Managing the COVID-19 pandemic has prompted countries and regions around the world to introduce a series of adaptions. For the most part, business as usual is underway, but some areas of life are still heavily impacted. One of the most significant issues for clinical research is patient recruitment and subject participation.
The Slow Road Out of Lockdown
Since March 2020, over 500 companies have announced that clinical trials were disrupted because of COVID-19 restrictions. While most of these issues stemmed from lockdown requirements and investigators’ availability, many studies have been able to resume normal functioning with some adaptions. However, the road out of lockdown is a slow one.
Trials have had to introduce additional safety measures to protect subjects, which has added to the cost of study operations. Additional personal protection equipment (PPE) is necessary, as well as extra costs for cleaning materials, travel for patients, and other precautionary measures. There are also unexpected costs for alternative monitoring strategies and technologies to enable virtual visits or data collection. Furthermore, in cases where resources are limited, such as investigator time, the priority is centered on COVID-19 trials or the care of COVID-19 patients. There simply isn’t enough time or resources to go around.
Challenges in Restarting Clinical Trials
While eventually, these realities will become embedded into study costs, there is undoubtedly a bottleneck. Roughly 1,000 trials related to COVID-19 therapies or vaccines popped up almost overnight as companies, governments, and other organizations rushed to develop treatments and medical countermeasures (MCM) for the virus. Most of these studies will move from the final protocol to the first patient visit in less than a month, whereas before the pandemic, it would have taken closer to six months to reach that point.
That fact is a wonderful thing for COVID-19 research and the people impacted by the pandemic, but what about the studies that had been put on hold or postponed as a result of the pandemic?
Also, what will it mean for existing study protocols if subjects come back to studies sicker than they were before because their condition progressed without intervention? Many patients missed screenings or put off appointments because of fear of contagion. Telehealth solutions resolved some of those concerns, but not everything can be done at home. Further, what impact does it have on study data if a participant caught COVID-19?
Adapting to a New Normal
Researchers have put in place many COVID-19, and many trials are rebounding. In April, US trial sites saw enrollment down 70%; by June, new subject enrollment in clinical trials was down 38% in the United States – dismal numbers but still a substantial improvement. At the end of July, most studies had reopened, and there was a return to baseline enrollment rates around the world – just in time for new lockdowns as a second wave began to hit toward the end of 2020.
This time around, the impact on study enrollment was minimized. Researchers put in place a series of adaptions that they learned from the first time around adaptions. However, convincing patients to enroll in studies during the age of COVID-19 is another matter.
Enrolling Patients in a COVID World
According to the New England Journal of Medicine, over 3 million people in the US have had COVID-19, and very few of them have joined a clinical trial: “If every study registered on clinicaltrials.gov as of mid-June meets its target enrollment, less than 4% of those diagnosed with Covid-19 will have been enrolled in a randomized, controlled trial.”
The problem is two-fold. On the one hand, there is the issue of resources – that includes money as well as investigators, staff, and room at research sites. The other is that the competition for patients is intense. There could be eight or more clinical trials wanting to enroll from the same patient population on any given day.
Clinical Trial Competition
Clinical trials effectively have to compete for qualified subjects. Contract research organizations (CROs) with experience working in different geographic areas may have the key. They have to find new ways to reach patients outside of the traditional pathway via primary care physicians (PCPs). After all, roughly 45% of all millennials do not have a PCP. The adoption of decentralized trials, which may require less burden to patients, can also help make participation more convenient, but that is just a beginning.
At Allucent, we have found that it takes a series of different methods working in concert to be productive in clinical research during a pandemic.
SOURCES
- ACCENTURE: COVID-19: 5 new human truths that experiences need to address
- ACRP: Considering the Realities of Restarting Trials Post-COVID-19
- APS (use for quotes): Human Behavior in the Time of COVID-19: Learning from Psychological Science
- CRITICAL TRIALS ARENA: Clinical trials disrupted due to Covid-19 slowly resume
- KHN: Spurred By Convenience, Millennials Often Spurn The ‘Family Doctor’ Model
- NATURE: Covid-19 and Human Behavior
- NATURE: Ten considerations for effectively managing the COVID-19 transition
- NEJM: Improving Clinical Trial Enrollment — In the Covid-19 Era and Beyond
- SCIENCE: Clinical trials rebound after the COVID-19 crash, but can enrollment gains continue?
- STAT NEWS: There’s a silent crisis in clinical research. And it’s not Covid-19
- STAT NEWS: With Covid-19 halting clinical trials, wearables could be key — but data’ wild west’ gets in the way
- SURVIVOR NET: Nearly 40% of Cancer Clinical Trials Disrupted By COVID-19 Are Restarting; Guidance for Patients
- WCG CLINICAL: Insights
- XTALKS: Clinical Development in the COVID-19 Era: Trial Continuity and Restarting Quickly, Safely and Successfully