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Driving Sustainable Clinical Trials

The World Health Organization (WHO) considers climate change ‘the single biggest health threat facing humanity today’. Despite the crucial role of clinical trials in driving medical innovation and promoting evidence-based healthcare, they also pose a significant environmental impact. Based on previous studies, a 2021 study by Adshead et al. estimated the emissions of all 350,000 national and international clinical trials reported on ClinicalTrials.gov to be about 27.5 million tonnes of carbon dioxide (CO2) equivalent. More recently in 2023, another study by Mackillop et al. quantified the carbon footprint of three industry-sponsored late-stage cardiovascular, oncology and respiratory clinical trials, finding their total carbon footprint to range from 1437-2498 tonnes CO2e.

Although data on the environmental impact of clinical trials is still emerging, industry stakeholders, including sponsors and contract research organizations (CROs), agree that there is an urgent need to take measures to reduce their global carbon footprint. This shift towards eco-friendly methods is not only reducing the environmental impact of research but also improving patient access and trial efficiency. Here, we will explore how CROs in biotech and biopharma are driving sustainable practices in clinical trials.

Continue reading to discover the latest green innovations reshaping clinical research and how CROs like TFS HealthScience are setting new industry standards for sustainability.

 

Decentralized and Virtual Clinical Trials: Reducing Carbon Footprint

One of the most significant advancements promoting greater sustainability in clinical research is the adoption of virtual or decentralized clinical trials (DCTs). These study designs allow patients to participate in a clinical trial from the comfort of their homes while using mobile health technologies (i.e., wearables) that collect data throughout their daily life. Such trials have protocols that require less frequent on-site visits, which results in reduced greenhouse gas (GHG) emissions associated with patient travel to centralized research sites.

A 2024 sustainability report also notes an average clinical research associate (CRA) visit in North America can have an approximate carbon footprint of 500 kg of CO2e. Based on this estimate, decentralized and digitized study designs can help sponsors decrease their study’s total GHG emissions by requiring fewer in-person evaluative site visits by CRAs. Although more guidance is needed for sponsors executing and developing DCTs, virtual study designs are becoming an increasingly common practice for driving eco-friendly clinical trials.

 

Streamlining Clinical Trials with Digital Data Capture

Another approach worth highlighting is the shift from paper-based to digital data capture systems, which has revolutionized the way clinical trials are conducted since the introduction of remote data entry (RDE) software in the late 1980s. The advantages of digital data capture include greater efficiency in data analysis and improved data accuracy, as well as real-time data-driven insights into a clinical trial’s or participant’s progress, enabling faster decision-making.

In an analysis by Accenture and the World Economic Forum, scaling the adoption of digital technologies across several industries, including the clinical research industry, could reduce emissions by 20% by 2050 in the three highest-emitting sectors: energy, materials, and mobility. Accordingly, digitizing clinical trial data collection and storage enables sponsors to meet the study record retention requirements of the United States (U.S.) Food and Drug Administration (FDA) with less physical storage space. Digital data capture also has the potential to lower energy consumption by limiting redundant data entry and accelerate trial timelines by shortening the time needed for data processing.

Read more about how digital tools can positively combat climate change in this article.

 

Key Waste Reduction Strategies to Consider

Many CROs are implementing key strategies to minimize material waste created during clinical trials. These could include optimizing supply chain management to reduce the overproduction of trial medications, implementing recycling programs for trial materials (particularly electronic components of digital devices provided to sites and patients), as well as using eco-friendly packaging in drug shipments. For example, many manufacturing vendors have adopted the use of reusable, temperature-controlled packaging solutions such as the Credo Cube when delivering drugs to clinical research sites. With this method, site staff can return the empty shipment container back to the manufacturing facility, which can be reused rather than thrown out after a single use.

Other sustainability strategies CROs often adopt include relying on local supplies of drug products to reduce transportation-related GHG emissions and standardizing laboratory testing kits sent to sites for improved reusability. Many electronic patient-reported outcomes (ePRO) platforms have now also introduced digital apps to allow patients to transmit trial data through their personal smartphones, minimizing the need for new electronic devices.

Learn more about waste reduction strategies to achieve sustainable supply and use of medication in clinical trials from this published article.

 

The Importance of Patient Centricity in Improving Sustainability

Aside from direct strategies for creating sustainable clinical trials, sponsors and CROs can make a significant impact simply by accounting for patient needs and preferences. Although patient-centric approaches are not a new concept in the pharmaceutical industry, they are worth exploring when attempting to reduce the environmental impact of trials. Designing a protocol that is reasonably convenient for patients where possible can lead to improved study design, enhanced patient experiences, and increased trust and engagement. As a result, these strategies have the potential to boost efficiency in recruitment practices, reduce patient dropout rates, and minimize losses in time and resources dedicated by site staff to enrolling participants.

