According to Michele Russell-Einhorn, Chief Compliance Officer at Advarra, most research institutions had taken steps to partially or fully suspend non-COVID studies by March 18, 2020. As a result, research sites across the country saw a significant decrease in clinical research activities.
Despite causing disruptions, the industry rapidly responded to the unprecedented situation. Furthermore, the pandemic has sparked high levels of creativity and innovation among all the stakeholders (i.e., participants, research sites, sponsors, clinical research organizations), leading to solutions that can be used from here on out. For example, there has been an uptick in use of technology for virtual visits/telemedicine, completion of investigator assessments and remote data collection.
As we enter the fourth month of the crisis, sponsors are now getting ready to lift enrollment holds and initiate new studies. While we should expect an increase in clinical research activities, Dr. Wendy Tate reminds us that it is “unlikely that every protocol can be immediately opened to a pre-pandemic state.” Research conduct should also continue following the modified framework developed during the COVID era and we can continue to build on top of it. Because we have learned how to handle this stressful, unknown time, Dr. Tate believes we can now shift our mentalities from being reactive to more proactive. This means, sites, sponsors and IRBs should reflect on the lessons learned and amend operations, policies and protocols accordingly.
In deciding which studies should be re-opened, Dr. Tate recommends that both sites and sponsors create a prioritization process. This means looking at the entire portfolio of studies and assessing what trials are feasible at this time. As sponsors identify the studies that can be restarted or initiated, sites may find that they do not align with their own institution’s priorities or current capabilities. As such, it is important that sites think about the following before accepting a study:
1. Is this study easy to conduct?
2. If the study does not seem feasible, are there any small changes that can make the protocol more feasible?
3. What will the impact of conducting this study be on my site (including clinic space, staff and resources)
4. How will conducting this study affect the other ongoing studies?
5. Will taking on an additional study impact the safety of other participants?
As different stakeholders have different needs, Joan Versaggi, the Vice President of Consulting at Advarra, emphasizes the importance of communication. Versaggi advises that, “Conversations will need to be both upstream and downstream and that different mediums should be used to achieve the best fitting message”.
On the subject of a possible second wave, the IRB experts recommend that sites plan ahead by
- Creating a communication tree for each study protocol. The tree should include contacts from all participating organizations (e.g., research site, sponsor, central labs, IRBs, shipping/delivery).
- Ensuring that all site personnel are updated on all training (i.e., study specific, GCP, technologies).
- Establishing, reviewing and implementing policies or procedures that protect participants and manage study conduct during times of disruption.
- Identifying the successful changes made during the COVID period to create business continuity plans.
- Streamlining research processes to increase patient centricity.
- Understanding what changes need to be reported to the IRB.
- Building a positive attitude and culture about change.
- Sharing best practices with each other.
As we move into the next phase of clinical research during the pandemic, sites and sponsors will undoubtedly face new stressors and have to modify operations yet again. But, it is not all bad. “This is the time of disruptive innovation,” says Versaggi. “While the how is changing, the fundamentals of research remain the same.”
To learn more about prioritization processes and research in the new normal, watch the full webinar.
- Michele Russell-Einhorn, Chief Compliance Officer and Institutional Official at Advarra
- Dr. Wendy Tate, Director of Research Operations at Advarra
- Joan Versaggi, Vice President of Consulting at Advarra
- Judith Carrithers, Director of Regulatory Affairs at Advarra