Sustainability in clinical drug trials

EN Vastuullisuus kliinisissä lääketutkimuksissa

In clinical drug trials, the main sources of emissions typically include the dispatch and transport of investigational drugs, energy consumption at trial facilities, travel by participants and research staff, packaging materials, laboratory supplies and the use of medical disposables.

The CO2 emissions of one clinical trial may vary between approximately 80 and 2,000 tonnes of CO2 equivalent for the duration of the trial. Typically, emissions increase as the trial progresses, because the number of participants, the samples taken from them and research centres in subsequent trials is higher. In addition, a later phase trial lasts longer than an early phase trial.

Sustainability and methods for reducing the carbon footprint should be taken into account already in the early planning of the trial and in the research protocol from the beginning.

The carbon footprint can be reduced, for example, by increasing digitalisation, utilising artificial intelligence to detect risks, optimising transport, improving resource and energy use, reducing pharmaceutical and other waste, rapid intake of participants, and reducing travel by participants and research personnel. In addition, in sustainable operation, environmental protection aspects must be taken into account. The guideline for good research practice (ICH GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)) must be applied to these different implementation environments.

Below are some ways in which the carbon footprint of clinical trials can be reduced:

EN Vastuullisuus kliinisissä lääketutkimuksissa (alasvetovalikot)

1. Transitioning from paper documents to electronic systems such as electronic reporting forms (eCRFs) and electronic results reported by participants (ePRO). This reduces paper waste, simplifies and speeds up data management, and consolidates data in one place.
2. Meetings taking place remotely whenever possible, for example, in training, pre-screening, interim examinations and follow-up examinations. This reduces emissions from travel and facilitates the participation of both the research team and participants.
3. Meeting the participants of the trials remotely. Slow intake of participants and high discontinuation rates lead to useless operational emissions and energy consumption and increase the costs to the sponsors of trials. Recruiting participants in a remote meeting speeds up intake, lowers the participation threshold and enables participation from a wider geographical area, allowing for a faster start of the trial.
4. Utilising digital meters or remote measurement, such as smart watches or sensors. The travel of participants to research centres may be reduced. However, the recyclability of the equipment must be ensured.
5. Utilising artificial intelligence. For example, targeting the intake of participants, quality control of research data and improving transport chains using artificial intelligence may reduce emissions. However, the benefits of this should be assessed in relation to the increased use of energy. Energy is as environmentally friendly as how it is produced.
1. Using remote meetings and telephone contact whenever possible. This reduces visits to research centres and facilitates participation in research.
2. Partial or full decentralisation of trials, where possible. This reduces participants’ travel needs, which supports accessibility and reduces emissions. However, the safety of the participants and the responsibility of the principal investigator must be taken into account. Instructions for designing decentralised elements: Decentralised elements in clinical trials (health.ec.europa.eu, pdf).
1. Optimisation of the dispatch of investigational drugs, laboratory or tissue samples and other examination supplies. The planning and combining of consignments reduces unnecessary transport, reduces costs and reduces emissions from transport. More information about the additional labelling of investigational medicine packages (in Finnish). In different trials, it is advisable to make the test tubes (trial kits) similar so that they can be used varyingly in different trials and unnecessary expiration is reduced.
2. Favouring local or domestic service providers. Shorter transport distances reduce emissions and can speed up deliveries. When choosing service providers, operators with sustainability reporting or, for example, an EcoVadis rating can be favoured. EcoVadis is a globally recognised platform that offers companies sustainability ratings.
3. Using local blood testing whenever possible. Taking the samples close to the participant and only once (that is, no repeated sample to a central laboratory) enhances the workflow and reduces travel and sample submissions, which in turn reduces the carbon footprint of transports.
1. Careful planning of the trial before starting. A well-crafted research plan reduces the number of actions that are unnecessary from the perspective of endpoints and the reporting of results. It also reduces and facilitates on-site monitoring. This improves resource efficiency and reduces total energy consumption.
2. Using carbon footprint tools, checklists and guidelines already at an early stage of research planning. These tools can be used to identify areas of the carbon footprint of the trial that can be most effectively influenced in order to reduce emissions. A commonly used calculator is, for example, the Clinical Trial Carbon Calculator.
1. Avoiding excessive amounts of investigational drugs, supplies and packaging materials. Careful planning, for example, regarding the package size of investigational medicinal products taken at home and sufficient preparation before starting the trial, prevent the acquisition and use of unnecessary materials.
2. Reusing materials. For example, recycling packaging, donating or reusing unused laboratory supplies, and favouring environmentally friendly packaging materials reduce the amount of waste and support the circular economy.
3. Utilising centralised waste management practices. In accordance with Article 51 of the EU Clinical Trials Regulation (eur-lex.europa.eu), the investigational medicinal product shall be disposed of in a suitable and proportionate manner. The marketing authorisation of the investigational medicinal product must also be taken into account and the measures described in the research plans. Typically, in non-commercial trials involving investigational medicinal products subject to marketing authorisation, centralised waste management for pharmaceutical waste ensures consistent, regulated and environmentally safe disposal.

Kieliversion valinta

Kieliversion valinta

Sustainability in clinical drug trials

EN Vastuullisuus kliinisissä lääketutkimuksissa

EN Vastuullisuus kliinisissä lääketutkimuksissa (alasvetovalikot)

Kieliversion valinta

Kieliversion valinta

Sustainability in clinical drug trials

EN Vastuullisuus kliinisissä lääketutkimuksissa

EN Vastuullisuus kliinisissä lääketutkimuksissa (alasvetovalikot)

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