FDA appreciates the dedication of all patients who participate in clinical trials and recognizes that the COVID-19 pandemic has created many challenges. Many of us are practicing social distancing and are limiting our travel. Health care workers are caring for sick patients with COVID-19, and hospitals and other clinical care locations have limited resources. FDA is working with companies, hospitals, academic centers, and investigators conducting clinical trials to adjust to these challenges.
Below, FDA answers questions about how clinical trials may change during the COVID-19 pandemic to protect the safety of trial participants.
We recommend that you contact your clinical trial site and speak with the trial coordinator. This information is often found on your informed consent document. The trial coordinator will be able to provide you with information about upcoming visits to the study site and any other changes that might be planned for the trial. You should speak with your trial team before making any decisions about stopping or modifying investigational treatments that you are taking at home.
FDA is working with companies, hospitals, academic centers, and clinical investigators interested in exploring alternative approaches to monitor your safety during a clinical trial, including virtual visits, such as telemedicine. It might be possible for you to provide some information by phone or virtual visits. You might also be able to have lab tests done at a local lab. We are helping to ensure your safety while considering any alternative approach to your normal follow-up clinic visit.
We are working with companies, hospitals, academic centers, and investigators to understand and address the challenges that may affect your ability to receive investigational treatments. Your safety is our priority. We recognize that any decision to stop a clinical trial, even temporarily, might lead to you no longer receiving an investigational treatment. We know that this can be a difficult decision and FDA is working with companies and clinical investigators as they consider next steps. FDA recommends that you speak with your clinical trial site about your specific treatment and any changes that may be planned for the clinical trial.