Data shows a majority of patients remain interested in clinical trials during the coronavirus pandemic.
The coronavirus pandemic has impacted clinical trial operations with unprecedented speed and severity. In order to gauge how the industry and the public are responding, our team at SubjectWell decided to make use of our connections to both research sites and patients. We set out to assess what adjustments sites have made to their operations, and how patients’ feelings regarding clinical trials are being affected by uncertainty around the impact of COVID-19.
We know that sponsors want to keep moving forward, especially at a time when clinical trial awareness is so heightened. Research sites want to continue conducting trials, and patients seem more than willing to participate – but both sides want assurance that doing so is safe and permissible.
So we went to work. We deployed surveys to patients and sites throughout North America between March 19 and 23, 2020. The surveys saw 468 responses from patients and 207 from sites. Patients ages 18 and older were surveyed, with 13% between the ages of 18 and 34, 55% between the ages of 35 and 59, and 32% over 60.
Here’s what we found.
51% of those surveyed have considered participating in a clinical trial.
- We consider this a positive sign, especially since clinical research awareness and education are at the core of what we do
57% of patients willing to participate in a clinical trial would do so within the next month
- However, 36% of those willing to participate were unsure of the time frame specifically due to the uncertainty around COVID-19
While the COVID-19 pandemic continues, patients were overwhelmingly in favor of services or choices that would allow them the flexibility to participate in a way that is most convenient for them.
- 61% were in favor of telehealth services
- 51% would consider participating if on-site safety measures were heightened, such as checking temperatures upon entering the office
- 53% would use electronic diaries for ongoing study compliance
- 48% were in favor of fewer office visits during this time
- 59% would be open to at-home lab collection kits
- 53% would allow at-home visits from qualified medical staff
- Only 22% reported not being comfortable participating in clinical research amid the pandemic
97% of sites expect to continue with ongoing studies.
- 67% will continue with existing studies and are considering new studies
- 23% will continue with existing studies, but at a limited capacity
- 7% will continue with existing studies only
54% of sites surveyed reported that they have not seen a change in patient willingness to participate in clinical research studies.
86% of sites are implementing measures to keep potentially infected patients at home.
83% of sites have protocols in place to keep potentially infected staff out of the office.
33% have contingency plans developed to deliver patient care at home if necessary.
47% are in discussion with sponsors and IRBs about potential protocol deviations.
We also received a fair amount of interesting anecdotal feedback from sites.
- Sites are vigilant about following CDC and WHO guidelines, as well as that from local authorities
- Most patients are being screened over the phone for COVID-19 symptoms before being approved to come into the research site for their visit
- Many sites have established 24/7 hotlines for patients to call with questions or concerns
- Across the board, patients are required to sanitize and have their temperatures taken before entering the site
- Many sites are limiting the number of patients allowed inside at a given time
- Sites are being extremely flexible about rescheduling appointments as needed
- Many sites are introducing telemedicine visits with their patients as visits allow
- Perhaps most important, sites recognize that patients likely have heightened emotions – so it’s critical to treat patients with empathy and respect
The industry’s response to COVID-19 is ever evolving, as are sites’ and patients’ attitudes. SubjectWell will continue these surveys at regular intervals and share data as it becomes available. The more we know about how sites and patients are attempting to traverse the current medical landscape, the more vigilant and nimble we can all be.
If you have any questions you’d like us to ask our marketplace, please reach out to us at email@example.com.
We’ll be back in touch as the coronavirus situation continues to evolve. Until then, please stay safe and healthy, everyone.