Clinical Trials
Why Clinical Trials?
We carry out clinical trials in order to evaluate the efficacy and safety of a particular treatment. This will provide valuable information in order to give patients the best possible care for their condition.
Why Inclusion and Exclusion Criteria?
In order to evaluate the effect of a treatment we need to make sure that the effect we see is only due to the treatment and not to any other factors. It is for this reason that we carefully choose the participants of clinical trials.
If a participant has a condition which then worsens during the trial, we will not know if this is due to the treatment, or their original condition, and it will therefore confuse our results.
Another consideration is the severity of the disease. In order to see an effect from the treatment, the symptoms must be measurable, so that a reduction in symptoms is clinically obvious. For this reason we ask that subjects have a minimum "symptom level".
These are is the bases for each trial having specific inclusion and exclusion criteria.
What is a blinded trial? Why randomise treatments? What is a placebo?
It is well known that a patient receiving any kind of treatment is likely to see an improvement, whether or not that product has a biochemical effect. This "mind over matter" phenomenon is known as the placebo effect. To evaluate whether the effect we see is entirely due to the specific treatment we randomise subjects to either a "mock" or placebo treatment (for example, an identical looking capsule to the "real" treatment). The gold standard for clinical trials is a "double-blinded" one, meaning that neither the subject nor the researcher is aware which treatment each individual is taking, until completion of the trial. We then look for the difference between these untreated and treated groups.