The clinical trial industry is essential for ensuring the safety and efficacy of new medicines; however, it is also a significant contributor of greenhouse gas emissions. The Sustainable Healthcare Coalition estimates clinical trials may be responsible for up to 100 megatons of CO₂ emissions annually, about the same emissions produced by a country the size of Belgium.¹ The main sources of these emissions are thought to include trial-related travel by study participants and site staff, deliveries of trial equipment and energy usage by clinical study sites.² Given the clear role of CO₂ emissions in climate change, the clinical trial industry must adopt new solutions to improve sustainability, while enhancing patient access and retention as well as the patient experience. Those solutions that are showing promise include patient-centric study designs, virtual clinical studies, adaptive study designs, electronic patient-reported outcomes (ePRO), and the use of digital technologies.

Patient-Centric Study Designs
Patient-centric study designs consider a patient’s needs and preferences with the aim of reducing the burden on study participants. Those patient-centric approaches that may impact trial sustainability include the use of shorter trial durations and reductions in the frequency and number of required clinic visits, e.g., using remote monitoring technologies or telemedicine. An example of a patient-centric study design can be seen in the CHIEF-HF trial, which aimed to evaluate whether the SGLT2 inhibitor, canagliflozin, significantly reduces symptom burden in patients with heart failure.³ This trial was designed to reduce the need for in-person visits with direct engagement of patients through a study website, electronic informed consent, direct home delivery of study medication, reporting of the primary endpoint by a mobile application, and use of a Fitbit to monitor activity.³ Patient-centric approaches can make trials more convenient for patients through fewer patient journeys, which in turn can lower fuel consumption and help reduce CO₂ emissions. The involvement of patients in the design of clinical trials can also benefit patient recruitment and retention. It is estimated that more than 80% of clinical studies face problems with study recruitment resulting in delays and the need for additional study sites.⁴ Furthermore, almost a quarter of participants involved in cardiovascular clinical studies drop out before completion.⁵ Through improved recruitment and retention, patient-centric approaches can help reduce the number of participants required to meet the study outcomes and the resources needed to complete the study.