How the Pandemic Has Changed Clinical Trials

Newswise — Rutgers has pioneered a decentralized approach to clinical trials that is allowing researchers to accelerate the pace of finding cures, recruit lower-income and underrepresented populations that were previously unable to engage in clinical trials and broaden the studies’ geographic coverage, allowing for more diverse participants and, ultimately, better scientific outcomes.

“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. The decentralized clinical trials have allowed Rutgers to decrease implementation and recruitment times by 50 percent. “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 (NJACTS), 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. Participant consents, which were previously signed on paper, moved online to a HIPAA-compliant platform, while study data are being captured via home computers, smartphones or devices, and clinician visits.

“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 Panettieri. “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 lower-income and underrepresented participants who were previously unable to engage in clinical trials due to work schedules or transportation access, and has allowed us to broaden the studies’ geographic coverage.”

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.