Survey Cites Regulatory, Technical Obstacles to Remote Monitoring of Clinical Trials
A survey of sponsors and CROs found two-thirds of respondents cited regulatory and technical obstacles to implementing remote monitoring in clinical trials, but the COVID-19 pandemic has still accelerated adoption of the practice.
About 45 percent of respondents to a recent survey by Agatha, a life sciences software company, said they were using remote monitoring to a degree, while 32 percent had already deployed significant remote management processes. An additional 15 percent said they were not using remote monitoring processes but planned to do so within the next six to 12 months. About 7.5 percent had no plans to start remote monitoring.
Agatha also found that more than 41 percent of respondents cited technical barriers to implementing remote monitoring, while 22 percent said they were hesitant to adopt a new model without regulatory certainty, especially on issues such as sharing patient data.
About 17 percent of respondents to the survey cited behavioral factors, such as increased time and effort required by site staff. Just under 19 percent said economic concerns were at issue, including confusion around costs and who should ultimately pay.
“Many sites want to move to remote monitoring,” Ken Lownie, head of North American operations for Agatha, said during a webinar sponsored by Agatha and CenterWatch last week. “They’re willing to do the work, but it’s not clear at all to them that they have the right to do so because sponsors and CROs decide systems that are going to be used in studies.”
Lownie said the primary driver for remote monitoring before the coronavirus hit was cost. He cited a study published by the Journal of the American Medical Association in September 2018 that looked at cost estimates for clinical trials that supported 59 new drugs approved by the FDA in 2015-2016. The study found the median estimated cost of a clinical trial during that time frame was $19 million, with half of the 138 trials studied costing between $12 million and $33 million.
“It’s not how much the studies were, it’s what percent was travel,” Lownie said. He cited a separate study that used similar data from 2016 that showed on-site monitoring “tended to be 25 to 30 percent of the overall cost of clinical trials. The travel portion of traditional monitoring and quality inspections is really enormously high.”
Lownie added that while remote monitoring “was always emerging as a new alternative” in the clinical trials space, he conceded that the pandemic “accentuates” the pursuit of lower costs “because it’s showing people how much they can save. I think the changes that we’re seeing with increased remote monitoring are here to stay. I think it’s only going to accelerate.”