What Is A Clinical Trial And How Does A Clinical Trial Work?

A clinical trial starts with a drug or treatment and a "protocol" -- guidelines that are to be followed in the delivery of the drug or treatment which include:

• Dosage amount and when delivered.
• Length of time for the trial.
• Markers to be checked.
• Symptoms to be watched for.

In order to determine the effectiveness of the drug or treatment being tested, what happens in people who are taking the drug or treatment is compared to people who are doing nothing or taking a standard treatment.

With most clinical trials, this is accomplished by dividing the participants in the trial into two groups: people who will receive the new drug or treatment and people who won't. The second group either continues with a standard drug or treatment or is given a placebo basically a sugar pill that looks like the drug being tested.) Placebos are not generally used in studies involving people with a life-threatening health condition. All participants enrolled in studies that use placebos are informed in advance of the possibility of receiving a placebo rather than the experimental treatment.

The team that actually conducts the trial will include doctors, nurses, other health care professionals, and often social workers. They will:

• Check your health at the beginning of the trial.
• Provide you with specific instructions for participation.
• Monitor your health during the course of the trial to determine the safety and effectiveness of the treatment.
• Possibly stay in touch with you after the study - usually to monitor long term effectiveness and safety.

For all types of trials, you will work closely with the research team.

The time and commitment requirements for participation in a study can vary greatly, depending on the trial. Commitment requirements are generally greater than the requirements for standard treatment. Some clinical trials require more testing or monitoring and possibly a greater number of doctor visits or hospitalizations than you would normally have for your illness or condition. Some trials may also include complex medication dosing schedules.

It is important that participants follow the treatment protocol carefully.

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