What Are First In Human Clinical Trials And Why Are They Required?

What Are First In Human Clinical Trials And Why Are They Required?

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What Are First In Human Clinical Trials And Why Are They Required?The advances in healthcare over the years have helped to ensure that patients can be treated for a wide range of ailments and diseases. Medical practitioners develop new drugs and treatments using a variety of means, with a common step in the process being clinical trials. These take place in medical facilities around the world and are the stage in the development of a treatment where its effect on human subjects is assessed.

Volunteering for a Clinical Trial

A clinical trial is essentially where a new drug or treatment is used on a study group of people to ensure that first of all it works as required in treating a disease and secondly that it is safe. It is generally a requirement for new drugs to gain a license for use and is also usually carried out when an existing drug is modified or improved.

A study group is typically made up of people that volunteer to take part. The age group and sex of volunteers will obviously depend on the treatment being assessed. The specific requirements will be identified in the study literature so that those considering applying will know if they qualify. The first stage in being accepted is generally a medical assessment known as a ‘screening test.’ Volunteers must pass this to make it to the study proper and doing so helps to ensure they are fit to take part.

Medical trials typically run for a time period of one to thirty days. Volunteers can receive payment for taking part and this generally depends on the duration of the trial. Payments can run from five hundred to three thousand pounds for participation and volunteers can also receive travel expenses of up to one hundred pounds to cover the cost of their journey to the medical facility. Volunteers are only permitted to take part in one trial at a time and on completion of this must wait for a period of at least three months before they apply to take part in another.

The fact that volunteers are being subjected to a new treatment means there is a slight risk involved. However, extensive study is carried out prior to clinical trials to ensure that any risk is minimal. Trials are also heavily regulated and the health of participants is closely monitored. For those that want to assist in the development of medicine, volunteering for a clinical trial is a way to do so.

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Written by Nick Davison, of Covance Clinical Research in Leeds.