“Strength through adversity,” while cliché, is still true of people and industries alike. Because when confronted with challenges, human inventiveness knows no limits. And nothing has been more exemplary than the past two years, with COVID-19 reshaping innovation and acting as a catalyst for the widespread adoption of new procedures and technologies in the healthcare world.
Clinical trials faced major disruption during the pandemic. When the outbreak began, some clinical trials shut down permanently, while others slowly resumed, creating a delay in the research pipeline that may hinder how quickly new treatments can come to market in the next few years. On top of that, COVID-19 fears have caused a significant decrease in enrollment.
However, if these unprecedented times have taught us anything, it’s that there’s flexibility in the clinical trial system. By changing some long-standing practices, countless trials that were cut back or paused were able to resume. The following major changes have been embraced nationwide and could be implemented long term.
Virtual and telehealth visits.
Participants often have to travel to specific research locations (which can be an hour or more away) at specific times (which can mean taking time off from work) to conduct assessments that, in many cases, could be performed remotely. So, rather than requiring participants to go to sites for every check-in or visit, many clinical trial leaders have turned to telehealth and virtual visits to keep operations steady. And as a result, telehealth and virtual visits have been accelerating as an option available to sponsors and participants. This proves that in order to advance clinical research and offer a patient-centric approach to studies, it’s critical to not only think about the patient but also think as the patient.
Participants in clinical trials often undergo an array of tests and data collection. From collecting samples to recording health records and inputting data – which can all be very time-consuming and expensive – a lot goes on behind the scenes of clinical research. When COVID-19 hit, trial investigators worked with sponsors to make testing easier for patients by reducing the number required, lengthening the time between tests, and arranging for samples to be collected at sites closer to participants’ homes.
Oversight from afar.
Prior to the COVID-19 crisis, sponsors spent a significant amount of time monitoring study sites to ensure operations were running smoothly. But now, part of this monitoring includes answering participants’ questions by phone or email, which significantly cuts down on travel time to and from the sites. Most of these new monitoring processes will continue to be done remotely via phone or video conference, and many investigators predict this will be the new way of overseeing future trials because it results in faster turnaround times.
As we continue to navigate the COVID-19 pandemic, the opportunity for innovation is right in front of us: to create real change in the way we design and conduct clinical trials. Especially as new variants of the virus arise, and with patient safety being the number-one priority, having a more hybrid approach to clinical trials with the added flexibility of telehealth will improve patient centricity and ultimately boost recruitment, engagement, and retention.
To discuss additional ways COVID-19 has impacted the future of clinical trials, get in touch.