data quality, ultimately enhancing efficiency and equity in trial delivery. Notably, AI can also streamline post-marketing surveillance and pharmaceutical manufacturing through predictive analytics and automation.
EU position
Additionally, the paper points to the EU’s Accelerating Clinical Trials (ACT EU) initiative, which promotes decentralized clinical trials (DCTs) as a way to broaden access and improve retention. DCTs, enabled by digital health tools and telemedicine, reduce the need for participants to travel and can make participation more convenient and inclusive. ACT EU’s guidance focuses on harmonizing DCT practices across Member States while maintaining participant safety and data integrity. While some DCT elements, e.g., ePROs and remote monitoring, are already in use, others (like teleconsultation or direct-to-patient drug delivery) need regulatory alignment and further development.
How to make trials more ESG effective
Several strategies for improving ESG efficiency in clinical trials are highlighted:
- Political support for shorter trials with targeted interventions and fewer participants, using real-world data (RWD) to increase efficiency.
- Innovations such as wearable devices, mobile health apps, and telemedicine technologies to increase sustainability in drug development.
- Clinical supply chain addressing gaps such as outdated prognoses and waste through dynamic technologies to improve resource management.
- Reducing trial complexity, duration, and costs by re-evaluating clinical data requirements, such as biosimilar development, where trials can be streamlined through existing evidence.
- Environmental impacts, such as water consumption in drug manufacturing, highlight the need for leaner trials. The use of biopolymers for disposable devices, like pre-filled syringes, and carbon-neutral medical devices are key steps in reducing the carbon footprint.
Regulatory authorities and ethics committees should integrate carbon footprint assessments into clinical trial approval processes, ensuring a long-term commitment to ESG goals.
Carbon footprint of clinical trials case study
The article highlights the use of NIHR guidelines to audit the carbon footprint of clinical trials (the CRASH-1 and CRASH-2), revealing emissions of 924.6 and 508.5 tonnes CO2e, respectively. Key sources included freight in CRASH-1 and energy use in CRASH-2. Faster recruitment and digital tools reduced emissions in CRASH-2. The Low Carbon Clinical Trials Working Group developed a validated method for calculating trial emissions, now applicable to both non-commercial and potentially complex industry-led trials.
Conclusion
The authors concluded that streamlined, scientifically sound clinical trials can support global carbon reduction goals. Trialists should be encouraged to estimate and report potential carbon savings during grant applications. There is a pressing need for tools to measure trial emissions and identify low-carbon practices. Achieving ESG goals requires coordinated action from all stakeholders, including researchers, funders, regulators, and industry.
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Reference
1. Mittra S, Baraskar S, Wolff -Holz E, Athalye SN. Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials. Generics and Biosimilars Initiative Journal (GaBI Journal). 2024;13(3):142-51. doi:10.5639/gabij.2024.1303.033
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