Patient Enrollment at Sites in India, Endocrine Trials Hardest Hit by Pandemic
Year-over-year global clinical trial enrollment dropped nearly 65 percent per study site in March because of COVID-19, especially in trials focused on endocrine disorders and trials conducted in India.
Enrollment in studies for endocrine disorders was down 80.5 percent in March compared to March a year ago, a new report says. Following close behind were cardiovascular trials, which were down 69.7 percent, and central nervous system studies, down 68.5 percent. A Medidata analysis of 4,599 trials and 182,321 sites looked at declines in enrollment across most major therapeutic areas.
Dermatology studies experienced a substantial 64 percent reduction in year-over-year patient enrollment in March. Enrollment in infectious disease studies was down 46.8 percent, which is relatively lower than enrollment declines in other therapeutic areas. Additionally, oncology studies were down 48.4 percent. While respiratory studies had the lowest year-over-year change, patient enrollment in these trials was still down 33.7 percent compared to March 2019.
WCG’s Knowledge Base, which is tracking more than 1,000 sites in 29 countries, says only 14 percent of sites reported being open to enrollment last week. That was an 8 percent decrease just since the prior week.
More than 100 non-COVID-19 trials have been placed on official hold within the last month compared to 12 trials being put on hold the month prior to the start of the pandemic impact, according to WCG’s Knowledge Base.
The dramatic decrease in enrollment is also evident when looking country by country. In the U.S., patient enrollment in trials was down 66.7 percent last month compared to March of last year, according to the Medidata analysis. France and Spain have experienced similar reductions in patient enrollment of 68.2 percent and 68.1 percent, respectively, during the pandemic.
Nearly one-third (31 percent) of U.S. study sites fear total closure as COVID-19-related stay-at-home orders and patient concerns over interacting with healthcare professionals continue to increase, according to a separate survey conducted by Continuum Clinical in partnership with the Association of Clinical Research Professionals (ACRP). In that April survey of 297 U.S. sites, nearly 80 percent indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.
Of the U.S. sites that reported patient dropouts, 80 percent said patients are unwilling to visit the site for study appointments, with 52 percent 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 percent believe patients would permit home visits by clinical trial staff.
The Continuum-ACRP survey also shows investigator sites are facing serious staffing issues, with 38 percent reporting employees experiencing difficulties working from home and 33 percent reporting employees are not fully engaged due to COVID-19-related disruptions.
The global Medidata report shows that India has been the hardest-hit nation by COVID-19’s impact on trials. India experienced an 83.9 percent decline in patient enrollment in March year over year. The region with the second-greatest drop was the UK, which experienced an 80.1 percent decrease compared to March 2019. This unprecedented reduction in enrollment can be blamed on the suspension of most non-COVID-19 trials by the UK’s tax-funded National Institute for Health Research.
China, where the COVID-19 virus was first reported, had a 68 percent decrease in trial enrollment this March compared to a year ago. However, the Medidata report emphasized that patient enrollment in China during March was approximately 240 percent higher than the enrollment rate observed in February, suggesting the country is returning to business as normal after reports that COVID-19 cases there have declined sharply. Following close behind is Italy, which the Medidata analysis showed had a 52.3 percent year-on-year difference in patient enrollment in March.
The report also highlights the significant decrease in trial enrollment at Pfizer, Bristol Myers Squibb and Eli Lilly, in addition to smaller biotech companies like Moderna Therapeutics which is conducting a clinical trial for a COVID-19 vaccine.
To mitigate the impact of COVID-19 on clinical trials, Medidata recommends a shift to more virtualization and the use of leveraged historical clinical data to replace control group data. Additionally, sponsors are urged to shift their site mix to lower-impacted countries and regions. According to the report, these regions include Germany, which experienced only a 32.5 percent reduction in patient enrollment in March, and Japan, which experienced a 43.5 percent reduction.