key: cord-0992679-za0rind0
authors: Pastino, Gina
title: Critical Need for Implementation of Clinical Pharmacology Principles in Developing Drugs for the Treatment or Prevention of COVID‐19
date: 2020-06-14
journal: J Clin Pharmacol
DOI: 10.1002/jcph.1690
sha: f335cd27ad90f84c57b773fecd06c888f3ed6ce8
doc_id: 992679
cord_uid: za0rind0

nan

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2 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 over 7.4 million confirmed cases and over 415,000 deaths worldwide, and no approved treatment or vaccine. 1 According to the COVID-19 Map of Hope, as of 11-June-2020 there are 2825 COVID-19 related clinical trials, of which 859 are classified as drug and 24 are classified as vaccine trial. 2 In addition, the data repository CURE ID developed by the U.S. 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. 3 However, the retraction of two recent articles 4,5 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. 6 The goal for 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 ASCEPT-BPS 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. 7 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 paediatric populations. The use of pharmacokinetic and pharmacodynamic modelling will be essential for all of these activities. Although the gravity of 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.

US Food and Drug Administration

Retraction: Cardiovascular Disease, Drug Therapy, and Mortality in Covid-19

Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis

Rigorous science: a how-to guide

A call for the appropriate application of clinical pharmacological principles in the search for safe and efficacious COVID-19 (SARS-COV-2) treatments