Climate change has become a joke in the post pandemic world, especially inside Clinical Research Organization. Being the epicentre for care delivery, CROs need to be more sensitive about the climate change than before. But research reveals the very opposite.
Did you know that the healthcare industry is responsible for a significant portion of global carbon emissions? According to the Intergovernmental Panel on Climate Change (IPCC), healthcare accounts for approximately 4.4% of all emissions worldwide. One healthcare sector that has come under particular scrutiny is the pharmaceutical industry, which is responsible for generating a significant amount of waste, including clinicaltrial and pharmaceutical’s industrial waste. Adding to this list is improper disposal of hazardous waste. This leads to severe environmental consequences, demanding the need for sustainable practices in the healthcare industry.
But, few healthcare leaders believe that this narrative should be changed. They are riding the wheels of change by adhering to sustainable practices. From reducing energy consumption in healthcare facilities to properly managing hazardous waste, care professionals are taking action to mitigate their impact on the environment.
So how are healthcare professionals managing growth and development while also implementing sustainable practices?
Join us as we explore the world of sustainability in healthcare and clinical trials. We’ll take a deep dive into the various measures and practices that are being implemented to promote a more sustainable future for the healthcare industry.
Health Equity: Inclusion of Clinical Trial Diversity Clinical trials, at its fundamental core, is about enhancing care delivery, across all geographies, especially inclusion of underrepresented communities. This makes it highly significant that CROs need to ensure that any clinical trial has equal participation from patients of all communities. This not helps to study a particular ailment and its impact across various geographies but also helps to facilitate a solution for any health disorder that may impact differently to different communities.
For instance, if a clinical trial that aims at drug discovery for a communicable disease, only includes white or black; European or Asian community and is not inclusive of all the communities, scientists may end up investing large chunk of investment solving only one portion of the problem. But, today, communities are not defined by geography. In the globalized world, communities are intertwined but on the genetic front, a treatment for population of white hierarchy may not be suitable for Asian or African community.
This leads to the necessity of inclusion of clinical trials for all racial and ethnic population.
Fortunately, there are several steps implemented in this direction by FDA, USA.Few are listed below:
- In 2019, the FDA issued draft guidance aimed at improving the diversity of participants in clinical trials. This guidance was finalized in November 2020.
- In 2018, the MRCT Center Diversity Workgroup was formed by Brigham and Women’s Hospital and Harvard, which published a guidance document in 2020 and a toolkit in early 2021. Additionally, the Pharmaceutical Research and Manufacturers of America (PhRMA) and its member companies released industry-wide principles on clinical trial diversity in November 2020, which took effect in April 2021.
- In 2020, the American Medical Association partnered with the All of Us program to gain better insights into disease prevention and treatment.
- Finally, the National Academies of Sciences, Engineering, and Medicine published a report titled “Strategies for ensuring diversity, inclusion, and meaningful participation in clinical trials.”
- Carbon Footprint: A Major Climate Crisis
Clinical trials are an essential part of drug development and are crucial to ensuring the safety and efficacy of new drugs before they are made available to the public. However, there has been a growing awareness of the need to incorporate sustainability practices in clinical trials to reduce their environmental impact. According to a study published in the Journal of Cleaner Production, the carbon footprint of clinical trials in the United Kingdom alone was estimated to be 179,000 tonnes of CO2e per year, which is equivalent to the annual emissions of over 37,000 cars. This highlights the significant environmental impact of clinical trials and the need to reduce their carbon footprint.
The study also found that the most significant contributor to the carbon footprint of clinical trials was related to patient travel, accounting for 68% of the total emissions. This suggests that reducing patient travel through the use of virtual trial methods and patient-centric trial designs could significantly reduce the carbon footprint of clinical trials.
- Decentralized Monitoring: A 360° Solution to Climate Crisis
In response to suggestive trial design, the practice of sustainability in clinical trials has emerged. This involves taking into consideration the social, economic, and environmental impact of clinical trials, including reducing energy and resource consumption during the trial process and minimizing the amount of waste generated. By doing so, the drug development process can become more sustainable and contribute to the overall goal of achieving a more sustainable healthcare system.
Additionally, studies have shown that, decentralized monitoring methods are becoming increasingly popular in clinical trials, as they offer several advantages over traditional site-based monitoring. Decentralized monitoring involves using remote technologies to monitor trial activities, rather than relying on physical site visits.
Some benefits of decentralized monitoring include:
- Reduced Travel-related Emissions: Since decentralized monitoring does not require physical site visits, there is a significant reduction in travel-related emissions. This can help inminimizing the carbon footprint of a clinical trial and reduce its environmental impact.
- Increased Efficiency: This practicecan be more efficient than traditional monitoring methods, as it allows for real-time data analysis and monitoring. This means that any issues or discrepancies can be identified and addressed quickly, reducing the risk of delays or errors.
