Rutgers University has pioneered a decentralized approach to clinical trials that is allowing researchers to achieve better scientific outcomes as they accelerate the pace of finding cures, recruit lower-income and underrepresented populations that were previously unable to engage in clinical trials, and broaden the geographic coverage of studies.
“This approach that speeds the process of trials and allows more people greater access to participate in studies will in turn improve the depth of the research findings and will allow us to accelerate translating those findings into treatments,” said Reynold Panettieri Jr., vice chancellor for translational medicine and science and director of the Rutgers Institute for Translational Medicine. “The COVID-19 pandemic challenged the traditional approach to clinical trials, which required participants to travel to brick-and-mortar study sites. A crisis requires a nimble approach. Virtual clinical trials like the ones we have launched are fundamentally changing the way the industry conducts clinical trials.”
Clinical trials typically take six months to implement and up to 12 months to fully recruit participants, according to Panettieri. Decentralized clinical trials have allowed Rutgers to decrease implementation and recruitment times by 50%. “Further, we now reach participants who were challenging to recruitment, have decreased the cost of studies with the elimination of bricks-and-mortar facilities and have enhanced retention of study participants since they do not need to travel and can complete the studies in their home,” he said.
At the start of the pandemic, Rutgers and the New Jersey Alliance for Clinical and Translational Science, based at the university, partnered with Vault Medical Services to assist in virtual recruiting and remote diagnostics, which allowed people to participate at home through remote data collection and telemedicine consultations.
“Decentralized, virtual clinical trials will be the future of clinical research,” Panettieri said. “They will rapidly facilitate the development of new therapeutics and medical devices to promote the health of all Americans. As our logistics went virtual, we took an Amazon-like approach to clinical trials, obtaining specimens through FedEx and collecting data from people without requiring them to leave their homes.”
Participant consents, which were previously signed on paper, moved online to a platform that is compliant with the Health Insurance Portability and Accountability Act, while study data are being captured via home computers, smartphones or devices, and clinician visits.
Edited by Gary Cramer