International societies call on researchers to apply clinical pharmacology principles in search for safe and effective treatments for COVID-19

The Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists and the British Pharmacological Society have published a joint international statement calling on researchers to apply clinical pharmacology principles in the search for safe and effective treatments for COVID-19. The statement was published in the British Journal of Clinical Pharmacology and endorsed by organisations* across the world.

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.

Global

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

Professor Carl Kirkpatrick from Monash University’s Centre for Medicine Use and Safety said: “This statement sets out principles that will ultimately help establish whether a drug can be used effectively and safely for the treatment of COVID-19.

“Pharmacological societies from across the globe have come together in the hope that funders, researchers, media and policy makers will use the principles as a guide to implementing best clinical pharmacology practice at all stages of research, to help identify the right dose, for the right patient, at the right time.”

It sets out five principles that are intended to give research efforts the best chance of success to identify potential treatments:

  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 3 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.

*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)

Ends

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Kate Carthew
Monash University Faculty of Pharmacy and Pharmaceutical Sciences

M: 0438 674 814     E: kate.carthew@monash.edu