The stages of drug trials

 
 

The process of creating drugs in a laboratory to being able to purchase them over the counter is a long one. Sometimes it can take a period of over ten years to complete all the testing stages.

Before a drug is tested in humans, it would have been through laboratory and animal testing. It is mainly rodents who these drugs are tested upon generally to check for any toxicity before they are tested in humans.

After being cleared for human testing by the relevant ethical bodies, the drug undergoes three main stages of testing. Phase one is a safety test where a small number of people, sometimes healthy, and sometimes with a medical condition, are given a tiny dose of the drug under careful supervision, not to test if the drug works, but in order to check for any possible side effects.

Phase two is where the drug is administered to people who have the relevant condition to see if it helps them. The final stage, Phase three, is a large-scale study usually involving tens of thousands of people.

Participants are often randomly allocated to either get the drug or a dummy version. In most cases, neither the scientists nor the patients know who has got the real drug so that the results cannot be skewed by expectations.

Before any trials commence, participants are told what risks are involved and what the known side effects might be. They would also be told what compensation would be in place if something unexpected went wrong.

Such research can require people to spend two or three weeks in the research unit, so many of those taking part are students. However women of reproductive age would not be involved if there was any chance they were pregnant, in case there were effects on a foetus.

– Quinton O’Reilly

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