On March 6, 2024, the U.S. Securities and Exchange Commission approved a rule to require some companies to report some of their carbon emissions (Scope 1 and 2, but not Scope 3)1. While some feel this rule doesn’t go far enough, it certainly demonstrates the need to better understand our respective carbon footprints and develop solutions to reduce our environmental impact. Many major biopharmaceutical companies have science-based, net-zero targets set for no later than 2050. As this is decades away, one might think action today is not urgent. This is not the case. Consider a thought experiment for Fictitious Pharmaceutical Company (FPC) and its carbon footprint. Draw a straight line (real glide paths are not a simple linear expression) from where FPC is in 2024 to net zero by 2050 (see Figure 1). This will allow FPC to align with the Paris Agreement and science-based targets generally (see Figure 1). Or more mathematically, FPC must reduce its absolute emissions from its baseline year by at least 90% by the year 2050 (for simplicity we are using 2024 as the baseline). This will enable FPC to align with keeping global temperature increases to 1.5°C by 2050 as called for by the Paris Agreement2.
Figure 1: Fictional glide path for Fictitious Pharmaceutical Company (FPC) and its carbon footprint.
As FPC has established goals that extend across its entire organization, clinical trials must also be set on a similar glide path down toward net zero because clinical trials are not exempt from FPC’s corporate sustainability goals. Globally, clinical trials as an industry have a carbon footprint of somewhere between 37 and 100 megatons of greenhouse gas emissions or CO2e.3 This equates to an annual footprint between the size of Sweden and Belgium4.
Figure 2: Johnson & Johnson Innovative Medicine sunburst plot
Returning to FPC and its carbon footprint of clinical studies, how does one walk down this path to net zero? If we consider the literature, there are a few key areas we can focus on, but here we will consider clinical research associate (CRA) monitoring visits, since the flights, trains, rental cars, taxis and hotel stays accumulate greenhouse gas emissions ranging from 4% to 20% of the trial’s total carbon impact.5 Johnson & Johnson Innovative Medicine has prepared a sunburst plot (see Figure 2) that summarizes some of their literature.6 In their analysis, they found on-site monitoring accounts for 11% of the entire trial footprint, so they are well within the 4%-20% range of FPC’s clinical trial footprint. For our purposes, we will assume CRA monitoring is 20% of clinical trial carbon footprint.
Returning to FPC, let’s assume it needs to reduce emissions by about 10% by 2026 to keep up with its glide path (Figure 1). Suddenly, CRA monitoring visits seem like a great area on which to focus. If we reduced CRA visits associated emissions by half, we could realize a net reduction of 10% for the entire study.
What does a typical CRA visit look like from a carbon footprint perspective? Let’s assume the average trip includes a flight or a train ride; a car rental, ride share or taxi; and, of course, a hotel stay. We calculated that the average CRA trip emits approximately 550kg CO2e,7 or about the same annual footprint as someone from Nigeria8.
Recognizing there are many different types of CRA visits, for our purposes, we assumed that from a travel perspective, all visit types look the same regarding travel. So how can we reduce the environmental impact of these visits? Sustainable aviation fuel (SAF) is an emerging option to significantly reduce the carbon footprint of air travel, but availability of SAF remains low and certificate schemes are not currently approved by the Greenhouse Gas Protocol. In fact, Virgin Atlantic had the first 100% SAF flight from Heathrow Airport to John F. Kennedy International Airport on November 28, 2023,9 so clearly this technology is not widely available to cover all CRA trips. FPC could have all clinical trial monitors request “green” ride-share taxis, or rent electric vehicles, but these are not available everywhere, and may only promise “at least 55% fewer carbon emissions” 10 We can provide colleagues with travel footprint data, routing support and other tools to better understand their carbon footprint and help them make more sustainable choices. However, this alone will not make a significant reduction in FPC’s carbon footprint.
So the obvious conclusion is that we have to be more selective on when we visit and who is conducting the visit (namely where they live and how far they are travelling to the site).
