Clinical trials are being impacted by the COVID-19 Pandemic. Challenges may arise, for example, from self-isolation, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administration or use of the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing.
FDA understands the crucial importance of human subject protections and clinical trial integrity, and the Agency has promptly provided information and answers to help promote both, see FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic. This guidance was issued on March 18, 2020, and then updated on March 27, 2020.
FDA is actively continuing its efforts to provide the clarity needed to help ensure the safety of clinical trial participants, maintain compliance with good clinical practice (GCP), and minimize risks to trial integrity during the COVID-19 pandemic by providing our stakeholders a single place to obtain guidance Clinicaltrialconduct-COVID19@fda.hhs.gov.
The FDA is coordinating the dissemination of information and recommendations from CDER/FDA to internal and external stakeholders regarding the conduct of clinical trials during the COVID-19 pandemic. FDA intends to ensure appropriate input and consistency of messaging, both within CDER and across centers, when responding to COVID-19-related inquiries from stakeholders, such that we are providing appropriate regulatory flexibility to ensure protection of human subjects and to promote trial integrity. And, FDA is maintaining a tracking system for inquiries and responses related to the conduct of clinical trials affected by COVID-19, allowing for real-time assessments and future analyses of lessons learned from conducting trials during a pandemic.
In conjunction with other CDER offices and centers, we will issue guidance documents on clinical trial conduct during the pandemic.
- FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- For more guidances on this topic and a comprehensive list, see COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders.
If you have additional questions on clinical trial conduct during the COVID-19 pandemic, please contact us at: Clinicaltrialconduct-COVID19@fda.hhs.gov.
FDA is making its MyStudies app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures.
More information on Coronavirus (COVID-19) related to drugs