The Innovations of Clinical Trials after the Pandemic

Like the entirety of the world, the COVID-19 pandemic exposed many issues in the medical industry. One area in particular: the clinical trials space developed many challenges as a result to the height and continuous battle of the pandemic.

Like the entirety of the world, the COVID-19 pandemic exposed many issues in the medical industry. One area in particular: the clinical trials space developed many challenges as a result to the height and continuous battle of the pandemic.

Two prime examples of challenges in this space included access to trial facilities and increased reliability on Telehealth.

However, through innovation, the medical industry and clinical trial space has improved since the height of the pandemic.

Clinical Trial Challenges

Inside the troubled access to clinical trial facilities, sites were forced to deal with the challenges of moving their non-clinical staff off-site, shutting down all on-site monitoring and deciding whether to continue enrollment during a very confusing and scary time, according to Catherine Gregor, MBA, CCRP, CCRC, chief clinical trial officer at Florence.

These access issues lead to many centers deciding to hold enrollment, which meant patients didn't have access to trial opportunities and study timelines were delayed.

"In my direct experience, clinical trials are an important part of cancer therapy," Gregor said. "When we did not know if we could continue to offer those opportunities to our patients, physicians and study teams were forced to make some uncomfortable decisions. However, as we learned more about how to manage the virus, we were able to open trial activities again."

Gregor added all therapeutic areas outside of cancer experienced significant drops in patient volume and closed enrollment for long periods of time. As of January 2021 there were more than 2,000 clinical trials that had been stopped explicitly due to COVID-19 restrictions.

Many research sites had to pivot their available research staff towards supporting COVID studies, as it was an all-hands-on-deck approach to moving those projects forward, she said.

Cancer trials remained open and enrolling during COVID, but there was a drop in screening and prevention visits, meaning that there are now later-stage cancers in clinics. This will inevitably cause centers to reevaluate their trial portfolios to better reflect the needs of their patient population, she said.

Clinical trial officers faced additional challenges such as how to keep patients safe while on study. However, these challenges created more discoveries.

The safety issue opened up further telehealth options for nurse and doctor visits, as well as collaborations between local point-of-care facilities like Walgreens and CVS to pull vital signs and labs. The partnerships created protected time slots for patients to go in and have procedures done and maintain social distancing. We also learned that we could ship investigational drugs across state lines so that patients did not have to travel to get their medication.

Sites and sponsors were also forced to leverage technology to maintain operations in the face of travel restrictions and an expanded remote workforce.

Gregor added clinical trial officers also learned how to administratively manage trial activities like data and regulatory filings via electronic systems across a remote workforce. For a number of larger Academic Medical Centers and health systems, this was a new experience, she said.

In addition, the healthcare industry pushed through traditional barriers to quickly activate and enroll trials. For example, the FDA provided guidance that allowed sponsors and sites to be more creative in how they cared for patients on studies, giving them license to waive off unnecessary data points such as prolonged pharmacokinetics, and instead focus on primary endpoints and patient safety.

"The question that remains to be answered now is how all of those minor deviations will add up to potentially impact regulatory approval decisions in the future," she said.

Outside of regulatory approval decisions, Gregor shared what she believes will be the future of the clinical trial space in the next few years.

"The landscape will continue to evolve as sites and sponsors explore technology that links them to each other," she said. "Data flow from participants to the site to the sponsor will become more seamless as sites and sponsors begin to look for software with open APIs (software that can integrate, even if it’s from different vendors.)"

With integrated technology, sponsors and sites will be able to eliminate redundant data entry and help speed study timelines, she said. Additionally, better connectivity between sites and patients creates opportunities for wider inclusion of patient populations and increased retention and engagement with study activities.

Flexible workflows will also continue to grow in importance.

"Sites should have the ability to establish and maintain their own study workflows instead of being forced into pre-defined ones," Gregor said. "This flexibility allows sites to spend less time managing study data and more time managing patient care, which is where the true value is for all of us."

Lastly, sites and sponsors will keep exploring ways to make trials more patient-centric: bringing the trial to the patient rather than the other way around. Reducing travel to and from major academic centers decreases time and financial burdens to participation, and moving studies into local communities opens opportunities for inclusion that would not otherwise exist.

Gregor added this opportunity will likely mean a higher emphasis on hybrid trials, or trials that combine decentralized methods with in-person visits. She said site visits can be strategically blended with telehealth updates, submitting data from home, and visits to local pharmacies to serve all patients, especially low-income patients or patients who rely on public transit. In particular, these patients often can’t take time off work or travel long distances to make study visits. She encouraged to blend site visits with appointments in their own communities.