What are Clinical Trials?
Clinical trials are an essential phase in the development processes of a new drug and without them; new medications would never make it to the market. Many new drugs take a total of 10-15 years to reach this stage. As well as investigating new treatments at the Surrey Clinical Research Centre, we may also have studies involving approved prescribed medications, or have trials where no medication is involved where we are looking at other variables, such as sleep deprivation.
There are many stages in the development process of a new drug – these stages are divided into ‘Phases’. A new drug must be tested extensively prior to being made available to the public and has already been through many rigorous phases before reaching the human clinical trial stage.
Phase I studies usually include a small number of healthy participants. This phase is used to evaluate how safe a drug is, determine the required dose and identify any potential side effects associated with its use. A healthy participant is someone who does not need to take medication on a regular basis, and who has no on-going medical conditions or allergies.
Phase II studies involve more participants than Phase I and use participants who suffer with the condition the drug is designed to treat. During this phase researchers are looking at the effect of the drug on the condition. If this is successful a larger group of participants are used for Phase III studies. This phase evaluates and compares the drug’s effectiveness to a currently marketed drug which is already used to treat the condition.
Some studies may be called ‘blind’ wherein the participant does not know which product they are taking or ‘double blind’, meaning that neither the research staff nor the participant are aware of which product they are taking. The research may be looking at how the new study drug works compared to an existing medication or placebo drug. A ‘placebo’ is a dummy drug with no active ingredient.