COVID-19 is spreading rapidly, and its effects are creating many new challenges for clinical trials. Sites are being forced to reevaluate their procedures to protect participant safety and ensure continued engagement so trials can continue running. With so many changes occurring, continuous communication with all parties involved in the clinical trial is critical so that everyone has accurate and timely information.
Below are the 4 groups of people your site should remain in contact with during the progress of the COVID-19 pandemic:
1. Research Participants
It is essential for sites to communicate regularly with their research participants, especially during times of uncertainty. As COVID-19 continues to spread, there are a growing number of participants who have concerns about traveling to sites, where they have a greater risk of being exposed to the virus. To try to minimize these concerns, let them know what your site is doing to create a safe environment, including sharing any updated hygiene protocols.
It’s important for everyone who enters your site to follow the health recommendations outlined by the Center for Disease Control and Prevention. Post signage in restrooms on proper handwashing techniques, make sure employees have access to cleaning supplies and, if you have it available, offer hand sanitizer near the entrance of your site for employees and participants. While these tips might seem basic, good hygiene is the most important element in preventing the spread of COVID-19.
Your site also needs to communicate any changes to the trial that will impact your participants. Make sure you have current contact information in your CTMS patient database so you can let them know if their site visit is being cancelled or rescheduled, or if telemedicine options will replace in-person visits. There are also tools that offer two-way patient texting so your team can maintain constant and clear communication with your trial participants.
2. Institutional Review Board (IRB)
Protecting the welfare of research participants is every IRB’s main purpose, and sites are encouraged to communicate with their IRB if any emergent deviations to the protocol are required to keep participants safe from COVID-19. However, the situation is evolving rapidly and it may be necessary to make these changes without IRB approval if you need to eliminate an immediate hazard or protect a research participant’s life. All changes must be reported as soon as possible and you must include documentation on which participants were affected and how COVID-19 led to the changes being necessary. Participants should also be informed of the emergency changes that were made if they will be impacted by them, and the IRB can help determine if the changes are so substantial that “re-consent” is required.
Your site should also consult with the IRB to determine if it is in the best interest of the participants to continue with the trial. If a participant is unable to continue coming to the site, or if they no longer have access to the investigational product, they may need to consider withdrawing from the study. Any participant who withdraws might need extra monitoring, especially if they stop taking the study drug without the tapering process.
During the COVID-19 pandemic, sponsors will need to help sites find ways to minimize the risk of research participants being exposed to the virus. Work with your sponsor to reassess visits and procedures to create safe solutions that ensure as many participants as possible can continue the trial, even if they are not able to travel to your site. Some options include:
- Remove any unnecessary site visits.
- Replace site visits with at-home visits from nurses or other qualified healthcare workers
- Use alternate site locations that are either closer to a participant’s home or that lower unnecessary risk.
- Incorporate phone calls and remote check-ins for participants.
- Ship the investigational product directly to the participant’s home (or pharmacy) if deemed appropriate and is in line with state and federal laws. Sponsors can help advise on how to handle product accountability.
On-site monitoring visits by sponsors may also no longer be an option due to travel restrictions and quarantines. To prevent additional trial delays, sites can leverage eClinical software like eSource and eReg to enable sponsors to switch to remote monitoring and data verification. For sites without these tools, sponsors may ask for paper source to be scanned and uploaded to the cloud. If this happens to your site, be sure to request a budget amendment for your time.
Sites also need to be aware of the status of their trial. COVID-19 has caused many setbacks in clinical trials, and your site needs to know if your sponsor has put a pause on enrollment, delayed study startup timelines or if they made the difficult decision to halt the trial completely.
4. Other Sites
The spread of COVID-19 has created a large amount of disruption to the research site community. The vast majority of clinical trials are based on the traditional site-based/in-person model, but the virus has created a need to incorporate remote elements into the studies, forcing many sites into unfamiliar territory. Even though research can be competitive in some markets, it’s now crucial for sites to communicate with each other during this uncertain time and share recommendations for keeping sites running. Whether you have tips on virtual check-ins with patients, ideas on how to incorporate at-home nurse visits or even suggestions on where to cut expenses to save money, working together can help sites find ways to keep functioning and make it through this pandemic.