Partner Kyle Faget has authored a Journal of Health Care Compliance article, “The Role of Telehealth in Decentralized Clinical Trials,” about how the COVID-19 virus has forced the health care industry to embrace technologies, including the decentralized clinical trial model, that had previously and somewhat pejoratively been characterized as disruptive.
By leveraging digital technologies, she writes, decentralized trials can recruit patients across geographies, which has the impact of making the trials widely available, a critical enrollment tool for clinical trials targeting rare disease populations. Decentralized clinical trials also offer trial participants the convenience of receiving treatment in their homes or with little to no travel and often include some form of remote patient monitoring that allows investigators to observe study subject status in real time and collect data from patients directly.
“With so many obvious upsides, it is hard to imagine why decentralized trials did not win favor until the onset of COVID-19,” she writes. “So, why has there been such resistance to adopting this clearly innovative model for conducting trials?”