How are clinical trials becoming more environmentally friendly?
While patient centricity remains vital to the life sciences industry, as companies come under pressure to reduce their carbon footprint, we are increasingly seeing different aspects of the industry becoming greener and sustainability is seeing greater prioritisation.
Part of what’s driving this change is that in the highly competitive environment of modern pharma, strong green credentials can provide a competitive edge. But for the most part, I think the change is happening because many who work in the pharmaceutical industry have an innate desire to make the world a better place.
Most large pharma companies now have a chief sustainably officer (CSO) whose role is to implement technologies, operations, and policies in order to reduce company carbon footprints. While manufacturing and waste disposal have typically been identified by CSOs as the main areas where emissions can be slashed, there are also many aspects of clinical trials that are becoming more environmentally friendly – without sacrificing the patient experience or data quality.
The role of decentralised clinical trials
Digital technologies are now being used more than ever to help decentralise clinical trials. This is making them more accessible, efficient, and environmentally friendly.
Decentralised clinical trials (DCTs) are studies in which some or all of the activities typically conducted at an investigator study site can occur outside of the site, most commonly at a patient’s home. DCTs focus on bringing the trial directly to the patient; data collection is completed in the home or community, independent of geography. DCTs have an obvious benefit in allowing patients to do as much of the trial from the comfort of their own home, improving the patient experience as the trial fits into their lives, instead of them fitting into the trial. This has the added benefit of reducing the need for travel time.
Travelling to the study site is a substantial factor in carbon emissions produced from clinical trials: the average individual travels over two hours for each visit to a clinical trial site. Therefore, if we can use technology to reduce visits, this has a knock-on effect in reducing emissions. Video visits, eConsent, remote data collection, and monitoring are examples of technology that help realise DCTs. To make these activities even greener, clinical trials are increasingly encouraging patients to use their own phone or tablet to submit data electronically. Using the patients’ own devices reduces the need to create and ship new devices for every study and individual participant, which adds up to create a lot of waste.
Technology in clinical trials offers another advantage to the environment that is perhaps less obvious: it allows sponsors and contract research organisations (CROs) to monitor the decentralised clinical trial or the physical trial site from their office, therefore reducing the number of site visits. The same effect discussed with lowering emissions through reducing patient travel applies to CROs’ travel too.
In DCTs, the use of video visits, e-diaries, sensors, and wearables mean a lot of data is collected in real time. The constant monitoring using technology allows CROs to look for outliers in the data. This creates a continuous direct conversation between sponsors, CROs, patients, and clinical trial sites. For example, a patient could be wearing a sensor that shows a spike in temperature that is recorded in real time, so the patient can be followed up with immediately. Spotting outliers in the data early reduces the need for patients to continue for the duration of a trial unnecessarily or waiting for them to call in to report an adverse event. This has a waterfall effect: by taking better care of patients and by making quick decisions through real time monitoring, the industry is saving energy by limiting waste on superfluous resources and time spent.
Artificial Intelligence has a role to play
We are seeing artificial intelligence (AI) shake up the wider healthcare industry – and this is no different in clinical trials, where AI is bringing significant efficiency benefits and hence a positive impact on CO2 emissions. For example, site feasibility is a crucial part of the clinical trial process, and getting this right prevents a huge amount of wasted time, energy, and resources. It is hard to believe, but 20-30% of clinical trial sites that are set up never actually recruit a patient. AI solutions are now being used by the industry to identify a site that will recruit patients in a particular indication quickly and get good quality data earlier. By using AI to prevent the needless set up of clinical trial sites which then fail, we remove the carbon footprint associated with the set-up of facilities, training, materials, and travel that are all part of the process.
Going even further, what if you could reduce the number of sites by 50% or more? Synthetic control arms or a ‘virtual twin’ provide a solution, where data from past participants is utilised as the placebo arm in a clinical trial, removing the need to enrol that population. Not only is the solution patient friendly, as all participants are getting an active drug, but once again the reduced number of patients in trials and cutbacks on manufacturing ultimately reduce the carbon footprint.
Clinical trial researchers have historically recorded and transferred all data in hard copies, either on paper or on physical digital media devices. The journey from starting the clinical trial and collecting data right through to the end of study media all has to be recorded – which produces giant crates of paper that have to be stored in a warehouse or transported across the world. Building and maintaining storage facilities, as well as paper manufacturing and shipping of records burns a lot of energy. Solutions now exist that offer remote data management systems, so clinical trial data can be entered directly into the computer, allowing pharmaceutical companies and clinicians to share that data remotely. Not only is it quicker, and arguably more compliant, as hard copies can get lost, but it also has a massive impact on reducing tonnes of carbon every year.
Striking a balance between being patient-centric and being environmentally centric
It is great to see a drive from the pharmaceutical industry to adopt solutions that are lowering its carbon footprint. However, it is important to strike a happy medium to ensure trials are both patient-centric and environmentally sustainable. While the greenest approach would be to for all patients to utilise their own phones and have an entirely virtual clinical trial, this wouldn’t be convenient for many patients who don’t have access to or feel comfortable using technology. We are already making great progress in making clinical trials more sustainable and, while there is still work to do, I am excited to see how the industry continues to find ways to be greener, while keeping standards high for patients and providing them with choices to help ensure optimised experiences.