Nothing is certain in the wake of COVID-19. As we move into “recovery,” it’s become clear that the path forward is crooked and circles back into itself. Such uncertainty is crippling as sites and sponsors prepare to take trials off hold and launch new ones. But it does not need to be. If we learned one thing from the pandemic, it’s this: ours is a resilient industry.
Think about this: As of June 2020, COVID-19 was unheard of nine months ago; now we have roughly 2,000 active trials underway, 350 of which are industry-sponsored.
Sponsors launched an unprecedented number of trials in an incredibly short period of time. Most of the COVID-19 trials we’ve been monitoring have gone from final protocol to first-patient first-visit in four weeks.
The industry also became more agile. In an evaluation of about 40 industry-sponsored trials active as of March 30, about 21% of the products were immune mediators and about 25% were antivirals. In just two months, there was a dramatic shift to about 35% of the trials being immune mediators and 24% being antivirals. Sponsors and sites took real-time information and pivoted.
This speed and agility must be–and we believe, will be–built into development of trials moving forward. It doesn’t have to take three to six months to get a trial off the ground and get patients treated.
That especially matters now, as we’re seeing so many new trials and restarts on the horizon.
Backlog and Resurgence
Enrollment in new, non-COVID-19 trials have slowed significantly as trial holds have increased. Take April as an example. Roughly 130 studies were put on hold that month. The average number going into 2020: seven per month. Meanwhile, as trial starts have declined, the number waiting to start has increased significantly.
That is a considerable backlog. Sites and sponsors must brace for the collision of new trials with restarts for studies delayed as a result of that pause in enrollment.
WCG is tracking more than 1,400 sites in 29 countries to understand how much total trial enrollment is being affected during the pandemic. As of June 19, 30% of sites are now open to enrollment of new participants, up two percentage points from the previous week.
More trials are restarting, new ones are being launched, and more active COVID trials are starting. Fortunately, lessons we’ve learned from COVID-19 will help us, as we move into recovery, to address the challenges the pandemic creates.
As all this activity is happening, we’re seeing COVID-19 resurgences in several states. This presents an array of challenges to sites and sponsors, some of which will sound familiar; these were the same challenges we encountered at the initial outbreak. But now, we know more.
Assess safety: What measures do sites have to do to clean the facility? This involves a whole new layer of work on top of a site’s normal activities. How will they screen employees? Will they test for COVID-19? Do they have adequate PPE? And as we’re seeing, this is no longer merely a reactive response to a short-term problem. This is the new normal.
Assess readiness: Do an inventory of a trial–what is needed, what are the resources needed, what are the statuses of the study, of the site and of the patients themselves. Many sites remain understaffed, and others may be forced to reallocate staff as hotspots emerge. How will sites and sponsors plan for that? Don’t forget to check expiration dates for study drug, lab kits and other supplies.
Make contingency plans: Build in more flexibility to avoid putting studies on hold. Sites and sponsors may need to plot out many alternative paths to the same objective and be ready to shift quickly. Put in place a robust plan B and plan C–and communicate those changes to everyone affected. And be sure to have a plan in place to deal with missing data? Are there processes in place to document what happened and why?
Moving Into the Next New Normal
Sponsors and sites had to pivot quickly as the world changed, and they did. Before this year, virtual trials were rare, but sponsors and sites adjusted. Many sponsors had little experience with virtual trials and especially remote monitoring. Then suddenly, it became the only way to keep a trial going. They adapted.
Anecdotally, one of the things we’ve heard from clients is that planning efficiency has increased dramatically. People are now much more focused on arriving at a speedy resolution, and they are far more prepared in how they approach discussions.
All of this is to say that many of the “temporary” changes we made to address this particular crisis have turned out to be improvements, not stop-gap measures.
For instance, expect broader use of remote and virtual approaches, and a variety of technologies to enhance participant convenience. Continuous monitoring will also allow us to supplement data that’s coming from randomized controlled clinical trials with real-world data.
We’re starting to see interesting data come out of the adaptations made during the early weeks of the pandemic. For instance, many of the electronic solutions have been working better than anticipated, but some areas still need work, such as standardizing an approach to e-consenting and appropriate use of electronic regulatory notebooks.
Sponsors and sites previously dependent on paper records must now embrace digital solutions. Most sponsors have already moved in that direction, but some sites have lagged. That’s changing, but in some cases not fast enough.
Telemedicine is surging. The enabling technology, including wearables, real-time big-data analytics and visualization, e-consent, ePRO, eCOA, etc. has been in place. Now, as we move to virtual trials the key is to leverage them in ways that ensure data integrity and patient safety.
Patients are getting comfortable with virtual visits with their physicians. Some may not want to go back to face-to-face interactions for every visit in a clinical trial. That’s not the only ways your engagement with participants will change.
Renewed Focus on Patient-Centricity
The pandemic has led to greater focus on the patient as an individual. The concept that clinical trials place a burden on patients is nothing new, but the pandemic made it unavoidably obvious.
It’s incumbent on us to stay in regular contact with patients, not only to monitor them, but to reassure them. For instance, pandemic-specific standard operating procedures are essential, but putting them in place is not enough; we must communicate those steps to patients.
We need to keep them appraised of other aspects of the trial as well. We’ve heard from patients and patient advocates that patients too often have been left in the dark about the status of a study put on hold. Sponsors and sites don’t return calls or emails, frustrating patients–and possibly hurting retention.
From reassessing the patient burden to the need for ongoing communication, from leveraging real-world patient-provided data to educating patients and family members in drug self-administration, sites and sponsors thinking about the role of the patient in new ways. COVID-19 has forever changed how patients — as well as sites, sponsors, CROs, etc. — engage in clinical research. We believe those changes, after a rocky start, will be positive. But everything rests the ability to adapt. Because there isn’t just one new normal. There are a lot of them, and we must be ready.