Pharmacy Daily | Patient safety critical for COVID cures

AUSTRALIAN and British pharmacologists are calling on researchers developing potential treatments for COVID-19 to adopt five core principles to ensure patient safety.

In a joint statement published in the British Journal of Clinical Pharmacology, experts from Monash University, the University of Sydney and the British Pharmacological Society, flagged concerns that many of the clinical trials, which are currently underway to develop a treatment for COVID-19 "do not include the information that is needed to safely translate a promising treatment from research to clinical practice".

Australian Society of Clinical and Experimental Pharmacologists and Toxicologists President, Dr Danijela Gnjidic, said the clinical pharmacology community was well placed to guide research for a cure.

"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," she 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."

British Pharmacological Society President, Sir Munir Pirmohamed, said the principles highlighted in the statement would "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," he said.

The five principles are:

The drug must work against the virus in cells or animal models at doses which are relevant for humans.

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.

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.

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).

Well-designed trials must be undertaken to show that the drug works in treating the disease and is safe.