Building sustainability into trial design

Both public and private sectors are involved in delivering vital innovative medicines, devices and other interventions to meet the healthcare needs of current and future generations. These need to be tested for their efficacy and safety before they can be used with confidence but, that very testing leads to resource use and environmental emissions. The most effective place to focus efforts to reduce those emissions is before a trial is even started in the design phase.

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. Our partnership with Johnson & Johnson looks forward to sharing its learning to support those efforts as we continue to work together to tackle the climate crisis.

Examples of carbon hotspots in a clinical trial have been identified below. Consider ways to mitigate these hot spots when designing your trial, such as:

 

Decentralised or hybrid trial models

  • These allow participants to participate from their homes or local clinics, reducing the need for travel to central trial sites. This approach decreases carbon emissions associated with travel and energy consumption required for large trial facilities. DCTs can also improve recruitment and retention by making participation more convenient.

Adoption of digital solutions

  • Implementation of digital technologies such as e-consent forms and wearable devices for automated data capture can significantly reduce paper use, streamline operations and enhance data accuracy.

Sustainable site selection and logistics

  • Selecting clinical trial sites that are easily accessible by public transportation or located near research institutions and medical centres can reduce the need for individual transportation and associated carbon emissions.
  • Sustainable procurement practices, such as using energy-efficient equipment and materials made from recycled sources, can further minimise the environmental impact of the trial.

Adaptive trial designs and real-time data analysis

  • Adaptive trial designs allow for real-time adjustments based on accumulating data. This enables researchers to modify aspects of the trial, such as sample size or treatment arms, in response to emerging information. This leads to more efficient and faster trials.

Environmental impact assessment and waste reduction

  • During protocol development, consider the environmental impact of study procedures, such as reducing waste through recycling programmes, proper disposal of hazardous waste, and using renewable energy sources.
  • Predictive models can be developed to estimate and reduce CO2 emissions from patient travel and other trial activities.