By Brittany Wade 

November 1, 2022 | Various stakeholders across the clinical trial enterprise are launching an initiative to reduce the environmental impact of clinical research. Jason LaRoche, Director of Clinical Innovation at Janssen Pharmaceuticals, stands at the helm of this ambitious project, aiming to quantify clinical trial greenhouse gas (GHG) emissions and drastically reduce the adverse downstream effects of research operations. 

Clinical trials are carbon-intensive endeavors and have a tremendous impact on the environment. “If the global healthcare sector were a country, it would be the fifth largest emitter of greenhouse gases, and clinical research is a contributor,” LaRoche tells Deborah Borfitz, Clinical Research News senior writer and host of the Scope of Things podcast.  

The work to quantify clinical trial GHG emissions begins with understanding the climate impact of a single activity, such as a chest X-ray. Under the new project, the team would calculate GHG emissions for a single chest X-ray and multiply that number by the total times an X-ray is performed in a trial. Then, each activity—or measure—would be tallied to determine the total GHG emissions for each study and the overall total for each clinical site.  

Janssen has identified hundreds of thousands of measures to be calculated across the approximate 10,000 clinical facilities under its authority. In building an “inventory of measures,” LaRoche and colleagues can also predict the total GHG emissions for future trials, regardless of the study site or design. The team’s ultimate goal will be to build environmentally sustainable studies in every aspect of clinical research.  

“Once we have that inventory, we can start to form a picture of the environmental impact of a trial. This will allow sustainability to co-inform trial designs as we swap or remove different trial activities—or building blocks—to find a study design that delivers on safety, efficacy, speed, and cost while reducing our impact on the environment,” explains LaRoche. 

Strategies and Solutions 

Earlier this year, Janssen completed a phase I study involving a single European site with 20 randomized patients who, on average, made seven visits to the clinical site after a six-day stint in the hospital. Surprisingly, this relatively modest study generated 17.6 metric tons of CO2 equivalents. 

“The average petrol fuel car generates around 4.1 kg of CO2 equivalents per mile driven. So you could drive your average petrol fuel car around the circumference of the earth 1.7 times before you would generate the equivalent amount of emissions for this one study,” explains LaRoche. 

In a retrospective analysis of the trial, the Janssen team discovered that patients traveling back and forth to the clinical site—including the 140 individuals screened before trial participants were selected—comprised 30% of the study’s total emissions. As a result, a significant portion of their initiative will reduce patient travel as much as possible.  

Adopting more decentralized clinical trials is the obvious choice when looking to decrease travel-related emissions. Researchers can also leverage local pharmacies as clinical sites, incorporate telemedicine, and employ other digital health technologies to minimize or eliminate a patient’s commute. However, a heavy reliance on technology comes with significant concerns. 

“While technology can be a great enabler, it can also have its own environmental impact in terms of greenhouse gas emissions and associated e-waste. So we need to be really careful that the manufacturing and deployment of new hardware doesn’t contribute further to the environmental problem that we’re trying to address,” warns LaRoche. He recommends developing new software to leverage existing hardware rather than pumping out new hardware with every change in study design. 

Janssen also focuses heavily on collaborative initiatives to champion best practices across the industry. For example, the company established a pre-competitive space with organizations like the Sustainable Healthcare Coalition (SHC) and Pistoia Alliance to formulate a collective approach to capturing activity-based measures and their associated permutations.  

A collaborative pre-competitive environment will help industry and academic healthcare entities follow standard methodologies, contribute successfully to the inventory of measures, update their data over extended periods, and share their findings with the other industry members. Starting in early 2023, Janssen, SHC, and the Pistoia Alliance will build a semi-public measure database, with plans for deployment in the second half of 2023. 

Industry regulators and big-name companies are also doing their part to reduce the climate impact of clinical trials. In February, the French Presidency of the Council of the European Union released 16 digital health principles. LaRoche points out that four of those principles focused on “understanding and mitigating the environmental impact of digital health devices” to serve as the foundation for future policy and regulation. 

Additionally, the UK’s National Health Service announced its commitment to being net zero by 2045. Starting in 2028, the organization will require its suppliers to match or exceed its environmental efforts and provide product-specific ecological impact assessments to ensure every product purchased is environmentally sustainable. 

E-Waste in Wearable Health Monitoring Devices 

Wearable devices play a significant role in clinical trials because they allow researchers to administer patient care remotely and—in many cases—continuously. Unfortunately, many of these products are designed as single-use devices due to the risks of biological and chemical contamination. For example, a wearable device worn close to the body can quickly become a deadly fomite, and smart syringes may contain trace amounts of drugs or blood.  

The wearable health device industry is growing rapidly, but industry growth comes at a high price. After approximately 83 million wearable devices were shipped to the European Union market in 2020, 108 million euros worth of raw materials—gold, silver, palladium, etc.—were lost through the incineration or disposal of these single-use devices. 

In a standalone project called DIgital health in Circular Economy (DICE), LaRoche and his team are working with various organizations to diminish e-waste from digital devices by creating a remanufacturing and recycling pipeline for eligible products. 

“Reusability becomes the focus, and recycling is the option of last resort only when the device’s usefulness has been fully depleted,” explains LaRoche. The goal is to remediate contamination risk and extend each device’s useful life, thereby saving money, the environment, and potentially more patient lives.