The United States Food and Drug Administration (FDA) have released their guidance regarding conducting clinical trials for medicinal products throughout the current COVID-19 pandemic, to help support the safeguarding of trial participants throughout an ethically correct and legally compliant continuation of clinical trials.
Within their guidance, the following key considerations can be found:
- Patient safety is paramount
- COVID-19 screening should be considered
- Patient dosing or recruitment may need to be suspended
- Follow-up visits should be conducted by telephone, if no specific procedures are required for the visits
- If specific procedures are required, is an alternative possible?
- Consider how to manage and account for missing information
- Contact IRBs as soon as possible to discuss protocol changes
- Contact FDA if efficacy end-points or data management are likely to be affected
- All COVID-19 contingencies should be discussed in the CSR
In addition to releasing their guidance document, the FDA also released an additional statement – via their official website – where it was announced that, due to current circumstances, all domestic routine surveillance facility inspections are to be postponed; with the scenario of ‘mission critical’ inspections to be carried out following further assessment.
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