Rapid response team grows NIH study network during pandemic while keeping participants safe

In the push to find treatments for the novel coronavirus, a Frederick National Laboratory team helped enroll thousands of participants in clinical trials and brought on board community hospitals as new study sites to join the research effort amid the pandemic.

The partnership with community-based hospitals as clinical trial sites was highlighted in a recent commentary in Vaccine as an overlooked resource that should be part of future pandemic preparedness efforts. 

FNL’s Clinical Monitoring Research Program Directorate (CMRPD) employees worked with National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research to coordinate participation in the trials via video chat from their home offices, as the pandemic limited any in-person interactions or coordination on the ground.

But the CMRPD rapid response team has worked like this before. They have supported NIAID in conducting clinical trials for Zika, Ebola and other infectious diseases amid outbreaks in resource-limited countries, coordinating logistics from offices in Frederick

Testing investigational COVID-19 therapeutics quickly to save lives

NIAID turned to the team early in the pandemic to help launch the first clinical trial in the United States to evaluate investigational products for COVID-19. CMRPD connected with research coordinators at hospitals and clinics in established clinical trial networks and quickly set up an Adaptive COVID-19 Treatment Trial. 

Early findings showed the study drug remdesivir helped hospitalized patients recover faster than those who received placebo, so the team coordinated follow-on studies. At the same time, the ACTIV3 adaptive clinical trial and hundreds of additional COVID-related vaccine and treatment trials were being launched, all needing participants to enroll in these studies

However, between taking care of sick patients and running existing trials, many hospitals and clinics did not have the bandwidth to take on more. The clinical trial networks needed to adapt.

Scouting for sites

Image
USA map showing level of community transmission of all counties
COVID-19 Community Transmission Map October 25, 2021
US Centers for Disease Control.

Viewing a US map that depicted areas with high infection rates, the CMRPD team in collaboration with NIAID/DCR pinpointed regional hospitals in those communities and invited them to become study sites. 

CMRPD assisted NIAID/DCR in cold-calling hospitals and sending out surveys to determine if these hospitals would be interested in becoming a site for the trial,” said CK Osborne, a clinical project manager with CMRPD. “If they were interested but didn’t have certain capabilities or resources, we worked with them to determine what support could be provided.”

For example, freezers were purchased for hospitals that needed them and pharmacy training was provided on preparing the investigational product for administration. The team enlisted staffing agencies to hire experienced clinical research professionals to support the studies. Some of the temporary staff moved several states over to augment the resources need at the new sites. 

It turns out many community hospitals that don’t typically conduct clinical research had the infrastructure in place to do so, and they quickly came up to speed. “We partnered with NIAID to help the hospitals come on board, to conduct the complex research that we needed,” said operations manager Calvin Proffitt. 

CMRPD in collaboration with NIAID/DCR developed relationships and brought 17 new study sites on board, adding capacity to the clinical trial and giving participants in these community hospitals access to the investigational products.

A NIAID/CMRPD team helped the new sites understand the protocol and advised them as they implemented the study. The hospitals were excited to be part of the trial and were particularly thrilled when NIAID Director Dr. Anthony Fauci joined a team meeting on Zoom. 

The NIAID commentary in Vaccine was co-authored by CMRPD’s Shelly Simpson and others. It called the community hospital model a “force multiplier” and a “step toward creating a government-responsive clinical research surge capacity for future public health emergencies.”

Staying safe for follow up

A critical component of the clinical trial was post-discharge follow up visits. But returning to the hospital or clinic was not always an option for participants recovering from COVID-19. The CMRPD team engaged mobile phlebotomy companies with clinical research experience to safely complete the blood draws for participants in 11 states and return samples to the 22 sites.

“This was convenient for the participants and kept them protected, while also ensuring data quality,” Proffitt said. “It was critical to finishing the study and ensuring the required follow up occurred.”

Following COVID-19 long term

A year and a half into the pandemic, there are nearly 1,300 COVID-19-related trials underway in the United States. The studies are not only exploring investigational treatments but looking at the long-term effects of the disease. CMRPD is coordinating multiple COVID-19 studies.