Benchmark Data: How COVID-19 Impacts Clinical Research Site Performance

Trend data for clinical research sites during the COVID-19 pandemic.

COVID-19

Introduction

COVID-19 has brought unprecedented change to the way clinical research sites operate. Over the last month, these businesses have had to react quickly to health and safety risks, endure immense business pressures and implement operational processes to allow for new ways of working under pandemic constraints.

It can be hard to get a clear picture of how the site market is evolving in real time. There’s a plethora of headlines and communication from many organizations, but reliable data that shows how site and patient behaviors are shifting week over week are few and far between.

Like you, we’re looking for some concrete benchmarks. We looked at aggregated data from our customer base of thousands of sites to understand how key site performance metrics are shifting as our industry adapts to the COVID-19 pandemic.

We will continue to review the data and publish updates on a regular basis throughout this crisis and beyond. While it’s too early to make definitive predictions about how the research site community are evolving through the pandemic, we trust this initial analysis will serve as a valuable tool for you to benchmark your research business and inspire new ideas that help your site perdure.

About the data:

  • These insights are based on aggregated, anonymous system activity from thousands of CC CTMS (Clinical Conductor) users.
  • These metrics include data trend for key site operational metrics, focusing on changes occurring in March 2020 and afterwards.
  • Along with the weekly data, a benchmark data reference has been included in the graphs

Next update: May 6th – Read it here

Key Findings

Research sites are experiencing significant operational and business difficulties on several fronts as demonstrated by the changes in visit management metrics. Visit cancellations and difficulty scheduling new visits is impacting overall visit completions and subsequently sites’ expected revenue.

Research sites also had to adapt to an influx of protocol changes in early March as sites, sponsors and CROs began reacting to stay-at-home orders and patient safety risks became a reality.

Recruitment took a back seat for sites, indicated by declining amounts of outbound recruitment efforts, along with decreased conversions of recruitment prospects into study participants. Inbound prospect interest in site-advertised studies decreased in March, but to a lesser degree, meaning some folks are continuing to consider participating in clinical research.

Lastly, sites are working hard to stay active, as indicated by continued participant stipend reimbursements. There was also a spike in new studies added by sites in late March and early April and will be an area of interest in the forthcoming analysis updates .

Please note that you can sign up to be notified automatically of new insights as they become available by clicking the link below.

Protocol Changes

Protocol Changes

Sites recorded a spike in protocol changes about 40% higher than the baseline during the first two weeks of March. As research sites realized the impacts the COVID-19 would have due to stay-at-home orders and other mandated business closures, they reacted quickly. What’s more, sponsors and CROs reacted at the same time, as there was not any early reactions to the virus (which would have been noted in a spike in February.) Following this spike, protocol changes dropped well below the baseline, likely from the initial changes having more long-term impacts across more of a sites’ active study portfolios.

Visits Completed

Visits Completed

Since the week of March 15th, completed visits have dropped by 27%, clearly showing that the COVID-19 pandemic has made it difficult for sites to complete scheduled visits. What’s more, top-down protocol changes and sites’ proactive measures to reschedule March/April visits (mentioned below) likely contributed to fewer completed visits each week after the pandemic became a reality.

Visits Scheduled

Visits Scheduled

Visits scheduled declined since early March, and the first week of April recorded scheduled visits 45% below the baseline. This trend aligns with other leading indicators for scheduled visits, such as total study prospects and new participant enrollments (both highlighted below.) We will continue to track this trend and see how it evolves as COVID-19 continues to evolve, and if it mirrors the performance other related metrics.

Visits Rescheduled

Visits Rescheduled

After the first week of March, when the COVID-19 pandemic became mainstream in the US, research sites doubled the number of visits being rescheduled per week for three weeks in March. For some sites, this could result from sponsor/CRO directive. For others, site managers could be requesting all visits to be rescheduled to the maximum length the visit window would allow. The latter strategy buys time for sites, but additional rescheduling could result. In the most recent weeks, rescheduled visits have dropped slightly below the baseline.

Visits Cancelled

Visits Cancelled

In accordance with protocol changes and pauses for enrolling studies, cancelled visits rose sharply at the start of the pandemic, peaking the week of March 15th at 96% above the baseline level. From there, we have seen a decrease in overall cancellations.

We will monitor this metric closely, as rescheduled visits could potentially become cancelled visits if stay-at-home and business closure orders are extended throughout the US.

Patient Communication

Patient Communication

After the first two weeks of the COVID-19 pandemic, patient communication dropped by 50%. After sites initially connected with patients to announce relevant visit delays or cancellations, the data points to an emphasis on other site activities than patient communication.

