By the Numbers: COVID-19 and the Future of Clinical Research Sites
The COVID-19 pandemic has once again exposed the increased vulnerability of small investigative sites when compared to their larger integrated research organization peers. Industry sources indicate that one-third of all U.S. study sites fear total closure. As of May 2020, according to WCG only 21 percent of clinical sites globally are now open to enrollment.
As the Association of Clinical Research Professionals (ACRP) notes, the numbers become even more concerning when you factor in the 31 percent of sites that are unable to forecast when they would re-open as the economic shutdown continues. Why is this last statistic so alarming? In 2019, a survey conducted by Society for Clinical Research Sites (SCRS) revealed that 59 percent of sites reported having less than three months of operating cash on hand.
The sobering reality that a large chunk of the most critical element in the clinical development supply chain – the research sites – may not “come-out-the-other-side” of the COVID-19 crisis has motivated the ACRP, SCRS and the Association of Clinical Research Organizations (ACRO) to call on sponsors to release site payment holdback funds as just one measure to reduce the damage.
The Power (and Limitations) of Pivoting
The efforts of industry organizations like ACRP, SCRS and ACRO shine a much needed spotlight on the on-going plight of the most vulnerable smaller research sites. Constructive recommendations from the research community can help to ease their burden. They also point to a recurrent theme for clinical sites since the outbreak of the COVID-19 pandemic – adaptability.
To date, the clinical research sites that were able to pivot in operations are the ones that have thrived. Examples include sites capable of offering COVID trials, quickly adapting SOPs to changing regulations, embracing telehealth and virtual trial opportunities, utilizing creative staffing models and restructuring in order to keep employees and participants safe. While these efforts, coupled with changes in budgets and contract agreements, can go a long way – especially when amplified through the collaboration of strong networks – more needs to be done to support the on-going health of small site operations.
This all begs the question: If small sites collapse under the weight of the COVID-19 pandemic, can they ever come back?
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