Eli Lilly and Company and Care Access Research have forged a unique partnership to develop and manage a first-of-its kind decentralized, mobile trial to safeguard the health of patients in nursing homes. Lilly and Care Access will take the trial directly to patients. Lilly has worked with Care Access Research, a decentralized research organization (DRO) that operates as one connected team of physicians and nurses, for several years.
“Lilly has spent years figuring out ways to be more innovative with our clinical trials,” says Nicole Sheetz, clinical systems director at Lilly. “We are passionate about doing more for our patient community and the effort with Care Access Research is an example of that. We are working hard to try and move away from slow and cumbersome trials that are centered in large hospitals. We have implemented a relatively aggressive yet pragmatic seven-year strategy to implement decentralized trials. Our focus is to bring the trial to the patient and meeting them where they are, regardless of their background and location.”
“This is a prevention study,” says Ahmad Namvargolian, CEO and co-founder of Care Access Research. “We are going to long-term care facilities and offering this research study to any resident or staff member that is not COVID positive but is at high risk, trying to prevent them from getting the virus.”
Simulations Hone The Process
COVID is the worst pandemic the world has seen in years. While its impact has been extremely negative, it has resulted in improvements in the clinical trial process. When the decision was made to undertake a clinical trial for COVID-positive patients, Lilly knew it would have to reach a patient population that was vulnerable and resided in nursing homes. The work also had to be done quickly.
“The pandemic was not slowing down for anyone,” says Sheetz. “We got together with Care Access in early June and started sharing ideas. We began planning for the trial and conducting simulations. We had a multiyear partnership already in place with Care Access and that allowed us to create what we call Sites-On-Demand which allowed us to move at an accelerated speed. Through this partnership we were able to deploy this trial directly to a long-term care facility in late July, just six weeks after we started planning for it.”
The simulations were a way of testing the model to make sure it would work prior to running it with patients. Lilly, Care Access, and a couple of partners were able to put employees in the shoes of the clinical site staff, the investigational product preparation staff, and the patients. Individuals were able to walk through the trial as if it were being executed. According to Sheetz, this allowed everyone to make sure all the processes, the quality, and oversight was top notch before taking it into the field.
“At Care Access we have spent years building out the capability to bring research to places where it doesn't exist,” says Namvargolian. “We believe it’s important to take clinical research to patients where they are. Traditionally that has meant neighborhood clinics that are located where vulnerable populations are and where they may not have access to research. This study was an example of that. Our goal is to take clinical research to these communities that would otherwise be forgotten.”
A Need For Speed
The COVID clinical trial Lilly now has in place can be deployed and up and running at a facility within 24 to 48 hours of a known COVID case. In fact, that timeliness is necessary.
“The protocol for this study requires us to enroll patients within a seven-day window,” says Namvargolian. “That’s a tight timeline and every day lost is a day taken out of that enrollment timeline. Therefore, we have an urgency to do this as quickly as possible. Each one of these deployments is like building a new clinical research site. Normally it would take several months to do that. We have the resources available and ready to dispatch very quickly.”
Sheetz agrees that speed was key to this study. “We are operating like one big site, and that is a game-changer,” she says. “That allows us to properly manage the investigational product and any equipment that needs to travel from centralized parking garages to each of these long-term care facilities. There are two parallel things that must occur. The first is organizing the people. We need to orchestrate and pull together the clinical team, that includes the investigators, patient educators, clinical research coordinators, and research nurses, and get them to the nursing home. Second, we pull together and mobilize the equipment, the investigational product, and medical supplies transport team. We are often able to mobilize all of this in under 48 hours, depending on where the facility is located and the location of the staff and the trucks.”
The Right Technology
Sheetz notes an innovative cloud-based solution is enabling this trial and other trials taking a decentralized approach. The solution is called StudyTeam by Reify Health. The software was used to connect potential trial participants who are distributed across long-term care facilities. Individuals can join the wait list for the trial. A study team would manage recruitment on the ground and take potential participants through the pre-screening and enrollment process.
StudyTeam allows all patient information to be stored in one place. The software also allows study teams to understand what volume of resources might be required at a particular facility.
One facility might have 20 or 80 persons on the wait list,” says Sheetz. “We need to know how many people and what equipment will be required at each facility in those first 48 hours. The software also allows personnel back at Lilly to be able to look at enrollment data and recruitment data to troubleshoot potential issues and modify the approach used at a particular facility. Our approach could vary based on the facility or region of the country.”
Digitizing paper documents is also important. On-site staff might still be using paper, but many investigators work remotely and still need to access data immediately. Therefore, any paper documents generated by site staff must be digitized immediately. “That has been one of our core technology needs,” says Namvargolian. “We can now scan and upload the documents quickly.”
Now And In The Future
The question Sheetz gets asked most often is whether the trial changes being made today will continue to impact trials in the future. She is asked that question by patients, sites, and even folks within her company. Everyone wants to know if the innovation happening in COVID trials can be rolled out into trials in other therapeutic areas as well.
“I say hands down, without a doubt, this is definitely not just for COVID trials,” she says. “This is about virtualization and decentralization, but we do not want to take the human element out of trials. We do not want to throw technology at people and think that will make clinical trials better. At the same time, these changes are here to stay, and we need to use technology to our advantage. It has exploded over the past three to five years and continues to weave its way into all parts of our lives. Technology is here to stay, and we need to make it as accessible and easy to use as possible, while keeping quality at the forefront of all our clinical trials. We know we can do this and know we can do it in any community across America. We used to have hope that we could do it. With this trial, we now have proof that we can do it.”
“Taking trials to the patient is doable,” says Namvargolian. “It doesn't have to be a pipe dream anymore. We can finally stop talking about it and start doing it. COVID has helped us learn that we are not contained by the way we used to work. I would encourage everybody trying this to be as flexible as possible. One of the most important things I learned is if you are going to mobilize people into a decentralized world, communication is key. Sponsors cannot do this alone and neither can sites. This will require close partnerships with transparency and a shared vision for where we want to go. That is what made our trial so successful and rewarding.”