Study Enrollment

Study Enrollment

Study enrollments decreased to 40% below the baseline starting in mid-March following a similar decrease in recruitment activities for research sites during the COVID-19 pandemic. So far, the data has not flattened, but we will closely monitor how enrollment numbers evolve for sites in the coming weeks as the pandemic progresses.

Recruitment: Prospect Conversion

Recruitment Prospect Patients

After the reality of the COVID-19 pandemic was appreciated by clinical research sites mid-March, the conversion of recruitment prospects to study patients decreased close to 80% the week of March 29th. Even in February, prior to the pandemic becoming an everyday reality for sites, there was a downward trend in prospect conversions. This could be attributed by initial prospect hesitation to commit to studies due to general uncertainty, and sites themselves could have potentially further extended this trend by deprioritizing recruitment as enrolling studies became paused.

Recruitment: Prospect Outreach

Recruitment Outbound

Further elaborating on the above metric, sites cut their total outbound recruitment efforts (calls, texts, etc.) to prospects as much as 80%, as seen the week of March 29th. If enrollment dates are deferred or if enrolling studies pause entirely, sites are wise not to try and convert prospects for studies when they don’t have certainty behind important visit/timeline dates.

At the same time, engagement for prospects remains important for future conversions. Sites could transition recruitment efforts into educational efforts to maintain contact with prospects and ensure ease of conversion once the COVID-19 pandemic passes and study recruitment resumes.

Recruitment: Inbound Patient Interest

Recruitment Inbound

Building on the importance of engagement, inbound prospect interest in studies decreased about 30% compared to sites’ outbound efforts. Even as enrollment remains difficult during the pandemic, research sites are still seeing patients come to them expressing interest in participating in studies.

This means that sites still have the potential to interact with many interested prospects. Using their interest as a way to build a relationship, educate and maintain contact could yield sites dividends in the future in new study patients.

Stipends Approved

Stipends Approved

While many key site operations metrics are dipping 40-60% during the first month of the COVID-19 pandemic, participant reimbursements (stipends) only decreased 20% in March. This could be an indicator of site creativity, where sites are finding ways to continue completing visits (or portions of visits) during the COVID pandemic. Tools to enable remote visits, changes to visit locations and other factors could be a component to this, and it is a key metric to track as the pandemic evolves.

Adding New Studies

Adding New Studies

Conversely to other metrics, sites’ new studies have not developed any trend up or down due to the COVID-19 pandemic. What’s more, there was a spike in late March for new studies above the baseline. In the most recent weeks, we have seen a slight trend upward in new studies. We’re curious if this will continue. If you are too, sign up here to stay updated using the link below.

Staff Activity and Staff Reductions

Staff Activity Vs Reductions

COVID-19 has impacted site activity and site staffing at all levels. In terms of general activity (unique clinical trial systems logins), we have seen a 22% decrease in overall activity since mid-March, and that trend is still on a slight decline.

Alongside this metric, it’s important to look at staff site staff reductions. The research site industry, similarly to other industries, seems to be subject to layoffs and furloughs. For the week of March 15th, we recorded a 350% increase in the percentage of staff reductions, an unprecedented spike. The spike can be attributed to tough decisions site managers are making while studies pause and incoming payments slows in order to sustain business continuity for the long term. However, since that week, staff reductions have returned to the baseline level.

What this Means for Sites

While this is early data, there are some apparent conclusions for sites:

Engagement remains essential

Even as enrollment decreases, sites have an unprecedented opportunity to remain connected to patients and potential study participants. Establishing your site as a resource through the pandemic and a valuable community foothold, you build valuable relationships that last long past the pandemic and build long-term relationships with people, creating engaged patients for the future. Moreover, engagement can be done remotely with email, two-way text and via phone!

Get creative and find ways to conduct research

Sponsors, CROs, IRBs and other leaders are understanding that sites need to get creative for some studies to continue operating. Sites need to collaborate, innovate and learn how to run research under this “new normal.” Data shows that, even in a pandemic, sites can add new studies and continue completing visits and issuing participant reimbursements. Leverage new software, find how existing tools can empower remote work and attend the plethora of free webinars put on by associations designed to help sites get through COVID-19.

We hope these benchmarks provide useful context as you monitor your site’s health in the coming months. We’ll release refreshed insights every two weeks. You can sign up to be notified of new insights as they’re available below. Don’t forget to share with your colleagues in the industry!

Read the May 6th update here.