The option to take part in clinical trials through remote monitoring and virtual visits could help with recruitment, especially for those with multiple comorbid health conditions who find it difficult to travel, say researchers. Some aspects of pandemic-related trial conduct can and should remain moving forward, experts say, but caution is still warranted.
Conducting study visits remotely should only be done with careful consideration for clinical trials to provide the highest quality evidence, warn experts from Northwestern University and the University of Pittsburgh in the US, in a Viewpoint in JAMA.
With hundreds of trials still suspended due to the pandemic and others facing ongoing problems with enrolment, remote options for data collection have increased, they write. A survey of 245 clinical trial investigators in 2020 showed that the proportion of remote interactions – including posting devices such as pulse oximeters or delivery of medicines, as well as phone or web-based visits – increased from 9% to 57%.
The researchers give an example of one trial in which a randomised, double-blind, clinical trial of fluvoxamine in patients newly diagnosed with COVID-19 was done entirely remotely.
Eligibility screening was done by email and telephone and COVID diagnosis confirmed using electronic health records. Informed consent, baseline and follow-up self-assessments with a pulse oximeter, blood pressure monitor, and thermometer, were all done remotely with the drug also delivered to the patients’ door. Outcome data was also collected twice daily via email surveys or phone.
Such an approach could remain post-pandemic as increased availability of portable devices makes remote monitoring possible, they said.
But they added: “Some evidence justifies caution before abandoning or greatly reducing in-person visits for evaluation of clinical trial participants.”