An ongoing quantitative survey conducted by Continuum Clinical in partnership with the Association of Clinical Research Professionals (ACRP) shows 31% of clinical research study sites fear total closure as COVID-19-related stay-at-home orders and patient concerns over interacting with healthcare professionals continue to increase. Nearly 80% of sites indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.
Continuum Clinical, a global clinical trial enrollment company, and ACRP, a nonprofit organization with more than 13,000 clinical research members across 70+ countries, fielded the survey April 1-4. Results from the 297 responding US sites show clinical research study sites not actively working on COVID-19-related studies have been heavily impacted by the global healthcare crisis.
“These repercussions to the clinical research industry should raise alarm bells beyond just sponsors and CROs,” said Continuum Clinical president Neil Weisman. “When clinical research studies are put on hold, like at least a third of sites are expecting, the development of life-saving therapies is also put on hold; treatments that give patients hope are put on hold. The outcomes are far-reaching and potentially devastating to medical progress.”
Of the sites who reported patient dropouts, 80% said patients are unwilling to visit the site for study appointments, with 52% of sites indicating they believe patients fear interacting with any medical professionals who may be in contact with COVID-19 patients. Home nursing visits, recently offered by the FDA as an acceptable substitute for scheduled drug administration study visits, are also feared not practical by sites – only 19% believe patients would permit home visits by clinical trial staff.
The survey also shows investigator sites are facing serious staffing issues, with 38% reporting employees experiencing difficulties working from home and 33% reporting employees are not fully engaged due to COVID-19-related disruptions.
“We are very concerned about the ability of investigator sites to continue operations both during –and after—this crisis,” said ACRP Executive Director Jim Kremidas. “The health of our clinical trial site ecosystem is critical to providing data to the frontline healthcare workers battling COVID-19 and the myriad of other challenges they face.”
In an effort to continue monitoring the impact COVID-19 has on clinical research, including identifying emerging trends, Continuum Clinical and the ACRP will continue to field the quantitative study.
“As the impact of COVID-19 on sites, patients, and sponsors continues to grow, we have to begin to consider the best ways to mitigate the damage done to the clinical trial industry,” said Continuum Chief Commercial Officer Ken Shore. “Sites and site staff will need help when it’s time to begin a return to normalcy: sponsors will need to make up for lost time caused by delays, patients will need to be reengaged, and together, we will have to find a way to ensure this industry is in a position to rebound.”