Furthermore, as discussed earlier, DCTs can reduce a trial’s carbon footprint by introducing more telemedicine-supported visits and wearable technology, both of which decrease CO2e emissions related to patient travel and in-person visits. Remote trials can also improve a study’s accessibility and broader generalizability by promoting the inclusion of patients from ethnic or racial minorities, rural regions, and other medically underrepresented communities.

 

How CROs are Driving Sustainability Practices in Clinical Trials

Many biopharma and biotech organizations are committed to reducing their carbon footprints in

alignment with the United Nations (UN) Paris Agreement. The Agreement is a legally binding international treaty that came into effect in 2016, with all signing nations agreeing to reduce their emissions, assist developing nations in their climate mitigation and adaptation efforts, and work towards a net-zero emissions world. Included in these efforts are the various strategies being employed by global CROs to adopt green innovations and eco-friendly methods to reduce GHG emissions within the healthcare sector.

 

Sustainability Practices Adopted by PPD®

As highlighted in their 2024 sustainability report here, PPD® (a subsidiary of Thermo Fisher Scientific) is committed to reducing Scope 1 and 2 greenhouse gas emissions by more than 50% by 2030 and to achieving net-zero emissions across the entire enterprise by 2050. This global CRO is approaching their goals by focusing on four pillars:

  1. Developing predictive models to estimate carbon emissions of a clinical trial prior to enrollment and provide insights into the largest sources of GHG emissions.
  2. Establishing carbon accounting practices to calculate the actual and approximate emissions from clinical studies and report them to sponsors.
  3. Use modeling and analysis to identify opportunities for reducing emissions and promote more sustainable designs in clinical trial protocols from the start.
  4. Collaborate with clinical trial stakeholders, from vendors and sponsors to patients and investigator sites, to increase awareness of the contributors to clinical study carbon footprints and to develop innovative solutions for minimizing those footprints.

 

TFS CRO’s Commitment to Social Responsibility and Sustainability

TFS HealthScience is another global CRO with an unwavering commitment to social responsibility and sustainability as a core value that can be seen in every aspect of their operations. The company is taking on a comprehensive approach to sustainability, encompassing environmental stewardship, social responsibility, and ethical governance:

  • Environmental Initiatives: TFS has implemented advanced CO2 emission tracking tools and invested in renewable energy sources within their Science Based Targets initiative (SBTi).
  • Social Responsibility: TFS fosters an inclusive workplace culture with high employee engagement scores and extensive training programs.
  • Ethical Governance: TFS maintains rigorous ethical business practices, emphasizing transparency, accountability, and a zero-tolerance stance on corruption to underscore their commitment to integrity.

Their dedication to sustainability practices can be seen in TFS’s consistent recognition from EcoVadis, the world’s leading provider of business sustainability ratings. The company has secured a Silver Rating for five consecutive years and is among the top 15% of 1.6 million companies evaluated globally.

Access the full details from the 2023 TFS Sustainability Report here.

Earlier this year, TFS also reported an improvement of its Carbon Disclosure Project (CDP) scoring from ‘D’ to ‘C,’ reflecting enhanced initiatives in managing environmental impact. The CDP, a global nonprofit, operates the world’s leading platform for environmental information disclosure. Additionally, TFS has committed to set science-based targets with the SBTi, further demonstrating a strong ambition to reduce the company’s carbon footprint and support global climate goals.

Read the full article here.

 

Conclusion

In conclusion, the clinical research industry is among many sectors recognizing the immediate need for more proactive innovations to reduce carbon emissions in the future. CROs like TFS and PPD are driving considerable sustainable practices in clinical trials, which are helping reduce the environmental impact of these studies, while promoting improvements in patient access, data quality, and overall trial efficiency. The increasing adoption of green practices within the biotech and biopharma industries is setting a new standard for responsible and sustainable clinical research, paving the way for significant reductions in GHG emissions within the healthcare sector.

 

About TFS HealthScience CRO

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey with a commitment to Social Responsibility and Sustainability. As a trusted CRO partner throughout the entire clinical development journey, we understand the importance of providing essential and diverse services to streamline clinical trials for our clients while promoting reduced carbon emissions. Visit our website to learn more about the solutions TFS can offer for your next clinical trial or connect with a TFS representative today!

Interested in learning more about TFS’s sustainability initiatives? Visit our page here.

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