Rutgers pioneers a virtual approach to clinical trials, revolutionizing how studies are performed and increasing participant access
As the COVID-19 pandemic challenged the traditional approach to clinical trials requiring participants to travel to study sites, Rutgers pioneered a virtual design that allowed these life-saving trials to continue by gathering data from participants at home.
At the start of the pandemic, Rutgers and the New Jersey Alliance for Clinical and Translational Science (NJACTS), based at the university, partnered with Vault Medical Services to assist in virtual recruiting and remote diagnostics. Participant consents, which were previously signed on paper, moved online to a HIPAA-compliant platform, while study data are being captured via home computers, smart phones or devices, and clinician visits.
The decentralized approach also expanded opportunities to reach lower-income and underrepresented participants who were previously unable to engage in clinical trials due to work schedules or transportation access, and has broadened the studies' geographic coverage.
"Decentralized, virtual clinical trials will be the future of clinical research. They will rapidly facilitate the development of new therapeutics and medical devices to promote the health of all Americans," said Reynold Panettieri Jr., vice chancellor for translational medicine and science and director of the Rutgers Institute for Translational Medicine. "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. This at-home clinical trial format has broadened the population who can participate, such as the elderly and younger adults who won't have to take off work."
Current examples of virtual clinical trials at Rutgers:
- A study examining if home air cleaners reduce the level of coronavirus in homes of COVID-19 positive adults. Details on the study and coordinator contact information were distributed to recently diagnosed adults in New Jersey. The target was 20 participants, but the virtual approach allowed the trial to expand to a target of 40 participants.
- A study that will test the preliminary efficacy of two doses of a combination of probiotics given to boost the immunity of unvaccinated people with prior confirmed SARS-CoV-2 infection. The virtual approach allowed the study team to recruit in five states (NJ, NY, GA, MN, TX) using Vault's SARS-CoV-2 testing database and social media. Rutgers is using Vault's network of clinicians to conduct at-home visits with participants.
- NJ HEROES (New Jersey Healthcare Essential Worker Outreach and Education Study - Testing Overlooked Occupations), which aims to better understand COVID-19 testing patterns among underserved and vulnerable populations; strengthen the data on disparities in infection rates, disease progression and outcomes; and develop strategies to reduce disparities in COVID-19 testing. Rutgers partnered with Vault to provide remote testing for all 1,963 participants.
See how we've united against COVID-19: rutgers.edu/united.
