COVID-19 has significantly impacted the way we live, work, and play. It has also had a significant impact on clinical care and real-world research. When the pandemic began, routine clinical care was largely put on hold and then shifted to virtual visits when feasible. The same can be said of clinical research for medical products. While some pharma companies opted to put their studies on hold and others kept studies open, the pandemic’s impact has been notable.
According to Global Data,1 69.9% of clinical trials were interrupted because of enrollment suspension. Results from a survey of over 5,000 studies and 198,000 study sites globally showed a decline of 59% in new patients entering study sites as of April 2020 compared to 2019 levels, with a decrease in that decline to 20% in August 2020. This same study showed the administration of study drugs has been interrupted due to the inability of patients to access sites and the pandemic’s effect on study drug supplies. These interruptions stem from concern for patient safety, lack of staff, and site access for medication administration as some medications must be given in a healthcare facility. Before COVID-19, perceived or actual regulatory or ethics committee hurdles and lack of willingness to try something novel kept the virtual clinical study model from being broadly implemented. However, the desire to continue bringing safe and effective treatments to patients, even during a global pandemic, has led to accelerated adoption of virtual study approaches; 67% of the Global Data respondents noted that COVID-19 is the reason for use of a decentralized model for the first time.