Guidelines for Safe Clinical Research  During a Pandemic

The Food and Drug Administration (FDA) is essential in protecting the United States against dangers such as new infectious illnesses, such as the Coronavirus Disease 2019 (COVID-19) pandemic. The FDA is dedicated to providing timely recommendations to assist in the pandemic response. For the length of the COVID-19 public health emergency, the FDA offers this guideline to help sponsors ensure the safety of trial participants, preserve compliance with good clinical practice (GCP), and avoid risks to trial integrity.

• The unexpected appearance of the COVID-19 pandemic wreaked havoc on the healthcare system, supply chain, economy, and social interactions throughout the world. Clinical research has been suspended or terminated in certain areas due to the pressing demands of patient care. Clinical trials focusing on the treatment and prevention of coronavirus infection were given priority over other research. To improve future preparedness, examine ethical problems in decision-making and competing ethical pressures during the epidemic.

• Creating and delivering safe and effective diagnostic, therapeutic, and vaccination products are critical to a population’s health, procedures that rely on clinical trials as part of well-organised product development programmes. The clinical research community was unprepared for the disruption created by the COVID-19 pandemic, which has had a global impact on operations and trial conduct. Changes have been made quickly to emphasise patient and participant (as well as healthcare professional) safety and meet the need for social distance to reduce the virus’ transmission. These modifications—clinical trial suspensions, terminations, and continuations—were made after quickly assessing whether risks could be declined and trial and data integrity could be ensured. Examine the ethical issues that arise during pandemic decision-making to improve preparedness and learning. Separate judgments about existing clinical trials from decisions about whether and when to start new studies by analysing required trade-offs.

References

Bierer, B. E., et al. “Ethical challenges in clinical research during the COVID-19 pandemic.” Journal of Bioethical Inquiry 17.4 (2020): 717-722.