The impact of COVID-19 on human beings around the world has been hard, immense and unremitting so far. The threat from this pandemic to people with acute or chronic medical conditions and weakened immune systems, such as cancer patients, is high. The FDA Oncology Center of Excellence has issued a statement in this connection, reaffirming its commitment to keep the unique needs of patients with cancer as a top priority. The National Cancer Institute has asked patients with cancer to follow the CDC’s advice on regular washing of hands and keeping hands away from touching one’s face. Other precautions include avoiding travel and crowds and staying at home as much as possible and keeping several weeks of medication and supplies available. Such additional actions are expected to help keep people, at high risk from developing serious complications from COVID-19, safe. Current Priorities: Here are the priorities laid out when working to address the critical issues being faced by this patient population:
- The need to coordinate with drug developers, academic investigators, and patient advocates to further the coordinated review of drugs, biologics, and devices for cancer.
- The need to document and approve any required modifications in clinical trials. In doing so, the FDA emphasizes minimizing the risks to trial integrity and promises to assist sponsors in assuring the safety of patients involved, keep patients informed of any changes that could affect them and ensure that compliance with good clinical practice is maintained.
- Requests for Expanded Access shall continue to be processed in order to make investigational therapies accessible to cancer patients when there are no other opportunities for the patient to enroll in a clinical trial.
- The FDA shall work to anticipate and prevent drug shortages that are critical to the treatment of patients with cancer, while continuing to inform the cancer community through regular updates.