Clinical research is facing unprecedented challenges due to COVID-19. For ongoing clinical trials, the protection of patients, integrity of research data, and oversight of operations must be maintained as carefully as possible. We are working with each trial sponsor to evaluate risks and establish appropriate procedures and mitigations.
FDA has issued a recent guidance which provides several key considerations in the following areas:
- Study conduct should be modified, considering circumstances, to ensure patient safety. Continued recruitment, continued use of investigational items for existing participants, and continued monitoring should be examined to see if changes are needed, and participants should be informed of any potential impacts to them.
- IRBs may decide that changes or discontinuation of investigational items or participation is necessary.
- The supply chain that supports the trial, including provision and storage of investigational items and other trial-related products and services, may be altered.
- Trial participants may not be able to come to the study center for visits. Phone contact, virtual visits, or assessments at alternative locations may be necessary and should be used whenever possible to ensure patient safety. Safety monitoring in addition to what is specified in the protocol may be necessary if patients are withdrawn from treatment or if treatment is altered.
- Trial assessments may need to be delayed, ongoing recruitment may need to be halted, and procedures may need to be modified.
- COVID-19 testing may be required. Patients may acquire COVID-19 during the study, and related events and treatments should be documented appropriately in the study record.
- Protocol changes as a result of COVID-19 that are intended to protect safety do not require preapproval but should be reported afterward. IRBs should be informed and included prospectively whenever possible.
- Documentation is key: Reasons for changes to procedures, both study-wide and in regard to individual participants, should be recorded thoroughly, both citing reason and resulting impact. Missed visits should include specific information about what circumstances caused them. Efficacy endpoints can be collected by virtual assessments or alternate methods or can be delayed; reasons should be recorded.
- Statistical analysis plans and data management may need to be altered. Prior to database lock, changes should be assessed for impact and justified.
- Oversight through monitoring visits may need to be performed remotely.
Avania is in close contact with clinical trial sites to stay informed of rapidly changing current local policies and conditions. We are communicating with investigators and other study staff regarding availability of site resources, impact on patient visits, and about our access to clinical data, along with other relevant issues. We are informing IRBs and the FDA, in a timely way, of changes that modify protocols or relevant procedures. We are implementing remote monitoring, product accountability, oversight, and support wherever possible.
In close partnership with trial sponsors, we are crafting thoughtful and detailed trial-specific COVID-19 response plans. We are adapting all aspects of clinical operations in ways that maximize patient health and well-being and the scientific usefulness of the data gathered, while complying with all regulations and good practices.