Blood samples

Helping researchers test new COVID-19 treatments quickly

Accelerating research has become more important than ever in the face of a global pandemic. By creating a model that meets the need for speed, the Clinical and Translational Science Award (CTSA) hub at the University of Minnesota (UMN) can hasten the development of therapeutics—not just for one candidate, but for COVID-19 treatments being developed across UMN. 

A clinical research support model designed for speed

This is because at UMN, clinical research experts are united in one location: the Clinical Research Support Center (CRSC). This gives researchers a convenient, go-to place to tap into experts from more than 20 research support groups who work in a coordinated, collaborative way to quickly advance projects. For example, when studies are trying to get started, experts can help by mapping out next steps, pulling in the right people, and developing plans and protocols to make the leap from idea to implementation. 

The center is administered by the UMN Clinical and Translational Science Institute (CTSI), along with the Office of the Vice President for Research, University of Minnesota Physicians, and Fairview Health Services, a local hospital system and UMN CTSA clinical partner. Many experts come from these units, including CTSI’s experts in regulatory, recruitment, informatics, contracts, financials, clinical research, IRB preparation, biostatistics, and more.

Accelerating the clinical trial start-up process

Initiating a clinical trial is a complicated and time-consuming process that typically takes four to six months. But the CRSC can do this in a fraction of that time. 

For example, the UMN Masonic Cancer Center Clinical Trials Office (MCC CTO) and CTSI successfully translated a Phase 1 cell therapy trial for COVID-19 treatment from idea to FDA and IRB approval to Site Initiation Visit (SIV) in 45 days

“That start-up timeline is one for the record books”, says Jeff Miller, MD, Deputy Director, Masonic Cancer Center. “I wouldn’t have believed this was possible had I not witnessed the talent, dedication, and teamwork in those six weeks.” 

By working through the CRSC, researchers had a simple way to access experts from across UMN and the broader health center. Experts from CTSI helped with all aspects of initiating the study in collaboration with the MCC CTO, providing support for study planning and coordination, biostatistics, financials, IRB submissions, regulatory issues, and more. Through the CRSC, the team could also tap into experts from the UMN Sponsored Projects Administration (SPA), the IRB, and Fairview Health Services.

Teams are closely coordinated every step of the way, as part of the CRSC’s culture of collaboration. At the CRSC, study start-up activities happen in parallel, not sequentially, and account for all necessary aspects of clinical trials initiation. It’s this cohesive, collaborative approach that significantly shortened the interval from idea to implementation and enabled this study team to reduce the start-up time to 45 days compared to the typical timeline of up to six months.

Thanks to this coordinated approach, immediately available off-the-shelf induced pluripotential stem cell (iPSC) derived NK cells for treating cancer patients are now being tested as a potential COVID-19 treatment. If successful, this will become a new way to help these critically ill patients. 

A biobank to quickly design COVID-19 treatment candidates

A university-wide COVID-19 biobank also benefits from the CRSC’s collaborative, coordinated approach. By actively engaging CRSC experts from the beginning, the study team made the leap from concept to IRB-approved protocol in only 13 days. CTSI experts wrote the protocol, drafted lab instructions, wrote the informed consent form, handled the IRB submission, and helped create a data repository and data registry. 

Now the CTSI-supported biobank is up and running, collecting and housing specimens from patients infected with the novel coronavirus so it can be used by researchers across UMN. The biobank plays a critical role in quickly uncovering SARS-CoV-2 host-virus interaction and advancing COVID-19 research because investigators across UMN can use the specimens to develop new treatments, vaccines, and other therapies. 

“I became PI of this study the first week of May and on May 27 we enrolled our first patient,” says Luca Schifanella, MD, PhD, the study’s PI. “This would have never been possible without the help, effort, and dedication of this [CRSC] team.”

A centralized biobank accelerates the research process for individual studies. COVID-19 studies that wish to use the biobank do not have to write time-consuming specimen collection protocols or implement complex collection procedures. Instead, they simply request access to the biobank through a much shorter and faster IRB-approved process. This allows new prevention and treatment studies to get started much more quickly, lessens the burden for the research community, and removes pressure from the clinical team by centralizing sample collection and standardizing the process of consent.

A focus on collaboration and innovation

CRSC experts have been working together in a single location for nearly two years, creating a strong foundation to build on. Traditional silos had been dismantled, and the teams all have a strong culture of collaboration and innovation. 

This has enabled cross-disciplinary teams to pursue innovative methods to increase the speed and quality of clinical research. This collaborative, innovative approach has been even more valuable when COVID-19 hit. It was the CRSC’s fast, effective approach that enabled it to speed the development of new treatments and projects across the UMN. 

As of early June, the CRSC had provided rapid and comprehensive support on 49 COVID-19 projects. Exploring more treatments more quickly is critical to helping those who are infected and serves as a model for the broader UMN research portfolio.