Figure 3: Thermo Fisher Scientific’s 360° monitoring model
The PPD clinical research business of Thermo Fisher Scientific has adopted a 360° monitoring model (Figure 3), consisting of continual remote, onsite and centralized monitoring. The model aims to reduce reliance on episodic onsite monitoring and making site monitoring and data review a continual, real-time process. In this model, we strive to assign onsite CRAs within close proximity to a research site (approximately within four-hour roundtrip). This CRA develops a deep site knowledge and relationship with a particular site, but they are only sent when the outcome of the continuous data monitoring or risk indicators triggers the need for an onsite visit. Based on our own internal data, we see 23% fewer CRA visits across almost 40 studies and multiple therapeutic areas.11 We also see that when a CRA does visit the site, they are locally assigned monitors. This results in an 18.5% reduction in visit emissions when the local monitor does need to conduct in-person visits.12 If FPC were able to utilize this type of 360° monitoring, they could realize a 37% CO2e reduction across multiple therapeutic areas (see Figure 4).
Figure 4: Environmental impact of implementing 360° monitoring across multiple therapeutic areas for 39 studies.
Benefits go beyond reducing environmental impact, as 360° monitoring results in faster entry into the electronic data capture system and sites appreciate the reduction in visits and time on site. Overall, 76% of sites rated this monitoring strategy as good as or better than traditional monitoring strategies.
Now, returning to our glide path for FPC and its team deploys 360° monitoring-type strategies across their portfolio, they could reduce their global clinical trial emissions by approximately 7% — just in time for the 2026 target!
CRA monitoring is an incredible area of opportunity to deploy strategies that are both better for sites, the CRAs and the environment. Recently, we’ve seen pharma partners reduce in-person source data verification to incredibly low levels (approximately 20%), while other organizations maintain 100% in-person source data verification (SDV). However, challenges remain, such as sites allowing remote access and regulations that may not allow a future of 100% remote SDV. The 360° monitoring model embraces improvements to technology that enable remote review and embraces growing client and regulatory acceptance of risk-based quality management (RBQM) principles enabling our approach to reduce SDV% by reassessing critical data and defining those data points to target and refocus time from SDV/SDR to higher-value on-site activities and deploy continual remote monitoring.
Michael Cohen
There’s a growing notion in clinical research that yesterday’s decentralized clinical trial is today’s clinical trial. This idea that we must decentralize, digitize and modernize trials obviously became paramount during the COVID-19 pandemic, but today we see that these strategies can help improve a study’s resilience, ability to attract and retain diverse patient populations, and improve quality and cost.13 But these strategies also benefit the environment. Considering CRA monitor visits, the more we can leverage digital and decentralized resources and strategies, the more we can drive environmental sustainability within clinical trials.
Michael J. Cohen, MSc, MBA is senior ∂irector, lead, environmental Sustainability, PPD clinical research business at Thermo Fisher Scientific.
References
1 Naishadham, S. “SEC approves weakened climate rule requiring some companies to report emissions.” Associated Press. March 6, 2024.
2 “For a livable climate: Net-zero commitments must be backed by credible action.” Net Zero Coalition | United Nations
3 Sustainable Trials Study Group. Towards sustainable clinical trials. BMJ. 2007 Mar 31;334(7595):671-3. doi: 10.1136/bmj.39140.623137.BE. PMID: 17395948; PMCID: PMC1839193.
4 G.; Rossi, S.; Brandao De Melo, J.; Oom, D.; Branco, A.; San-Miguel, J.; Vignati, E. (2023). GHG emissions of all world countries — 2023. Luxembourg: Publications Office of the European Union. doi:10.2760/953322. Retrieved 1 November 2023.
5 Mackillop N, et al. Carbon footprint of industry-sponsored late-stage clinical trials. BMJ Open. 2023 Aug 21;13(8):e072491.
6 Courtesy of Jason Lanier, Director, Global Program Leader, Johnson & Johnson Innovative Medicine.
7 Manns, J., Cohen, MJ. “Addressing the Impact of Carbon Footprint on Outsourced Activities: A Case Study On CRA Visits.” Summit for Clinical Ops Executives. February 13, 2024.
8 Crippa, M., et al. GHG emissions of all world countries — 2023. Luxembourg: Publications Office of the European Union. doi:10.2760/953322.
9 “Virgin Atlantic flies world’s first 100% Sustainable Aviation Fuel flight from London Heathrow to New York JFK.” Virgin Atlantic Airways LTD. November 28, 2023.
10 “Why go with Uber Green.” Uber Green – Sustainable Rides in Electric or Hybrid Vehicles on Uber
11 Data on File.
12 Assuming 18.5% reduction in emissions based on reduced CRA travel time
13 Data on file.
Filed Under: clinical trials, Drug Discovery, Regulatory affairs
