For successful COVID-19 treatments, pharmacological benchmarks are crucial: international statement

10 June 2020
An international group of leading pharmacologists is urging researchers to adopt drug development advice to ensure the result is safe for clinical use.

An international group of pharmacological societies has issued a statement calling for pharmacological expertise to be factored in as an essential for the safe translation of promising COVID-19 treatments from the lab bench to clinical practice.

The Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists and British Pharmacological Society have published a joint statement calling on researchers to apply clinical pharmacology principles in the search for safe treatments for COVID-19.

The statement was published in the British Journal of Clinical Pharmacology and endorsed by international organisations* across the world.

Experts from the University of Sydney and Monash University have led the global effort in Australia.

Currently more than 1000 clinical trials were under way related to the treatment of COVID-19 infections.

The statement welcomes international efforts to safely expedite clinical trials in the search for a treatment. However, it cautions that many studies do not include the information that is needed to safely translate a promising treatment from research to clinical practice.

The aim of this statement is to provide benchmark recommendations, organised under five major principles to help guide researchers who are publishing results, reporting results or developing clinical trials for potential COVID-19 treatments. 

Dr Danijela Gnjidic, from the School of Pharmacy, University of Sydney and President of the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, was one of the co-authors.

“The international clinical pharmacology community has much expertise to offer the COVID-19 effort. Clinical pharmacologists are experts in the development and use of medicines: the principles we use can help establish not just whether a drug will work but crucially, whether it will be safe,” Dr Gnjidic said.

“We hope that the principles outlined in this statement will help funders, researchers, media and policy makers navigate the known challenges of drug discovery and development.”

We hope that the principles outlined in this statement will help funders, researchers, media and policy makers navigate the known challenges of drug discovery and development
Dr Danijela Gnjidic

Five principles

  1. The drug must work against the virus in cells or animal models at doses which are relevant for humans.
  2. The amount of drug reaching the cells and organs affected by the virus must be adequate to either kill the virus and/or reduce inflammation.
  3. There needs to be a good understanding of how the virus infects and multiplies within the body and how this relates to the clinical features of COVID-19.
  4. The information from the above three principles should be used to define the optimal doses and duration of therapy (or therapies when more than one drug is used).
  5. Well-designed trials must be undertaken to show that the drug works in treating the disease and is safe.

Helping potential COVID-19 treatments be safer

Professor Sir Munir Pirmohamed, President of the British Pharmacological Society at the University of Liverpool and one of the co-authors of the statement, said:  

“This statement sets out principles that will ultimately help develop drugs that can be used for the treatment of COVID-19.”

“It is all very well if a treatment works in vitro – but if it cannot reach effective doses in the lung or other target organs, or if it is toxic, it will fail. Similarly, treatment with an antiviral only for a patient with severe disease as a consequence of a ‘cytokine storm’ may not be sufficient. We hope that this advice will help researchers embed clinical pharmacology principles at all stages of research, to help identify the right dose, for the right patient, at the right time.”

*List of endorsing organisations:

  • American College of Clinical Pharmacology (ACCP)
  • American Society for Clinical Pharmacology and Therapeutics (ASCPT)
  • American Society for Pharmacology & Experimental Therapeutics (ASPET)
  • Asia Pacific Federation of Pharmacologists (APFP)
  • Chinese Pharmacological Society (CNPHARS)
  • European Association for Clinical Pharmacology and Therapeutics (EACPT)
  • Faculty of Pharmaceutical Medicine (FPM)
  • Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT)
  • Japanese Pharmacological Society (JPS)
  • International Union of Basic and Clinical Pharmacology (IUPHAR)

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