27 May 2020
The COVID-19 pandemic has made plain the resilience and collaborative spirit of the research community. Teams from all corners of the research process have moved quickly to protect participants, staff, and communities from potential hazards. At Advarra we have heard from hundreds 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 social distancing measures and other precautions begin to relax and sponsors contemplate restarting pre-pandemic research activities, sponsors should consider how this “new normal” and the following concerns will impact plans to re-open research after COVID-19.
Changes to IRB Approved Research
In its March 2020 guidance on conducting clinical trials during the COVID-19 pandemic, FDA recognized that “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.”
This has led to many protocol modifications and deviations, and sites have understandably been concerned about appropriately reporting these changes. While the general guidance regarding such changes has been “document, document, document,” individual IRB reporting policies vary. Many IRBs have not required sites to report minor deviations, preferring only to review major deviations and permanent changes in the form of protocol amendments. This is separate from any sponsor-specific reporting requirements, which also vary study by study and sponsor by sponsor. Sites may be managing several sets of reporting requirements, which could complicate efforts to appropriately document the various changes.
Additionally, simply implementing these research changes has made potentially major changes to how sites operate. Many sites never conducted remote or virtual consent discussions prior to the pandemic and so may not yet have SOPs in place to describe the process. So too with shifting to remote or in-home visits to substitute for in-office/hospital/clinic visits—sites have had to make rapid changes to ensure safety, and while they may now have experience with certain virtual activities, they may not yet be ready to add these as standard capabilities.
Changes to the Research Process
Organizational changes have also impacted the research process. Sites that support both research and clinical care have shifted priorities to focus exclusively on clinical care during the pandemic. This focus may not change for many months, until a vaccine is approved, or other safety and testing measures are implemented in a sustainable means. Some teams have also had to permanently reduce headcount due to financial hardship. With this in mind, sponsors re-engaging with research sites should not expect everything to be “back to normal” right away.
Good Clinical Practice
International Conference on Harmonization (ICH) Guidelines give us Good Practices to follow in many aspects of treatment development. Practicing Good Clinical Practice (GCP) by confirming all changes made during this tumultuous time are clearly categorized, documented, and reported will ensure that the participant safety and data integrity are maintained. Despite all the changes needing to be made to ensure participant, patient, and staff safety, adhering to GCP allows the continuation of scientific evaluation and minimizes delays in the development process. 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 that 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 in ethics, risk mitigation, and data integrity remain.
Rather than sending generic communications to sites about restarting research, sponsors should consider contacting sites individually to understand how feasible restarting research really 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. 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.Print
24 September 2020
24 September 2020
23 September 2020
23 September 2020