Thermo Fisher interview: Making clinical trials more sustainable by digitization and decentralization

Sustainability and eco-friendliness have become key considerations among consumers, corporations and countries. In the clinical trials arena, patient burden, diversity and inclusion, and e-consent – all of which are incredibly important, are all hot topics, but what about the planetary burden?

To learn more about how digitizing, decentralizing and near-patient solutions can reduce the environmental impact of clinical research, we spoke with Michael Cohen, senior director, digital and decentralized solutions at the PPD clinical research business of Thermo Fisher Scientific, about making clinical trials green.

OSP: Those in health care play an important role in developing new treatments for cancer and other diseases, in particular  putting a great deal of effort into helping to address the COVID-19 pandemic. Why do you think we should we be concerned about the environment while professionals are busy saving lives? Shouldn’t the sustainability effort be focused on industries like manufacturing, shipping and transportation that seemingly have a greater impact on the environment?​

For many of us in the health care industry, we recognize the intrinsic connection between environmental health and human health. As a world leader in serving science, Thermo Fisher is keenly aware of the importance of sustainability efforts across the full health care continuum, from design of products all the way through to clinical trials and scaled manufacturing. Driving sustainable clinical trials is just one piece of a wider effort to improve our footprint across the health care ecosystem, all while continuing to serve customers and patients. We firmly believe that every activity across the value chain is critical to achieving our sustainability commitments.

The U.S. Centers for Disease Control and Prevention has identified four factors of climate change – rising temperatures, more extreme weather, rising sea levels and increasing carbon dioxide levels – that pose risk to human health. All four can be directly aligned with worsening population health. For example, extreme weather and pollution exacerbate asthma, as well as pulmonary and cardiovascular diseases. Rising sea levels impact water quality and could lead to outbreaks of cholera and cryptosporidiosis. The United Nations reports predict a doubling by 2050 of vector-borne disease in Africa due to rising temperatures, changing rainfall patterns and extreme weather. In the U.S., we’ve seen Lyme disease explode in incidence, but also move further from historic Lyme centers, which the U.S. Environmental Protection Agency uses as an indicator of climate change. Overall, human health and planetary health are intrinsically connected, just like any other animal and its ecosystem.

OSP: That makes sense, but how much change can the clinical trials business actually make?​

Overall, while modern health care obviously saves millions of lives, it does so at a major environmental cost. For instance, the average MRI scan emits the same amount of carbon as driving a sedan about 90 miles. Hospitals, between shipping lab samples, lighting, heating, cooling and other necessary activities, emit 2.5 times more greenhouse gas (GHG) than a similarly sized commercial building. Globally, health care is estimated to be responsible for approximately 4.5% of world GHG emissions. We like to think in terms of countries, so if medicine were a country, it would be the fifth largest emitter of GHG behind China, U.S., India, and Russia. If clinical trials were an independent state, we’d have about the same emissions as Belgium or Kuwait or the states of North Carolina or New Jersey.

Any potentially reducible waste, emission or water usage helps the planet. Our do-no-harm mentality must also include the planet’s health.

OSP: It surprises me that clinical trials emit as much greenhouse gases as North Carolina... What are the key parts of a trial that attribute to a carbon footprint?​

Generally, we find that the emissions attributable to clinical trials through an activities-based approach can be approximated by:

1)     Trial site utilities (heating, air conditioning, lighting, electricity use) -10-15%

2)     Patient, staff and monitoring commuting/travel -15-40%

3)     Manufacturing, IP, samples, devices -15-25%

4)     High CO₂ ​procedures, vendor services, etc. -10-15%

We acknowledge that clinical studies can vary greatly. For example, Phase I studies with overnight stays will see a sizeable contribution from those accommodations, while other studies with intensive visits, infusions or large number of trial participants may see a skewed distribution.

Overall, each trial – even a small one – has a meaningful carbon footprint. For example, a small Phase I trial with a couple dozen patients can have the same impact as driving a family car around the globe almost twice!⁸​

OSP: So what can can be done when looking at protocols and thinking about greener clinical trial strategies?​

We get this question all the time. The most important thing is that we run a high-quality clinical trial. Sacrificing quality, necessary endpoints or any other integral part of the trial in the name of sustainability makes the entire use of carbon a tragic waste.

Thermo Fisher Scientific is committed to helping its customers and partners identify more environmentally friendly solutions. We are dedicated to reducing Scope 1 and 2 GHG emissions from our operations by 50% by 2030 from a 2018 baseline and achieving net-zero emissions by 2050. We are employing a multi-pronged approach that includes transitioning away from fossil fuels and accelerating the adoption of renewable energy to power our U.S. facilities and clinical sites with 100% renewable electricity by 2026. At the same time, we are engaging with 90% of suppliers – our largest source of Scope 3 emissions – to set science-based targets by 2027, we have submitted our climate targets to the Science Based Targets initiative for validation and we are designing products that help scientists advance sustainability in the lab with the environment in mind.

When we evaluate clinical trials, we’ve found that the following keys should be considered at the initial planning and design stages:

1)     Protocol efficiency – Any unnecessary assessments or exploratory endpoints that can be trimmed without undermining the trial objective will immediately reduce patient and planetary burden.

2)     Population size – Reductions in participant number, such as through synthetic control arms, digital twins, or shared control arms, can make a marked reduction in footprint.

3)     Near-patient decentralization – By leveraging near-patient solutions like local pharmacies or mobile sites, we can bring studies to patients to reduce their travel to the research site and be more patient- and planet-friendly.

4)     Digitization – If we can use digital tools to make data capture easier for sites through automation, we can reduce staff burden and paper usage.

5)     Monitoring and qualification – The use of remote monitoring and other technology can reduce the travel for CRAs to sites.

6)     Clinical supplies management – Various organizations are doing a great job of donating clinical trial supplies so they can be reused instead of wasted, which helps offset the carbon footprint of devices and medical supplies in clinical trials.

One area that we are specifically excited about within Thermo Fisher’s clinical research business is how digitizing, decentralizing and near-patient solutions can help lower our clinical trials carbon footprint. We can use data to predict how the mix of site selection may increase or decrease the emissions of a study. How many of us have asked what percentage of sites are near a bus stop or subway station? What kind of HVAC systems are your sites using? Do your clinical research coordinators reuse their towels when staying at a hotel? Can the investigator meeting be held virtually? What if the trial participants could conduct their visits, shop for groceries and pick up a concomitant medication at their retail pharmacy all at the same visit location? In the past, we’d never ask these questions. But now, these and many others are taking center stage as we seek ways to reduce our carbon footprint.

OSP: Finally, what can others do to get involved? How are the industry tackling this problem?​

There is a growing number of people thinking about these problems and working to make clinical trials both patient- and earth-friendly. For example, Thermo Fisher and its PPD clinical research business are members of the Pistoia Alliance, a not-for-profit organization with members from pharma, CROs and technology organizations working together to create standards for activity-based carbon-footprint calculations for decentralized trials. The Sustainable Healthcare Coalition has a Low Carbon Clinical Trials Consortium, which also is looking at carbon-heavy usage in clinical trials as part of a larger health care sustainability movement.

Within clinical trials themselves, we are building systems and benchmarking tools to help us and our customers make planet-friendly choices throughout the clinical trials research process.

We hope by raising awareness that more in our business will discuss and consider carbon footprint, water usage and waste in the clinical trial process so that, together, we can run greener clinical trials and ensure that our planet can continue to support human health. Human health is planetary health and patient burden is inextricably tied to planet burden.