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, we will 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 TWO: Micro Trends Help Narrow a Smart Support Strategy
Part One of our series focused on macro trends, which indicate site enrollment rates were at their steepest decrease when COVID-19 positivity rates were at their steepest increase. Given the impending Wave 3 rate increase, this is helpful data in terms of alerting us that we should be prepared to see site enrollment rates dip. But how?It’s worth revisiting the two key principles Continuum has identified 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
This second part of our series on navigating site enrollment in the time of COVID will focus on the second principle.
COVID-19 has not spread across the country evenly, and although every state has been affected, rates of change can vary drastically from one location to the next. We have adapted to this reality by integrating COVID-19 data directly into our ContinuVue® platform so that we can monitor critical case trajectories at a site-by-site level.
Local Adaptability: One Size Does Not Fit All
COVID-19 has not spread across the country evenly, and although every state has been affected, rates of change can vary drastically from one location to the next. Therefore, it is crucial to identify case trajectories at the site level and provide resources when and where they are needed. Even during flat periods, every trial will have some sites that are experiencing disruptions from increased case counts.
Continuum has adapted to this reality by integrating COVID-19 data directly into our ContinuVue® platform so that we can monitor critical case trajectories at a site-by-site level and identify trends that will impact enrollment. The most common visualization of COVID-19 data are heatmaps. However, these are limited to showing data in only one slice of time and cannot effectively highlight changes in trajectory. Therefore, we have advanced the use of heatlists that enable us to view our entire trial’s current and recent history in one visual. This enables us to spot and address local surges in real time, improving enrollment performance across the board.
Heatlists provide a timely look at what is happening (and what is reasonably likely to happen next) at an individual site level. We can, in turn, use this information to make adjustments to patient recruitment tactics, like modifying media spends by market or increasing site support where needed. Adjusting strategy locally, by over-supporting sites who remain open and staffed and who are likely to be in areas less impacted by the virus, and, conversely, reducing support for those likely to be more impacted (either by office closures or low staffing) is a smart way to protect your ROI without shutting down your study in an entire state.
We have already seen the positive impact these real-time, fact-based decisions have had on our ongoing studies in previous waves. Another wave is coming – are you prepared to identify and implement these mitigation strategies?
If you want to see what a heatlist looks like for your study sites, we’d love to generate one for you – free of charge. Let’s connect.
