Sustainable Clinical Research 2025: Key Data, Industry Initiatives, and Future Directions

1 – Introduction

Sustainability means living within the limits of our planet and our societies so that communities and economies can keep thriving long into the future. It is usually described through three connected dimensions:
  • Environmental: Caring for natural ecosystems and finite resources while reducing and where possible reversing pollution and loss of biodiversity.
  • Social: Treating people fairly, safeguarding human rights, and helping communities remain healthy and resilient.
  • Governance/Economic: Building businesses and economies that stay adaptable and successful without depleting natural or social capital.
In clinical research, these principles should guide the way studies are planned and conducted. The goal is to protect resources, support the communities involved, and uphold scientific integrity so that medical innovation can continue to improve human health without placing unnecessary strain on the environment or the broader social and economic landscape. Reducing the carbon footprint of clinical studies is essential not only to support the global net-zero goals, first articulated in the 2015 UNFCCC Paris Agreement and reinforced by IPCC science, calling for net-zero CO₂ emissions by 2050, but also to protect the long-term viability of clinical research and ensure continued patient access to innovative therapies. Additionally, a landmark white paper, ‘Embedding Sustainability in Clinical Trials’ [1], estimates that aligning clinical studies with a net-zero roadmap could save healthcare systems up to US $1.1 trillion by 2050. This figure underscores the economic as well as environmental stakes.

Contents

1 – Introduction

2 – Present Situation

3 – Progress So far

4 – Gaps and Challenges

5 – What Needs to Happen Next?

6 – Conclusion

7 – References

2 – Present Situation

Healthcare accounts for around 5% of global greenhouse-gas emissions [2], a sizable footprint for a sector devoted to protecting human health. Clinical studies contribute meaningfully to that impact through their complex logistics, international travel, and high use of consumables [3]. Sustainable clinical research therefore calls for action across the three connected dimensions:
  • Environmental sustainability: Minimise unnecessary site visits, expand remote or hybrid monitoring, streamline shipping routes, cut single-use plastics, and select vendors with demonstrably greener practices.
  • Social sustainability: Ensure diverse and equitable participant recruitment, protect patient rights and privacy, and invest in local research capacity so host communities gain lasting benefits beyond the study itself.
  • Economic sustainability: Design clinical studies to be cost-efficient and operationally resilient, reducing protocol amendments and site dropouts while safeguarding data quality and regulatory compliance.

3 – Progress So Far

The movement to decarbonise clinical research has accelerated markedly with the introduction of the following initiatives:
  • Industry Low-Carbon Clinical Trials (iLCCT) initiative A multi-stakeholder program led by the Sustainable Healthcare Coalition (SHC) and partners. Launched publicly in early 2025, it provides a Carbon Calculator for clinical studies and implementation guidance, allowing Sponsors to measure and reduce the footprint of Phase II – III clinical studies [4].
  • Sustainable Markets Initiative (SMI) Health Systems Task Force Formed at COP26 (2021) to drive net-zero strategies across healthcare [5]. Major pharma companies such as AstraZeneca, GSK, and Novartis participate.
  • Corporate roadmaps Companies like AstraZeneca began detailed life-cycle analyses of clinical studies in 2020 and are embedding low-carbon practices, hybrid designs, optimised supply chains, and greener labs [6].
  • Academic and collaborative efforts The MRCT Center launched its Environmental Sustainability in Clinical Trials project in 2024 [7], while the Greener Trials Toolkit from the UK’s Institute of Cancer Research and partners went live in January 2025 [8].
These initiatives collectively aim to integrate sustainability from the outset meaning environmental, social, and economic considerations are integrated into every stage of the clinical study rather than treated as optional add-ons. Specific foundational areas of action include:
  • Protocol development: Sponsors incorporate hybrid or decentralised visit schedules and patient-centric logistics to cut travel and emissions [9]. Example: AstraZeneca began life-cycle analyses in 2020 and redesigned protocols to include hybrid visits and optimised travel routes [6].
  • Operational planning: Sites and third-party vendors are chosen not only for capacity and cost but also for renewable-energy use, waste management, and equity commitments. Example: The Greener Trials Toolkit [8] provides a scoring framework for site selection and lab sustainability certification.
  • Measurement and benchmarking: Emissions are quantified and tracked across the lifecycle using standardised tools. Example: The Industry Low-Carbon Clinical Trials (iLCCT) Carbon Calculator [4] lets Sponsors input travel, supply-chain, and energy data to generate total CO₂e per participant (further detail later).
  • Governance: Oversight committees and sustainability leads are embedded within clinical study governance to ensure accountability. Example: The MRCT Center Environmental Sustainability Project [7] recommends appointing a sustainability lead and integrating environmental Key Performance Indicators into Good Clinical Practice oversight.
  • Continuous improvement: Lessons learned feed into future protocols and shared industry standards. Example: The BIP UK “Embedding Sustainability in Clinical Trials” white paper [1] urges public reporting of carbon metrics and inter-company sharing of best practices to refine guidance and drive industry-wide adoption.
By incorporating these elements into design and governance, sustainability shifts from an aspiration to a day-to-day operational requirement positioning clinical research to support healthcare’s global net-zero by 2050 targets while safeguarding clinical study quality, participant safety, and operational resilience.

