Conducting Sustainable Clinical Trials- A step in the right direction

With the problems of climate change continuing to grow, the footprint of the pharmaceutical industry on the environment is under pressure for reduction. Clinical trials, as a major portion of drug development, do tend to hold a huge environmental footprint, taking into consideration the quantity of resources used, travel needs, and waste generation. However, there stands one way by which these impacts can be considerably reduced: digital technologies. This blog looks at traditional clinical trial environmental effects and how digital technologies can be harnessed in mitigating these problems, with some important statistics from recent studies.

Environmental Impact of Traditional Clinical Trials

Traditional clinical trials are resource-intensive and costly. They also have negative environmental impacts through their generation of carbon emissions, consumption of resources, and overall waste. Some key statistics from this include:

Carbon Emissions

1. Traditional clinical trials produce a lot of carbon emissions. A typical Phase III cancer trial creates about 15,000 metric tons of CO2 equivalents over three years.
2. In some trials, for example those on prostate cancer, 59% of total emissions are due to participant travel.

Paper Waste

1. A medium-sized clinical trial of 2,000 patients utilizes about 164,800 sheets of paper. That is the same as a stack over 16 m high resulting in 799 kg CO2 emissions.
2. This goes up further by 40 kg of CO2 for transportation of documents to monitors; it is, therefore, 4,885 kg with just monitoring and a paper-based trial.

Energy Consumption and Waste Generation

1. Clinical facilities consume a lot of energy for their running. It adds up to the greenhouse gas emitted.
2. During trials, hazardous and non-hazardous waste may be generated that could ultimately be used to harm the ecosystem if inappropriately disposed of.

Logistical Impact

1. A usual clinical trial will have five monitoring visits to the trial site. Each of these visits add to the carbon footprint of the trial.

Digital Technologies Mitigating Environmental Impact

Digital technologies offer sustainable solutions to reduce the environmental impact of clinical trials. These technologies will thus provide alternative methods for many conventional practices. The key technology interventions and their benefits are as follows:

Decentralized Clinical Trials (DCTs)

1. Through DCTs, patients can participate in clinical trials from their homes, greatly reducing related emissions. A fully digitalized clinical trial cuts down CO2 emissions by 90.1%, saving approximately 4,399 kg of CO2.
2. Implementing DCTs for the 15,000 clinical trials that start annually in Europe would save between 41,009 and 65,981 metric tons of CO2 every year.

Remote Monitoring and Data Collection

1. Remote monitoring through the cloud-based platforms and wearable devices in general can cut site visits by up to 30%, saving time and resources.
2. Moving to digital data capture has reduced our paper use by almost 70%, greatly diminishing our waste and our use of resources.

Artificial Intelligence (AI) and Machine Learning

1. It helps with determining suitable locations and recruiting patients, reducing the number of unwanted trials and their associated carbon footprints. In reality, AI has prevented setting up 30% of clinical trial sites where patient recruitment fails.
2. AI-driven data analytics enable focused monitoring and efficient use of resources in trials, which reduces related emissions.

Supply Chain Optimization

1. Interactive Response Technologies (IRTs) allow real-time management of the supply chain and the reduction of waste from overproductions and unnecessary shipments; in fact, drug wastage can be cut by 15% through such optimizations.

Electronic Data Capture and eConsent

1. Moving from paper to electronic systems of capturing data reduces the carbon footprint associated with document production and storage. It can eliminate up to 90% of the emissions created, which is equivalent to a carbon offset from 237 trees growing for one year.
2. Electronic consent forms (eConsent) facilitate the enrollment: less paperwork, less paper wastage, and more convenient for the participant.

Wearable Technologies and Real-Time Data

1. Wearable devices and sensors now allow for continuous monitoring, real-time data collection, and a substantial reduction in site visitation.
2. By 2025, 70% of all clinical trials will use wearable sensors, and collected data will be of higher quality and reliability, with decreased environmental impact.

Telemedicine

1. Telemedicine will reduce the number of visits to clinical trial sites and, hence, travel-related emissions by orders of magnitude, potentially translating into CO2 reductions of several hundred metric tonnes per trial.

Industry Initiatives and Commitments

The pharmaceutical industry is moving on different measures and commitments in the direction of sustainability, which are:

1. The Pistoia Alliance has created standards for calculating the environmental impact of clinical trials. These standards enable comparisons between site-based and decentralized trials.
2. Many pharmaceutical companies have appointed Chief Sustainability Officers (CSOs) to lead sustainability efforts. They have committed to ambitious goals, such as achieving carbon-neutral or carbon-negative operations by 2030.

The adoption of digital technologies in clinical trials is essential for reducing their environmental impact. By using decentralized trials, AI, and remote monitoring, the industry can significantly cut carbon emissions, resource use, and waste. As the pharmaceutical industry continues to innovate and tackle environmental challenges, digital solutions have the potential to revolutionize clinical research. They can make it more sustainable and environmentally friendly.

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Sources:

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10597501/ https://www.nature.com/articles/s41746-023-00841-8
2. https://neptjournal.com/upload-images/(36)B-4045.pdf
3. https://www.iqvia.com/-/media/iqvia/pdfs/library/presentations/sustainability_in_clinical_trials_act_0624.pdf
4. https://pharmaphorum.com/rd/how-are-clinical-trials-becoming-more-environmentally-friendly
5. https://www.degruyter.com/document/doi/10.1515/cclm-2022-1092/html?lang=en
6. https://www.appliedclinicaltrialsonline.com/view/sustainability-in-clinical-trials-purposeful-digitalization-is-key
7. https://www.fieldfisher.com/en/insights/sustainability-a-new-era-in-clinical-trials