Clinical Trials – How They Work

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Clinical trials are the process through which new medicines are tested to ensure their safety and effectiveness before being prescribed to the population. Every new drug is required by law to have undergone a process of testing before being licensed. It takes many years and millions of dollars/pounds/euros to take new medicines from the design to distribution and the clinical testing element of this process is vital.

In the early stages of this process data has to be gathered on the performance of a new drug in a variety of situations and testing on voluntary human participants is a key stage. There are two types of clinical trial a person interested in clinical testing can participate in. The first type is a condition specific trial.

Let’s say you have unfortunately contracted a cancer. You might be offered, as one option among many, the chance to participate in a trial that tests a new chemotherapy. Your Physicians may consider this a good option because the hypothesis is that the new drug is better than the old one. You will potentially receive benefits that you wouldn’t otherwise have had and the trial sponsor can collect vital data on the performance of the drug.

Condition specific trials exist for all manner of conditions, including simple skin problems, diabetes, asthma, conditions of the major internal organs, etc, all the way through to complex cancer and HIV treatments. If you are someone with a condition and wish to gain access to new treatments, your family doctor will be the first point of call.

The second type of trial requires healthy volunteers and looks at the effects of the drug on the parts of the body it is not intended to effect. Let’s say a company like GSK wishes to know if their new asthma treatment has any effects on the heart. They will set up a trial with healthy volunteers that will collect data on that specific question.

Drug companies require a large pool of healthy volunteers because each trial has different parameters and one volunteer who would be accepted onto one trial, may not be accepted onto another. Of course, this does not affect their chances of participating. It just means that the sample group of healthy volunteers has a pathology that falls within the parameters set by the sponsor.

Anyone applying to participate in any drug trials must give their informed consent. This means you have to have attended a consent talk and signed a form stating that you have been given all of the information about the trial, its protocols, the restrictions you must adhere to and any side effects you may experience before you begin the trial.

Trials that require healthy volunteers usually pay an honorarium for the time and commitment required to participate. Condition specific trials usually don’t pay their participants because they are being given access to new medicines they otherwise wouldn’t have encountered.

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