As the COVID-19 pandemic continues, researchers have been forced to put important projects on hold—and it’s unclear when things will return to normal.
A new analysis in Circulation: Heart Failure explored this issue, examining on how the pandemic has affected a large-scale clinical trial focused on cardiovascular outcomes.
The study’s authors surveyed the clinical research coordinators of heart failure programs participating in the CONNECT-HF clinical trial. CONNECT-HF is an ongoing cluster-randomized trial originally designed to track the health of patients after being hospitalized for heart failure.
Surveys were sent out in May 2020, and a total of 87 clinical research coordinators responded. Overall, just 11.5% of the programs designated research related to CONNECT-HF as essential. In addition, 32% of the heart failure programs had resumed clinical research as of May 2020, with another 27% considering a return within the next two to three months. Forty-one percent of programs, meanwhile, indicated that they had no plans to resume clinical research as of May 2020.
The authors also noted that the participating programs—representing a mix of academic health systems, large tertiary hospitals, community hospitals and public health centers—were wildly inconsistent when it came to how they made key decisions.
“There was considerable variation in where sites obtained guidance when determining how to resume clinical research activities: 5.2% followed federal guidance, 28% used state guidelines, and 7.2% used city/county guidance,” wrote lead author Marc D. Samsky, MD, Duke University School of Medicine, and colleagues. “Over half of reporting sites used a source not listed or were not aware of specific guidance.”
Samsky et al. also found that 42% of responding coordinators said they felt “at least some degree of fear” about returning to work. Another 32% “expressed little to no fear,” and 26% were neutral.
“During the COVID-19 pandemic, regulatory agencies have advocated for operating clinical research programs with flexibility; ensuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risk to trial integrity,” the authors wrote. “Unfortunately, these recommendations do not provide tangible ways to ensure continuation of research activity. By reducing in-person visits to keep participants and staff safe, it is unclear how slowed enrollment, delayed follow-up visits, and not having ways for reliable safety assessment will affect future outcomes actively enrolling clinical trials.”
The authors wrote that allowing researchers to work from home, “when feasible,” could potentially make a big impact on current clinical trials and those that will be carried out in the future.
The full study is available here.