Critical Need for Implementation of Clinical Pharmacology Principles in Developing Drugs for the Treatment or Prevention of COVID-19.

That there is a critical need for safe and effective treatment of COVID‐19 disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) is indisputable. There have been more than 7.4 million confirmed cases and more than 415 000 deaths worldwide and no approved treatment or vaccine. According to the COVID‐19 Map of Hope, as of June 11, 2020, there are 2825 COVID‐19=related clinical trials, of which 859 are classified as drug and 24 are classified as vaccine trials. In addition, the data repository CURE ID developed by the US Food and Drug Administration and the National Center for Advancing Translational Sciences allows clinicians the ability to report novel uses of existing drugs for patients with difficult‐to‐treat infectious diseases such as COVID‐19. However, the retraction of 2 recent articles , on experimental treatments with drugs already approved for other indications underscores the need for application of rigorous scientific principles in the quest to seek new drug therapies.

The goal for the development of any potential drug for the treatment of COVID‐19 disease should be grounded in the fundamental principles of clinical pharmacology, that is, to seek the right drug, for the right patient, at the right dose, to be given at the right time. Indeed, a fundamental understanding of the clinical pharmacology is required for safe and effective treatments for any indication.

As such, the American College of Clinical Pharmacology endorses the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists‐British Pharmacological Society joint statement on COVID‐19 (SARS‐CoV‐2): a call for the appropriate application of clinical pharmacological principles in the search for safe and efficacious COVID‐19 treatments. As outlined by the authors, it is critical to understand the concentrations that demonstrate activity against SARS‐CoV‐2; to identify the optimal dose and dosing regimen as informed by adequately sized, randomized, controlled clinical trials; to understand the potential drug‐drug interactions, especially given the nature of the comorbidities and concomitant medications in those patients; to collect the necessary safety data across all populations; and to identify the need for alternative doses or dosing regimens in susceptible populations, most importantly in the elderly and pediatric populations. The use of pharmacokinetic and pharmacodynamic modeling will be essential for all these activities. Although the gravity of the COVID‐19 pandemic warrants an immediate and aggressive search for effective and safe treatments, not adhering to the fundamental principles of clinical pharmacology will likely cause more harm to patients in the end.