5 FAQ's About Clinical Trials

Doctors are always researching new ways of treating chronic conditions like varicose veins. Researchers use clinical trials to test these new treatments before seeking American FDA or European (CE) approval. Currently over 50 clinical trials worldwide are recruiting volunteers for new procedures and treatments for varicose veins and other vein conditions.

What Is A Clinical Trial?

In a clinical trial, researchers, surgeons or pharmaceutical companies test a new procedure or drug on human volunteers after testing it in the lab. Depending on the type of trial, volunteers may be healthy or may have the disease or condition the treatment is supposed to relieve. Many trials use a 'control group' in addition that only receives a 'placebo' pill or 'sham treatment'.

What Is A Placebo?

To see if the new treatment is effective, doctors give the control group participants a placebo, for example a sugar pill, or conduct a 'sham' treatment. Because about 30% of patients respond to any type of treatment, even an inert sugar pill, commonly called the 'placebo effect', a medication or procedure has to be more effective than a placebo. To see if this is the case, researchers conduct 'double-blind' trials.

What Is A Double-Blind Trial?

Double-blind trials are where neither the volunteer patient nor the doctor administering the treatment knows whether the person is receiving the real treatment or the placebo. This is because if the doctor knew who was getting which treatment, they could inadvertently influence the trial results by the way they interacted with the patient. This is called the 'observer effect' or 'observer bias'. In a double-blind trial, the participants are matched against certain criteria and then the group is divided into two, usually at random. One group is assigned the treatment and the other, the 'control group' just receives the placebo.

Are There Other Types Of Trials?

Yes, there are various types of clinic trials. At the beginning of the testing process researchers use small-scale trials while at later stages they run large-scale trials which need a lot of participants. Clinical researchers may run a variety of treatment trials using different doses of the same medication, to see which dose is the most effective. Other trials compare the effectiveness of the new procedure against an existing procedure. An observational trial just observes a particular condition to gather data without giving any treatment.

Some trials may be 'single-blind' trials where only the patient doesn't know if they are receiving the treatment or the placebo. In a 'cross-over' trial there may be more than one drug being tested with the drugs switched half way through the trial. Both test groups receive both drugs, or the drug and a placebo but in a different order.

Are There Any Risks?

There are always some risks for some people when taking medication or having procedures, even when they have FDA approval. This is especially true when researchers are testing drugs or procedures. When you take part in a clinical trial, the researchers will be careful to explain the risks, so far as they are aware, and will ask you to give them any feedback, positive or negative regarding the treatment.

Participating In A Trial

One of the advantages of participating in a medical trial is that you may receive the treatment for free, and in some cases volunteers are even paid for their participation. To find out more about participating in a clinical trial for varicose veins, consult your family doctor or vein specialist to see if there are any trials in your area that are recruiting volunteers.