4 – Gaps and Challenges

Despite momentum, several hurdles remain:
  • Regulatory clarity: Neither FDA nor EMA has yet issued binding requirements; most activity is voluntary.
  • Evidence base: While decentralised clinical studies reduce participant travel, full life-cycle data on their net carbon benefit are still limited. Current frameworks are being built to track this, criticisms remain about data completeness and applicability.
  • Training and awareness: A 2024 Irish oncology survey [10] found strong willingness to adopt green practices, but only 21% of professionals knew of any guidelines and fewer than 6% had received training.
  • Climate impacts on clinical studies: Floods, wildfires, and other climate-related disruptions are already affecting clinical study logistics, site access, and clinical study conduct [11].

What challenges or successes have you seen in integrating sustainability into clinical studies this year?

5 – What Needs to Happen Next

(informed by current industry guidance and published references)

5.1 – Standardise Measurement

Broad adoption of the Industry Low-Carbon Clinical Trials (iLCCT) Carbon Calculator [4] is essential so Sponsors, CROs, and investigative sites can estimate and track the GreenHouse-Gas (GHG) footprint of a clinical study from start-up through close-out.

5.1.1 – How the Calculator Works

  • Data Inputs: Covers the entire study lifecycle, including:
    • Protocol & Start-up (number of sites, planned patient visits, decentralised elements such as telehealth or home nursing),
    • Participant and Staff Travel (distances and transport modes for participants, monitors, investigators, and courier shipments), and
    • Clinical Supplies & Laboratories (volume/weight of consumables, cold-chain requirements, frequency of sample shipments).
  • Methodology: Applies emission factors based on UK DEFRA and other international datasets to generate CO₂-equivalent (CO₂e) outputs per category and for the study as a whole.
  • Outputs: Provides total carbon footprint (kg or tonnes of CO₂e), stage-by-stage breakdowns (e.g., participant travel, supply chain, monitoring visits), and sensitivity analyses to show how protocol changes, such as replacing in-person with hybrid visits alter emissions.

5.1.2 – Use in Study Design

The output from the calculator can inform protocol adjustments such as fewer in-person monitoring visits, consolidated sample shipments, selection of lower-carbon couriers, or renewable-powered data centres. Planned reductions should be documented in the clinical protocol and/or a study-specific Sustainability Plan.

Sponsors are encouraged to begin using the calculator early in protocol development to influence design decisions and to benchmark against previous trials or industry averages. Data should be updated throughout the study to track actual versus planned emissions.

5.2 – Integrate into Regulation and Funding

Regulators and major funders should require carbon-impact reporting and incentivise low-emission clinical study designs. Potential mechanisms include:
  • Regulatory submissions: Add a carbon-impact section to Clinical Trial Applications, marketing applications, or periodic safety/progress reports, similar to how adverse events are currently documented.
  • Research-funding processes: Require a carbon-footprint estimate and Sustainability Plan in grant proposals and annual progress reports (e.g., NIH, Wellcome Trust, Horizon Europe, UK NIHR).
  • Public or industry registries: Expand registries such as ClinicalTrials.gov or the EU Clinical Trials Register to include an “environmental impact” field for transparency and benchmarking.

5.3 – Expand Training

Integrate sustainability content into Good Clinical Practice and investigator training worldwide. Modules should cover carbon-measurement basics, low-emission clinical study design, and third-party vendor engagement.

5.4 – Scale Digital and Hybrid Models Thoughtfully

Adopt decentralised and hybrid approaches only after confirming they genuinely reduce emissions and do not compromise data integrity, participant safety, or equitable access.

5.5 – Set Clear Milestones

Align clinical research with healthcare’s broader net-zero by 2050 target, establishing interim benchmarks (e.g., 2030 emission-reduction goals) to track and accelerate progress.

6 – Conclusion

Sustainability in clinical research has shifted from a peripheral “nice-to-have” to an industry-wide imperative.

A combination of factors, robust data on healthcare’s carbon footprint, compelling economic incentives, and emerging global standards is driving this transformation.

Together, these forces make 2025 a pivotal year: Sponsors, Contract Research Organisations, and investigative sites are beginning to treat carbon accounting and low-emission clinical study design as core operational requirements rather than optional pilots.

Embedding sustainability into protocol development, site selection, monitoring approaches, and data management now allows the sector to cut its environmental impact while safeguarding the long-term viability of clinical innovation.

This ensures that future studies remain feasible, cost-effective, and resilient in a warming world.

By moving sustainability from aspiration to everyday operational practice, clinical research secures its own future as well as the health of the planet.

7 – References

  1. BIP UK. Embedding Sustainability in Clinical Trials. White Paper, 2024.
  1. Rodríguez-Jiménez L. et al. The carbon footprint of healthcare settings: A systematic review. Journal of Advanced Nursing, 2023.
  1. Downey G.P. et al. Medical Industry Contributions to the Climate Crisis. Front Public Health, 2023.
  1. Sustainable Healthcare Coalition. Industry Low-Carbon Clinical Trials (iLCCT) Carbon Calculator and Guidance. Global Forum, DIA, March 2025.
  1. Sustainable Markets Initiative (SMI) Health Systems Task Force. COP26 launch statement, 2021.
  1. Driving sustainable clinical trials: Harnessing clinical innovation to reduce environmental impact [Internet]. 2024 Sep 3
  1. MRCT Center. Environmental Sustainability in Clinical Trials Project. 2024.
  1. Institute of Cancer Research, NIHR et al. Greener Trials Toolkit. January 2025.
  1. Applied Clinical Trials / DIA Global Forum articles on decentralized-trial emissions and regulatory landscape, 2024–2025.
  1. Clayton-Lea A, Flynn CR, Hopkins C, O’Reilly S. Stepping Stones to Sustainability Within Cancer Clinical Trials in Ireland. Curr Oncol. 2025;32(8):446
  1. Springer Nature Research Communities. Climate change disruptions to clinical trials. 2024.