We recently sat down with BBK’s Director of Accounts David Fleishman to discuss his experience working with clinical trial sponsors during the COVID-19 outbreak. It’s clear from our conversation that many clinical trial sponsors have had to quickly pivot in response to COVID-19 and are now facing the challenge of adapting to a new normal.
Based on your experience, what impact has COVID-19 had on your clients? Have many of them suspended their studies or responded with efforts to maintain momentum and minimize disruption?
We’ve seen clinical trial sponsors all over the map with their response to COVID-19. Some have halted studies because sites couldn’t receive patients. Some have been able to change in-clinic to home visits and continue recruitment and participation. Some, whose studies haven’t started yet, have put everything on hold until more is known about COVID-19. And for those who have suspended or delayed their studies, they’ve chosen to use this time to prepare and develop recruitment and engagement materials so they are ready to hit the ground running once studies re-start and sites re-open.
I believe the smart approach is to continue to push forward – even if it’s just planning and preparation. Study start-up can take a long time, so utilizing this time productively in order to be ready once the hold is off can be really important and can potentially help accelerate getting to market sooner. Many companies have started to recognize that this could be the new normal and have not halted their efforts, choosing to work through it. In my opinion they’ll be ahead of the game.
What has been the biggest concern you have seen in response to COVID-19?
As we all face this new challenge, many sponsors have been looking to us for assistance with not only recruitment but with study operations. We have assisted many clients in helping them figure out how to navigate operations with initiatives such as our medication delivery service or traveling nurses. From an enrollment perspective, they are looking to understand how they can continue enrollment despite the challenges of COVID-19. Specifically, they want to understand “How do we make patients feel comfortable enough to continue to go to study visits?” and “How do we need to change the protocol to support their continued participation?” We’ve been able to successfully support them and alleviate some of their concerns, which has been personally rewarding for me.
Can you talk a little about virtual engagement? Have your clients embraced virtual solutions to help get through the challenges of COVID-19?
Yes, a few of them have. Virtual engagement has become a great way to continue patient participation without interruption. We’ve seen a lot of sponsors shift in-clinic visits to remote, or at-home, visits, leveraging our traveling nurses to help with data collection, tests, and assessments. We’ve heard positive feedback that conducting certain tests and assessments remotely has helped to shorten in-clinic visits. The result is that patients feel more comfortable coming to the site when they know it’s for a shorter visit.
As countries start to re-open, have you seen sponsors respond? Or is it too soon?
We’ve seen sponsors respond on a site-by-site basis. Certain sites may have had their areas utilized for COVID-19 patients and couldn’t accept new patients for the study. Others may be getting back to a new normal and are just now able to see patients again. Furthermore, some states have their own guidelines so it really has to be assessed on a site-by-site basis.
Do you think the measures that are being put in place in response to COVID-19 will last? Or do you think the industry will revert back to how things were done before?
I hope that they continue to be embraced and that the industry pushes their advancement. The industry has historically been slow to adopt change, but COVID-19 has pushed people to embrace change faster, as it was needed. So I hope the same effort is continued to be put into developing these new technologies and ways for patient participation to become easier. I feel optimistic that many of these new initiatives will continue to be embraced beyond COVID-19.