For Sponsors and Sites, the Research Restart Effort Begins With Communication
The COVID-19 pandemic has provided new proof of the research community’s resilience and collaborative spirit. Teams across the research spectrum have moved quickly to protect participants, staff, and communities from potential hazards.
At Advarra, we have heard from thousands of research sites seeking guidance on how to conduct safe and compliant research during the public health crisis. Sites have had to make many changes during the pandemic, and some may need to operate with limited staff and other resources for weeks or months to come.
As public health restrictions begin to relax and sponsors contemplate restarting pre-pandemic research activities, sponsors should consider how this “new normal” will impact plans to re-open research after COVID-19.
Assess Site Readiness Case by Case
Rather than sending generic communications to sites about restarting research, sponsors should consider contacting sites individually. Make an effort to understand how feasible restarting research is, what research is most likely to be sustainable in the near-term, and partner with sites to ensure a smooth transition with the safety of the entire research team (participants, site personnel, and sponsor staff) in mind.
Organizational changes have significantly impacted the research process, and unaffiliated or private sites may be ready to start up sooner than their academic and hospital colleagues. Sites that support both research and clinical care have significantly shifted priorities to focus on clinical care during the pandemic. The timing and ability of these sites to return to their clinical research programs will vary and may not change until safety and testing measures become more regular and stable. Some teams have had to temporarily or permanently reduce headcount due to financial constraints, which will impact site readiness.
With this in mind, sponsors re-engaging with research sites should be aware that everything will not be “back to normal” right away. Some questions to consider:
- When does the site expect staff will be able to return to the clinic or campus?
- Regional and state requirements, as well as individual organizational policies, will drive this decision. Each community has its own unique public health concerns, so assigning a blanket date for all sites to begin research activities likely will not work.
- What are the site’s current research priorities?
- Sites are managing competing priorities from sponsors and site leadership. Most sites probably cannot restart all their clinical trials at the same time or in the same manner. Research in certain diseases or conditions may need to restart before others.
- What new or revised organizational policies must the site now incorporate into their study conduct?
- Many sites never conducted remote or virtual consent discussions or study visits prior to the pandemic and may not yet have standard operating procedures (SOPs) in place to describe their processes. Sites have had to make rapid changes, and while they may now have experience with certain virtual activities, they may not be ready to add these as standard capabilities.
As you build out your plans, keep in mind some sites may be better equipped to permanently adopt virtual trial modalities than others. Unaffiliated/private sites may be able to adopt such technologies and process changes more quickly. Local public health restrictions may still hamper sites’ abilities to conduct in-person research activities like they did pre-pandemic, so sponsors should consider building in processes like remote subject initiation visits (SIVs) and remote monitoring.
Also note that sites of every stripe are working to document all the research changes made during the pandemic, adding additional work to ongoing research. In its guidance on conducting clinical trials during the COVID-19 pandemic, FDA recognizes “protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19…. Ensuring the safety of trial participants is paramount.” While FDA has allowed for necessary flexibility, such flexibility cannot result in decreased quality in evaluating the investigational intervention, or additional problems will surface downstream.
The global pandemic has changed the way we think about research, possibly forever. Some sites have discovered electronic and virtual study activities are more manageable than they previously assumed. Some sites may be struggling to figure out how they will come back from the COVID-19 crisis. Despite uncertainties as to what the future may hold, research standards based on ethics, risk mitigation, and data integrity remain.
The research community is understandably eager to get back to work, but it will likely take some time to get back to anything close to “normal”—whatever that means.
For more on sites and the COVID-19 response, read our blog How Sites Can Prepare for COVID-19 Genetically Engineered Vaccine Studies.