Clinical Trials in the COVID-19 Era: A breakdown of FDA Guidance and Future Considerations

Abstract

Clinical trials that involve medical products are critical to advancing treatments in any medical field and are designed with careful thought and attention to detail. These details include careful assessment of safety parameters from patient safety visits, lab work and deliberately placed screening parameters. Meticulous planning for primary, secondary and correlative outcomes is completed by the study team and the biostatisticians involved in each study design. These precise measures are then methodically written as a clinical trial protocol and submitted to regulatory bodies such as the Food and Drug Administration (FDA) often as an Investigational Drug Application (IND) and also submitted to the Institutional Review Board (IRB) so that a study can have the appropriate regulatory approval to be tested for the desired outcome. The Principal Investigator (PI) and study team are required to follow these protocols and regulatory requirements with exactitude to maintain clinical trial integrity. While there are many models projecting variances in the timeframe of this pandemic, it is very possible that these modifications will be in place for months/years to come in varying intensities, so it is imperative that we understand them if we participate in clinical trials moving forward.