As the coronavirus outbreak swept the globe this spring, it led to major disruptions in clinical trials. With stay-at-home orders in place and the health care system stretched to capacity, many clinical studies for drugs to treat a variety of conditions came to a halt or had to cease enrolling new patients.
But in the months since, clinical research has adapted to pandemic times. Researchers and regulators have been working to swiftly adopt technological advances and other changes that keep participants safe while maintaining the integrity of the study design. At Pfizer, many studies, including the current COVID-19 vaccine trial in the U.S., are being conducted utilizing virtual visits. These allow people to take part in research from home or without having to travel long distances to research sites. Industry leaders say that many of these innovative solutions to keep studies running during the pandemic may make sense in a post-pandemic world as well.
“Our hope is that use of technology in this way is the new normal,” says Rob Goodwin, a Vice President, Head of the Operations Center of Excellence for Global Product Development, based at Pfizer’s Groton, Conn. research site. “As we put these new processes in place, we’re making sure that they’re equal to or better to what we did before in conducting trials pre-pandemic.” Sharing some best practices, Pfizer recently contributed to the industry report “Beyond COVID-19: Modernizing Clinical Trial Conduct.”
Speeding up modernization
Prior to the pandemic, some of these technological upgrades, such as using electronic consent forms and digital data collection, were already being adopted. The coronavirus outbreak became a catalyst to implement these changes more quickly and on a larger scale. “We had already made some investment in new operations and systems, so we were able to move fast in response to the pandemic,” says Goodwin.
Among the biggest changes to be implemented since the novel coronavirus outbreak is the widespread adoption of remote site monitoring. Traditionally, clinical research associates (CRAs) visited research sites around the country to review patient data and other study information. But during the pandemic, most non-essential workers have not been allowed in hospitals and other clinical research settings. To adapt to the times, Pfizer development teams have quickly implemented data storage platforms, enabling CRAs to securely review patient data remotely. “Before this, site visits were almost always required,” says Goodwin. “Now, CRAs can do most of their job from a web browser. We’re reducing the number of people on site, and protecting our patients, our employees and the site staff.”
“Right from the patient, in real time”
For patients, many of these technological adaptations help them to participate in studies safely from home. In the current Pfizer COVID-19 vaccine trial, for example, much of the data collection happens remotely. Participants still need to visit the clinic site twice to receive their injections, but throughout the study they can report how they feel via an electronic diary. If a participant reports a potential reaction, such as a fever, in an electronic diary, site staff will schedule a telemedicine visit with the patient. Participants are provided with coronavirus testing kits to collect swab samples if they think they may have been exposed to the virus.
As we put these new processes in place, we’re making sure that they’re equal to or better to what we did before in conducting trials pre-pandemic.
Clinical studies are also continuing for potential treatments for diseases ranging from cancer to autoimmune conditions, with adaptations made so patients can participate from home. The trial medicine (either the potential therapy or placebo) can be sent directly to patients through the mail in discreet packaging to protect their privacy. And for those who feel comfortable, health care providers or nurses can visit their homes to take vitals, draw blood, or help administer the therapy.
For patients unable to travel long distances to study sites, some studies are now allowing blood to be drawn at a local lab or other health care setting in their community.
“All of this is designed to provide more flexibility for the patient,” says Goodwin. “In the future, these changes may help us to reach populations that may be uncomfortable with traveling to clinic sites and research institutions. It’s also increasing the quality of the information we collect, because we’re getting it right from the patient, in real time.”