Research organizations worldwide are working to quickly adapt their clinical trials to the realities that COVID-19 has brought. Investigators and study staff are handling increased administrative burdens, as well as dealing with the ever-changing guidelines and patient questions.
Below are some best practices for how to retain current patients during the midst of a medical emergency.
Determine Remote Tasks
Technology is an important aspect of your clinical trial while most of the country moves to a remote work model. Research organizations should transition most of their administrative staff remote work as quickly as possible. Those staff members should have contact information for the Sponsors, CROs and enrolled patients, as well as any other information that they would need to conduct their job effectively. From there, those staff members can continue to schedule or reschedule necessary patient visits, as well as provide participants the information they will need for the study going forward. Tools like CTMS, and 2-way texting help streamline communications and can be accessed remotely via the web.
Develop a Communication Engagement Strategy
Communication is key – especially when guidelines change rapidly. Your sponsors should be communicating about the steps their sites need to take to keep their studies ongoing. Interactive webinars between sponsors and their sites would give sponsors the opportunity to address the concerns sites face and provide a platform to stay informed and ask questions. What’s more if you haven’t heard much from a study sponsor, don’t hesitate to contact them ASAP.
Your site team should also be reaching out to their enrolled participants to provide them with updates on the status of the trial. If anything changes regarding offices being closed, visit changes or the implementation of telemedicine, participants need to be made aware so you reduce the risk of additional delays or dropouts. Have your remote staff reach out to those participants through phone call, 2-way text or email to arm them with the appropriate information.
Protocol Amendments and IRB Approval
Once your research organization has developed its communication strategy, the next step is to start amending your protocol. All unnecessary visits must be removed from your protocol immediately in order to the reduce the risk participants face from encounters with staff and other patients. During this unprecedented time, your IRB is going to be your best source of information when it comes to submitting changes for approval. Remember, protocol deviations do not need to be reported to an IRB unless they negatively impact participants or will have negative impacts on an on-going study. For more information, be sure to read the recent FDA guidance for conducting trials during the COVID-19 pandemic.
The protocol amendments/changes that still need to be IRB approved are:
- The elimination or reduction in the number of study visits
- A shift from onsite to telemedicine or home healthcare
- The collection of labs off-site
Again, your best source information regarding protocol amendments is your IRB. Discuss your risks and options with them, and don’t forget to document everything!
If your clinical trial office is closed or is no longer conducting in-person visits, try and come up with new ways to keep your participants involved in the trial. Is there a way to conduct drive-up procedures? Can your research organization hire couriers or start a drive-by-pickup for any investigational products needed to continue in the study? In order to keep enrollment in your clinical trial, you’ll need to find ways to continue your protocol while adapting to the current CDC guidelines.