The impact COVID-19 has had on clinical trial operations – and especially sites’ ability to enroll patients – continues to be enormous. There are no easy answers; avoiding significant pandemic-related disruptions to trial timelines requires both an agile approach to patient engagement and a close eye on critical data.
In this two-part series [click to jump to Part Two], we explore complementary strategies – analyzing macro, country-wide trends and homing in on micro, local data – that, together, can help fortify your patient recruitment strategy against COVID-19-related enrollment disruptions.
PART ONE: Macro Trends Help Forecast Site Disruptions
We know by now that COVID-19 has had dramatic impacts on clinical trial enrollment activities. But the impact is not universal, with site enrollment rates variously increasing or decreasing over the past 8 months.
Based on our analyses of the comprehensive data we collect through our ContinuVue® platform and close collaboration with research sites, Continuum has identified two key principles for successful patient recruitment during the pandemic:
1. Contrary to expectations, total case counts are less important than the trajectory of case counts: surges in new cases have an obvious negative impact on enrollment, but sustained case counts (even if high) do not appear to be as detrimental
2. Like other COVID-19 mitigation efforts, success requires a combination of standardized best practices and local adaptability
The first part of our series on navigating site enrollment in the time of COVID will focus on the first principle.
Rate of Change: Case Trajectory is the Biggest Disruptor for Sites
Spring and summer brought two separate “waves” of increased COVID-19 diagnoses. In between those two waves, daily new case counts remained high and could have presented an ongoing problem for active sites.
However, the impact of high case counts alone was not nearly as dramatic as the impact of increasing case counts. It was the rate of increase, not the total number of cases, that caused the sharp decline in site enrollment efforts.
We can clearly see this effect when we compare site performance with daily new cases:
Fig 1
In Figure 1, we see that the two large increases, or waves, in US case counts led immediately to significant drops in site enrollment performance: a 40% decrease during the first wave in late March, and similar 35% decrease during the second wave in August.
Importantly, site performance actually improved during the time between the waves, despite overall new case counts remaining high. After the first peak, enrollment rates eventually doubled even though new COVID-19 cases only went down by 33%.
The fundamental lesson from this experience is that increasing case counts leads to uncertainty for both patients and sites as local governments change course. When case counts are steady, even if high, patients and sites have time to adapt and find it easier to engage in research activities.
The fundamental lesson from this experience is that increasing case counts leads to uncertainty for both patients and sites as local governments change course. When case counts are steady, even if high, patients and sites have time to adapt and find it easier to engage in research activities.
As we collectively stare down a third wave of rapidly increasing COVID cases, history suggests we can expect a proportionate impact on sites’ ability to enroll patients. Planning for this disruption now by establishing strategies to protect your study from a decline in enrollment rates can help mitigate the risk.
Click here to go to part two of this series, where we explore a new tool we are using to identify which strategies will work best to mitigate the risk of a nation-wide crisis.
Do you have a plan in place to support sites through the forecasted third wave of COVID-19 cases? We can help. Let’s connect.