- Cost Savings: Budget is a primary concern when dealing with clinical trial. Decentralized monitoring solves it by beingless expensive than traditional monitoring methods, as it eliminates the need for travel and on-site monitoring resources. This can help to reduce the overall cost of a clinical trial, making it more accessible and affordable.
- Improved Patient Experience: Decentralized monitoring can help to improve the patient experience, as it reduces the need for patients to travel to trial sites for monitoring visits. This can help to minimize the burden on patients and improve overall patient satisfaction.
Overall, decentralized monitoring methods offer several benefits for clinical trials, including reduced travel-related emissions, increased efficiency, cost savings, and improved patient experience. Incorporating these methods into clinical trial design can help to promote sustainability and reduce the environmental impact of clinical research.
Furthermore, the disposal of clinical trial waste can also have a significant environmental impact. By implementing waste reduction and recycling programs, the amount of waste generated by clinical trials can be minimized. This can include the recycling of packaging materials, reducing the use of disposable items, and implementing appropriate disposal methods for hazardous waste.
Are Global Laws pro-sustainability? Check it out!Sustainability is the only solution. But, should not be only reserved up to speeches in global forums and international summits. To take that first leap, government and legal institutions have legislated various laws for public and private CRO. Implementing These laws and acts aim to promote sustainable practices and ensure that healthcare facilities and services are accessible to all.
Hospital Survey and Construction Act, also known as the Hill-Burton Act, a federal law, enacted in 1946, provides funding for the construction and modernization of hospitals and other healthcare facilities, with the goal of making healthcare services accessible to all individuals. As part of the act, healthcare facilities are required to provide a reasonable amount of free or reduced-cost healthcare services to those who cannot afford to pay.
Hill-Burton Act also requires healthcare facilities to prioritize the use of energy-efficient technologies and sustainable building materials in their construction and renovation projects. This not only reduces the environmental impact of healthcare facilities but also leads to long-term cost savings through reduced energy consumption and maintenance costs.
The Environmental Protection Agency’s (EPA) Clean Air Actwas first passed in 1963 and later amended in 1990, aims to reduce air pollution and improve air quality. The Clean Air Act applies to all industries, including the pharmaceutical industry, and requires companies to adhere to strict emissions standards and implement pollution control measures.
In addition, the EPA also regulates the disposal of hazardous waste, including pharmaceutical waste generated by clinical trials. Pharmaceutical companies are required to follow strict guidelines for the disposal of hazardous waste, including the use of specialized disposal methods and the implementation of waste reduction and recycling programs.
Beyond government laws and acts, many Transnational Organizations and international institutions have also implemented sustainability practices in clinical trials. The World Health Organization’s Good Clinical Practice guidelines, for example, emphasize the importance of ethical and sustainable practices in clinical trials. This includes the responsible use of resources, the reduction of waste generation, and the implementation of sustainable trial designs.
Similarly, the Green Clinical Trials Initiative, launched by the University of California, San Francisco, aims to promote sustainable practices in clinical trials. The initiative provides resources and guidance for researchers to incorporate sustainability practices into their trial designs, including the use of virtual trial methods, the reduction of patient travel, and the implementation of waste reduction and recycling programs.
Wrapping Up
The growing acknowledegement of sustainability practices in clinical trials are driven by a desire to reduce the environmental hazards of pharmaceutical industry address the challenges of climate change. Efforts to incorporate sustainability into clinical trials are ongoing, and there is still much work to be done. However, there are a variety of tools and resources available to support this work, including sustainability frameworks and guidelines, as well as innovative trial designs and technologies. In conclusion, incorporating sustainability practices in clinical trials not only aligns with government and institutional laws and acts but also promotes ethical and responsible practices in drug development.Moving forward, it will be important to continue to prioritize sustainability in clinical trials and work collaboratively to develop and implement more sustainable practices. This will require engagement from all stakeholders involved in clinical trial design and management, including researchers, institutions, regulators, and patients.
Ultimately, by prioritizing sustainability in clinical trials, we can work towards a more sustainable and equitable future, reducing the environmental impact of the pharmaceutical industry and contributing to a healthier planet for all.
References:
World Health Organization. (2017). Sustainable health financing, universal coverage and social health insurance. https://www.who.int/health_financing/topics/financial-protection/health-insurance/en/
United Nations. (2015). Transforming our world: The 2030 Agenda for Sustainable Development. https://sustainabledevelopment.un.org/post2015/transformingourworld
U.S. Environmental Protection Agency. (2019). Hazardous Waste. https://www.epa.gov/hw
Clinical Trials Transformation Initiative. (2020). Environmental Sustainability in Clinical Trials. https://www.ctti-clinicaltrials.org/projects/sustainability
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
European Medicines Agency. (2018). Reflection Paper on the Need for Active Substance Master Files (ASMFs) for Synthetic Peptides. https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-need-active-substance-master-files-asmfs-synthetic-peptides_en.pdf
