By Ed Miseta, Chief Editor, Clinical Leader
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As we come to the end of 2020, the world remains focused on finding a vaccine that is effective at halting the spread of COVID-19. The pandemic is already responsible for the deaths of over 1 million people worldwide. In 2020 it also resulted in the cancelling or delay of numerous non-COVID trials for other important medications.
The virus has certainly had an impact on drug development. At the peak of the pandemic, COVID vaccines and treatments accounted for 30 percent of all trials in the U.S. This resulted in hundreds of trials related to other diseases to be put on hold. To get pipelines back on track, companies have taken up a virtual research model. Right now, oncology and CNS trials are the only ones expected to fully recover by the end of Q3 2020. With a new wave of COVID infections sweeping both the U.S. and the world, a return to normal for clinical trials seems as if it will be further delayed.
I spoke to Steve Kemler, director and life sciences senior analyst with consulting firm RSM US LLP to understand how trials were impacted in 2020 and what we can expect in 2021.
Ed Miseta: Looking back on 2020, what do you think was the most significant impact that COVID-19 had on clinical trials?
Steve Kemler: The pandemic had an immediate impact on patient enrollment in active trials, prevented patients from attending follow-up visits in person, and resulted in many trials being put on hold. New trials were difficult to start at that time for the same reasons. However, the life sciences industry immediately pivoted to investigating therapies and vaccines for COVID-19. According to an analysis by RSM and Scientist.com, at points over the summer, between 20 percent and 30 percent of all new trials starting each week were related to the pandemic.
Miseta: Will the pandemic continue to impact trials into the new year?
Kemler: Unfortunately, in the United States, the pandemic is currently getting worse and not improving. Looking at data from Medidata, we can see that most indications showed slowly improving trial enrollment numbers over the summer, but this dropped off again as we entered the fall and case counts increased. Although people will not be able to put off healthcare and elective procedures indefinitely, it is difficult to enroll new patients in trials if they are postponing healthcare. Outside the U.S., the environment varies greatly by country and there are opportunities for CROs and sponsor companies to adjust the geographic mix of sites to match.
Miseta: Did sponsor companies react well to the pandemic and the impact it had on their clinical trials?
Kemler: We talk to a lot of leaders of CROs, pharma companies, and biotech firms. All of them have responded to the crises as well as they could. They have done this with frustratingly limited information, all while trying to balance the safety of their employees, the stability of their business, and the unmet patient needs that led them to start these companies in the first place. The fact that most studies have restarted, and new studies are initiating, even if in a smaller volume than last year, is a testament to the resilience of life sciences companies and CROs.
Miseta: When the pandemic began to impact the U.S. in March, what one technology was most vital to allowing companies to continue to collect data from their patients?
Kemler: One of the biggest changes seems to have been the switch to remote site monitoring and using telehealth for patient monitoring. This reflects the broader shift within healthcare to leveraging telehealth to continue treating patients that were not comfortable or able to return to physicians’ offices. In April, outpatient physician visits were down 60 percent compared to before the start of the pandemic, according to a report by The Commonwealth Fund. Telemedicine quickly increased as a percent of all visits and has become a much more important component of how we deliver health, including clinical trials.
Miseta: Did CROs play a significant role in helping sponsors and sites to be able to continue to care for patients enrolled in their studies?
Kemler: Absolutely. CROs have been innovating on how we deliver studies, recruit patients, and deliver care as part of studies for some time. Many of them had already built out powerful tools to support virtual trials, hybrid trials, and remote site monitoring. So, they were ready to quickly help sponsors pivot to this new environment and leverage those tools. One challenge is that trials that were designed to be delivered with a traditional site-based approach have limitations in their design that make it difficult, if not impossible, to transition to a fully virtual trial.
Miseta: You believe oncology and CNS trials are likely to be the only ones that fully recover by the end of Q3 2020. What advantage did those trials have over others?
Kemler: The unfortunate truth with CNS and oncology trials is that patients are not able or willing to put off care for long, despite the pandemic. So, they saw an initial drop in enrollments and starts but have been quicker to recover. We expect that to continue and for these trials to be less sensitive to any increases in infection rates than other indications.
Miseta: Are the virtual components that sponsor companies incorporated into their trials in 2020 likely to be a part of trials in the future?
Kemler: Yes, many of these changes are here to stay. Telehealth and virtual trials make participating in trials easier for patients and 2020 has forced sponsors to adopt solutions that they may have been hesitant to try in the past. Now, they see that they work, that they do not increase the risk of their trial, and that they offer advantages and flexibility that traditionally structured trials do not have.
Miseta: What advice do you have for sponsor companies in preparing their clinical trials for the next pandemic?
Kemler: We have a tendency to assume that our future challenges are going to be similar to our current or past challenges. As we are painfully learning this year, that is not a safe assumption. All life sciences companies can do is build flexibility and resiliency into their teams and their trials. They should build strong relationships with their CROs and other key partners to ensure their teams are prepared to work together to find a path forward in times of crises. Finally, they should think critically about how they are designing their trials and consider whether they are doing things because that is the way they have always done them, or if they are adopting new technologies and designs that will provide them additional flexibility.