COVID-19 is rapidly changing how industries around the world do business—especially drug development. From accelerated timelines to increased enrollment demands, the clinical research industry faces an uphill battle when it comes to developing safe and effective vaccines and treatments for COVID-19. Embracing change is the only way to meet the needs of today’s rapidly evolving drug development landscape.
From accelerated timelines to increased enrollment demands, the clinical research industry faces an uphill battle when it comes to developing safe and effective vaccines and treatments for COVID-19.
COVID-19 has created a demand for technology that the clinical research industry has never seen before, including standing up some of the largest studies the vaccine industry has seen in recent years.
Lynlee Burton, PRA Health Science’s Executive Director and Head of the Center for Vaccine Research, is no stranger to fast-paced environments. “Startup timelines and deadlines are nothing new to vaccine researchers. We embrace them,” she explains. “But with COVID-19, we’ve encountered challenges that have turned our industry upside down.”
Speed is the name of the game when it comes to vaccine trials. However, the demand for a COVID-19 vaccine is unlike anything we’ve seen in recent years. Fortunately, vaccine researchers are responding with innovation.
“We’ve seen some extraordinary new responses from our industry,” says Lynlee. “Partnerships between small and larger vaccine companies are quickly forming, regulatory agencies are prioritizing their clinical trial review, and governments and non-governmental agencies alike are providing an unprecedented level of financial support for COVID-19 vaccine development.”
These adaptations extend far beyond vaccine development. At the basic clinical trial level, the mindset of how to work on a trial is changing. CROs are adopting new processes to meet the unique demands of the COVID-19 environment. This includes beginning tasks on clinical trial set-up before a final protocol, which translates to beginning activities at-risk. For example, PRA is setting up databases before final protocol, selecting and contracting sites based on a synopsis which ultimately leads to First Subject In as quickly as possible. The industry is also seeing simpler protocol design driven by shortened timelines. This can be a benefit as it reduces the burden for site staff and the subjects.
“This is something I’ve been asking for—that we design our protocols so that we only collect the information that we need and get to that ‘go’ decision as quickly as possible,” Lynlee says.
In addition to simplifying protocols, CROs and sponsors are also combining and adjusting them to meet today’s unique needs. Safety review committees that convene over the weekends are helping drug developers get the answers they need to move on to their next dose by a Monday. Databases are being developed in weeks instead of months. Teams are restructuring to ensure individuals are focused on just one study rather than working on dedicating themselves to multiple studies at a time. Additionally, enhanced funding for at-risk product manufacturing ensures drug developers have the supplies they need, when they need them.
Of course, these rapid and dramatic industry shifts present challenges. Clinical development is notoriously slow-moving when it comes to embracing change. Today, moving slowly is not an option. COVID-19 has created a demand for technology that the clinical research industry has never seen before, including standing up some of the largest studies the vaccine industry has seen in recent years.
Before the pandemic, vaccine studies with 15,000 subjects were practically unheard of—today, COVID-19 studies are looking to rapidly enroll 30,000 subjects in two months or less. Not only does this increase competition for study subjects, it increases competition for the sites and staff needed to execute these trials. Additionally, many of these studies are being conducted at sites and in countries that haven’t performed vaccine studies in the past, or at least haven’t in many years or at this volume. Finding experienced staff to effectively run these trials is a significant undertaking.
COVID-19 also presents logistical hurdles for clinical studies. Possible stay-at-home orders may prevent subjects from coming in for visits or study monitors from getting onsite. This increases the challenge of study surveillance, especially on the large-scale basis needed for these enormous vaccine studies.
Fortunately, technology is helping drug developers face these challenges head-on. Video consults, e-consent, and Bluetooth devices help researchers communicate with and monitor subjects who are unable to come into the site for visits. They also ensure critical safety data is collected and transmitted directly to the site so that study staff can watch for and proactively address any issues such as injection site reactions or adverse events in real-time. Smartphones, devices that most subjects already have with them 24 hours a day, allow sites to remind subjects to track their symptoms and record their vitals with just a simple push notification, improving compliance and study participation.
So, what does the new normal look like for vaccine research? COVID-19 studies have inspired a lot of positive changes that should be continued far past the current moment. However, some of the processes and modes of operation spurred on by the COVID-19 pandemic are not sustainable.
“Super-fast speed enrollment, approvals, and protocol writing is amazing to see, but it’s not always the best choice,” Lynlee explains. “Many of these processes, including building databases, writing protocols, and implementing rapid startups, have heavy resource needs to meet these robust timelines.”
Is it possible to increase the speed and quality of trials while also saving money?
“I think that’s a real goal that we as an industry need to embrace,” Lynlee says. “It’s really important now and as these trials go on that we continue to learn and focus on the changes that are sustainable.”
One change to prioritize is a team dynamic that allows researchers to focus on one study at time. This eliminates the need for study staff to multitask and allows them to really dedicate themselves to that one clinical trial, ultimately providing superior quality work for the subjects and to the sponsor.
Protocol simplification is another sustainable change. “I think we’ve had an overall change in mindset about what kicks off a clinical trial,” Lynlee says. “We can begin designing case report forms, talking to sites, and doing submissions all at the same time that we’re writing a protocol. The final protocol shouldn’t be the ‘go button’ to start all of these other activities.”
Perhaps the most important change to carry on to future vaccine trials will be continuing to embrace technology. Technology puts subjects first, ensuring that a study fits into their lifestyle—not the other way around. Integrating remote visits and other home healthcare options allows researchers to see subjects without increasing their burden of participation. Not only will this help retain patients, it will likely encourage more volunteers to participate in future studies.
Today’s COVID-19 climate is both a challenging and enlightening time for the clinical development industry. As Lynlee states, “Now is the perfect time to embrace technology and feel confident that we can reduce the burden for both sites and subjects. We can access data in real-time, make decisions faster, and ultimately, get safer vaccines available to people quicker.”