Building sustainability into trial design
Why sustainable trial design matters
Both public and private sectors are involved in delivering innovative medicines, devices, and interventions to meet the healthcare needs of current and future generations. Testing these for efficacy and safety is essential, but that very testing generates significant resource use and environmental emissions.
There is an urgent need for the clinical research community to actively mitigate its environmental impact, in line with the broader imperative to address the interconnected climate and health crises.
The most effective place to focus emission-reduction efforts is before a trial even starts: in the design phase. Including environmental considerations during early protocol development can embed sustainability by design into trial protocols, rather than retrofitting it later.
⚠ Beware unintended trade-offs. Decisions made to reduce carbon emissions can unintentionally shift them elsewhere or even increase the overall footprint. For example, reducing patient travel may increase medication shipping and staff travel.
Use the Clinical Trials Carbon Calculator scenario functionality to compare design choices and understand trade-offs before committing to a protocol.
Core design principles
Sustainable trial design rests on a handful of interconnected principles that should inform every protocol decision from the earliest planning stages.
Minimise unnecessary procedures
Reduce assessments, visits, and sample collection to the minimum required to protect patient safety and study integrity. Every procedure has an environmental cost.
Localise operations
Select countries, sites, and sponsor teams that minimise travel distances. Localise supply chains, comparators, and lab logistics wherever possible.
Embrace adaptive designs
Adaptive trial designs allow real-time adjustments based on accumulating data, modifying sample size or treatment arms in response to emerging evidence for faster, more efficient trials.
Decentralise where possible
At-home nursing, direct-to-patient investigational product shipments, and decentralised trial (DCT) elements can significantly reduce patient travel burdens and site-visit frequency.
Design for circularity
Plan for device reuse, kit recycling, and surplus management from the outset. Programmes like Kits4Life allow surplus lab supplies to be retained and reused rather than discarded.
Model before you build
Use the Clinical Trials Carbon Calculator v3.0 to compare scenario trade-offs quantitatively before finalising protocol decisions. Data-driven design prevents costly environmental mistakes.
Protocol sustainability checklist
Use this checklist to conduct a detailed review of your protocol through a sustainability lens. Work through each topic area to identify opportunities to embed environmental considerations into your design.
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- Are countries selected to optimise enrolment, unmet need, local site and sponsor logistics, and supply chain operations?
- Are site selection and operational mechanisms optimised to reach patients where they live and work without requiring large travel distances?
- Are site resources local to the respective research sites, and are research teams efficiently resourced?
- Have you optimised the duration of your trial?
- Are procedures, patient visits, and sample collection reduced after the primary endpoint is met?
- Are site resources local to the respective research sites, and are research teams efficiently resourced?
- Have you optimised the number of patients needed?
- Are there opportunities to supplement with synthetic arms or real-world data (RWD)?
- Have you optimised the number of in-person patient visits needed to support endpoints?
- Are at-home nursing, direct-to-patient IP shipments, and decentralised trial (DCT) elements fully explored and implemented?
- Are in-person visits optimised to achieve as many protocol procedures as possible per visit, without undue burden on the patient?
- Have the required protocol procedures been maximally pared down, while still protecting patient safety and study integrity?
- Have you optimised the dosage packaging of your drug to match the dosing schedule?
- Have you localised the supply and reimbursement model of all comparators and non-investigational medicinal products (NIMPs)?
- Have you optimised the size and weight of kits and shippers?
- Have you optimised your IWRS thresholds and have a plan for slow and non-enrolling sites?
- Are you using the latest internal IP supply forecasting tool?
- Are you able to participate in a recycling programme?
- Have you optimised any need for central lab kitting?
- Are the kits minimal in included items?
- Is the kit supply approach pragmatic to when patients will need the requisite kits at site, to minimise expiry and wastage?
- Does this study require any supportive technology or devices?
- Is a BYOD (bring your own device) model feasible for this study?
- Can you use refurbished devices?
- What is the process for returning devices at the end of the trial?
- Can the devices be reused or recycled?
- Are site selection and operational mechanisms optimised to reach patients where they live and work without requiring large travel distances?
- Has the sponsor team been localised to the extent possible to ensure strong team connections without global travel needs?
- Are local teams clustered directly in the cities of the research sites they support?
- Are operational mechanisms optimised such that the sponsor team is efficiently resourced?
- Have you minimised any need to procure and provide consumables centrally?
- If central consumables are required, do you have a strategy in place for optimising supply chain, localising transport, and minimising waste?
- Are central lab logistics required to meet study endpoints?
- Is every required sample directly tied to a study endpoint in the CSR?
- Are you only retaining samples for required key time points?
- Are back-up aliquots only shipped and stored when the primary aliquot is insufficient?
- Are you maximising the utility of the latest technology to assess multiple endpoints in one assay versus multiple assays?
- Are ambient assays maximised over frozen assays?
- Are biobank storage locations chosen to match sustainable energy grid locations?
- Is sample pooling and shipment consolidation supported by the operational plan?
- Are local assays maximised over central assays?
- Do you have a plan for surplus lab kits at the end of the study (e.g. Kits4Life, or site contracts that allow kitted supplies to be retained)?
- Do you have a strategy in place to optimise lab kit supply chain, localise transport, and minimise waste?
- Is an in-person Investigator Meeting required for your study?
- Is a fully remote or regional set of meetings adequate?
- Can a hybrid meeting be equally successful?
- Are all general study management meetings planned for remote attendees?
- Have you reduced and potentially eliminated SDV, and leveraged EHR-to-sponsor in your operational design?
- Have you optimised risk-based monitoring and utilisation of remote monitoring capabilities to minimise on-site travel?
