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. 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. Given the clear role of CO2 emissions in climate change, the clinical trial industry must adopt new solutions to improve the 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 SGLT inhibitor, canagliflozin significantly reduces symptom burden in patients with heart failure. 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. 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. Furthermore, almost a quarter of participants involved in cardiovascular clinical studies drop out before completion. 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.
Decentralised Clinical Trials
Decentralised clinical trials (DCTs) describe trials where some of the trial activities take place at sites other than the clinical investigation site, such as the patient’s home or a local clinic. DCTs often involve the use of digital tools and platforms to facilitate communication between research teams and study participants. A notable example includes the DeTAP study – a trial, involving the physiologic monitoring of patients with atrial fibrillation receiving oral anticoagulation therapy. The DeTAP study utilised telemedicine, eConsent, remote monitoring devices, and ePROs collected via a mobile application to fully decentralise research activities. DCTs can improve trial sustainability by reducing the distance or frequency participants travel to clinical study sites and CO2 emissions. The improved accessibility associated with DCTs can help speed up study recruitment, reducing timelines and the need for additional study sites. DCTs can also lead to the more efficient use of energy resources through reduced reliance on physical study sites and the generation and handling of study-related paperwork. However, the manufacture, distribution and use of digital tools and data storage platforms can also contribute to energy usage and CO2 emissions. Nonetheless, one study estimated that the full digitalisation of a traditional clinical study could lead to a more than 90% reduction in energy usage.