Report sees ‘untold’ coronavirus impact on clinical research

Science 37, a provider of services enabling virtual/decentralized trials, suggests that global health is already witnessing an ‘immense’ impact of the pandemic.

Amidst that, the impact on clinical research, trial sponsors, research investigators and trial participants has gone ‘virtually untold’, states the company in a relevant whitepaper​.​ The document presents certain steps that pharmaceutical companies could take to mitigate risks to ongoing trials.

“We are seeing a significant and growing number of cases where clinical trial participants are refusing to visit hospitals or local clinics for fear that they could be exposed to COVID-19,” ​said Jonathan Cotliar, chief medical officer of Science 37.

“By all accounts, we expect this issue to continue to compound over time, which makes risk-mitigation strategies an imperative to protect the safety and well-being of participants and to enable business continuity,” ​Cotliar added.

According to the company, replacing visits at the clinic with telemedicine investigators and at-home nurse visits could be one of the most critical steps in overcoming the pandemic hurdles and avoiding disruption on clinical development.

The report suggests that the majority of clinical trial visits can be conducted remotely with the help of technology services and by utilizing a network of investigators trained to manage the technology as well as the participant relationships.

Moreover, nurses visiting patients at home could be deployed to collect blood and biospecimens, monitor vital signs, complete protocol-specified procedures and capture data, however taking all precautionary measures.

Nevertheless, the company suggests that remote visits, teleconferences and one-on-one home visits with a healthcare professional are preferable for patients over travelling to research sites.