According to the survey, while the industry experienced a dip in new patient participant enrollment in the second quarter of 2020, recent data indicates that enrollment is headed back uphill.
Outsourcing-Pharma (OSP) recently examined the trends with Kyle Cunningham (KC), chief product officer of Greenphire, and what might transpire in coming months.
OSP: Could you please provide an overview of how the pandemic’s impact?
KC: The COVID-19 pandemic shook not only the world, but also the clinical trial industry.
Given the spread from the far East to the West, the initial impact of declining clinical trial enrollment was felt first in Asia and then Europe, followed by the United States in early 2020.
If we reflect on patient enrollment data sourced from Greenphire’s payment platforms, global enrollment hit a trough in April 2020. Given the scale of Greenphire’s clinical trial experience, we see this as a microcosm of the health of the broader industry; via ClinCard, we’ve supported more than 2m patients and more than 9m participant payments as of June 2020)
Separately, Greenphire surveyed global sponsors and CROs and 71% reported that they had paused new study enrollment. Additionally 58% had suspended or delayed new study starts.
However, the industry has found a way to transform services to meet patient and sites where they are. As a result, Greenphire payment data now shows that global patient enrollment has returned to pre-COVID-19 levels.
It’s important to note that it’s not just the influx of COVID-19 treatments that are inflating these numbers. We’ve extracted that information as to demonstrate just how robust the current patient enrollment data is without those mega-studies skewing results.
OSP: Please share what you feel are some of the reasons behind the rebound.
KC: Some of the reasons for this rebound are:
- Resiliency of sites—sites found a way to meet patients where they are. Early in the pandemic, we heard that sites immediately took to visiting patients in their homes, in their clinic parking lots or via the phone. They are committed to keeping clinical trials viable no matter what.
- Recognizing the resiliency of sites, sponsors acted, and acted swiftly. They heeded the guidance of the FDA and EMA to evaluate alternative methods for safety and efficacy assessments, specifically changing physical visits into phone or video visits or providing for alternate locations for assessments.
- Service providers, such as Greenphire, quickly pivoted services to provide direct-to-patient technology tools. One such example will be discussed in an upcoming webinar with Signant Health: https://bit.ly/3kWjeVw. In our experience, many are using “decentralized trials” as the new industry buzzword. Our goal is to ensure that sponsors, CROs and sites know exactly what tools are available to support both in-clinic and hybrid trial environments, and also how those tools can best integrate across the patient experience.
OSP: Could you please tell us some of the highlights from the Greenphire survey, especially anything you might have found surprising?
KC: 83% of those surveyed said that removing financial and logistical barriers that could deter patients from participating in clinical trials is more important now than it was before the COVID-19 pandemic. Responders from outside of the US responded the same way – so this isn’t a US phenomenon / sentiment (82%)
OSP: What are the key takeaways and lessons trial professionals might learn from the survey findings?
KC: They are:
- Find ways to be flexible in helping site personal to support patients wherever they are – whether that’s in (and getting to the clinic), at a local lab, or in their home using remote technology tools.
- The speed in which the industry responded to the COVID-19 pandemic has been impressive. Time will tell if the pace of technology usage will continue, but as with other digital transformations, once a new way of doing something has been explored and tested, there’s generally no going back. Look for more hybrid technology to be used in the future.
- Sponsors and CROs today are looking to budget these tools so they are implemented in a cost-effective, globally-transparent way – namely through enterprise adoption of technology.
- Sponsors and CROs should look to technology and service providers to offer best practices on these tools as well as training, so sites understand the value and realize the ROI of these investments.