Aligning Patient Burden with Planetary Burden

Michael Cohen, Senior Director, Lead, Environmental Sustainability

Robyn Owens, Manager, Recruitment and Engagement

Both with the PPD clinical research business of Thermo Fisher Scientific

Americans spend on average 38 minutes driving to the doctor for routine medical care¹ or approximately 20 miles round trip. Yet for clinical studies, we require our patients to sit in their cars for more than seven times as long for an average round trip of 134 miles. And rare disease patients experience even more travel, up to approximately 270 miles (albeit perhaps more likely in airplanes).²

This significant discrepancy between routine medical care and clinical trial visits highlights the fact that travel is a “key barrier to recruitment and retention…[and] may [even] be a bigger problem than previously thought.”² This should sound a warning bell for clinical trial operations experts as we already know that distance traveled to the site is a key driver in a patient’s decision to join a clinical study. Patients have told us that the maximum distance that they want to travel to a clinical trial site is 80 miles round trip.³ So why do we expect patients to travel so much further for a clinical study? How is this negatively impacting our patients, and further, how is it impacting the planet? What is the effect of clinical trial patient visits annually around the world?

Let us take the more than 350,000 registered interventional studies on ClinicalTrials.gov.⁴ If we conservatively assume 200 patients per trial with only 10 visits annually, that is about 37 million global patient visits per year.

Based on literature data, our clinical trial patients are spending more than an extra hour round trip to travel to clinical investigative sites compared to the distance they drive for routine medical care. These extra miles compared to the routine medical care visits result in the emission of about 21 megatons of greenhouse gases. This is the same volume of emissions as 3.6 coal-fired power plants annually, or one million American households. That’s just due to our patients driving further to clinical trial sites than they would to their doctor’s office.

As we consider this fact, it is critical to realize the patient and planetary toll. We already know the immense difficulties of recruiting and retaining patients in clinical trials, while literature, experience, and everyday common sense tells us that the further a patient must drive for a clinical trial visit, the less likely they are to join and stay in a clinical study.

Consider a few potential strategies to reduce patient burden, planetary burden, or both in relation to travel to clinical trial sites:

• Evaluate virtual or remote visits as a substitute for onsite visits whenever possible. This would involve telemedicine technologies and remote monitoring tools to reduce the need for the physical visit and transportation to the site. Further, leveraging digital technology via eConsent and electronic clinical outcome assessment/eDiaries can significantly reduce paper usage while simultaneously reducing site burden.
• Use home healthcare agencies that utilize technology for efficient routing, as well as electric vehicle (EV) or hybrid vehicles.
• The utilization of wearables with remote monitoring capability by the clinical trial sites helps reduce the need for in-person patient visits, thus reducing the carbon footprint.
• Incorporate lower impact transportation. Encourage and compensate participants for using more environmentally friendly modes of transportation (i.e., walking, public transportation, EVs, or cycling, assuming they are a true option based on geography).
• Work closely with a travel partner that can use more environmentally friendly modes of transportation and housing for patients. Working with vendors that have contracts with car companies that provide EV vehicles to transport patients to and from their site visits.
• If hotel stays are required, consider booking a hotel that is more environmentally friendly. A hotel in close proximity to the site that uses renewable energy and energy efficient lighting, heating, and cooling systems. Consider a hospital or medical facility that has a hotel nearby.

Let us consider clinical trials located near the patients to minimize travel distances. Accelerated Enrollment Solutions (AES), a business of PPD, has clinical trial sites across the US and Europe. These sites are strategically located in close proximity to demographically diverse patient populations. Using a sample of 400 paid for rideshare rides in the US between June 2022 and 2023, we found that patient visits averaged 31 miles per round trip, significantly lower than the values noted earlier. While we are not yet eclipsing the 20-mile round trip that the average American travels to go to their doctor, it is certainly a step in the right direction.

We find that on every trip we are saving about 28 kg of greenhouse gases per visit.5 (On a side note, AES is also planting a tree through its One Patient One Tree program for every patient who enrolls in a clinical trial at an AES site. To date, the business has planted more than 14,000 trees through that program.)

Our thesis is twofold. One is that patient burden and planetary burden are both interconnected. On our path toward researching new medicines and life-saving treatments, we must not unnecessarily contribute to anthropogenic climate change. Ever-increasing levels of greenhouse gases will have immense health impacts globally.⁶

The second is that our patients’ experience in clinical studies should be as adjacent to their typical medical experience as possible, which includes each individual’s commute.

This is why we continue to advance the use of digital technologies to expand virtual visits, enable local pharmacies, retail clinics, and mobile clinical trial units to support clinical studies with convenient locations,⁷ and advance the use of EVs and other strategies to encourage more environmentally responsible patient travel to clinical trial sites.

Michael Cohen, MSc, MBA, is Senior Director, Lead, Environmental Sustainability; and Robyn Owens is Manager, Recruitment and Engagement; both with the PPD clinical research business of Thermo Fisher Scientific

References

1. American Time Use Survey. US Bureau of Labor Statistics. 2023. https://www.bls.gov/tus/

2. Taylor, N. Clinical Trial Participants Travel 67 Miles to Study Sites on Average, Analysis Finds. Outsourcing-Pharma. November 9, 2022. https://www.outsourcing-pharma.com/Article/2022/11/09/clinical-trial-participants-travel-67-miles-to-study-sites-on-average-analysis-finds#

3. Fakhoury, A. The Methods and Results of Creating a Patient Burden Algorithm. SCOPE. 2021. https://www.scopesummit.com/21/Site-Selection

4. Trends and Charts on Registered Studies. ClinicalTrials.gov. https://clinicaltrials.gov/about-site/trends-charts

5. Greenhouse Gas Equivalencies Calculator. US EPA. January 2024. https://www.epa.gov/energy/greenhouse-gas-equivalencies-calculator

6. Climate Change and Human Health. US EPA. March 14, 2024. https://www.epa.gov/climateimpacts/climate-change-and-human-health#:~:text=The%20health%20effects%20of%20climate,and%20overall%20poor%20mental%20health

7. Alsumidaie, M. The Role of Retail Pharmacies in the Evolving Landscape of Clinical Research. Applied Clinical Trials. March 7, 2023. https://www.appliedclinicaltrialsonline.com/view/the-role-of-retail-pharmacies-in-the-evolving-landscape-of-clinical-research