Clinical Research Trials: What the Patient Needs to Know

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Clinical Research Trials: What the Patient Needs to Know

Rheumatic diseases include a widespread number of conditions, which include

rheumatoid arthritis, osteoarthritis, lupus, fibromyalgia and gout. If you

suffer from one of these conditions you may be taking one or more

medications to treat your symptoms. Before medications are approved for use

they must undergo strict testing to be sure they are safe and effective.

This process is called a clinical trial.

A clinical trial is a research study done by physicians and health

professionals to assist in determining if a medication is safe and

effective. Before medications are given to patients, they must first be

studied and tested carefully. If beneficial results are seen, then a

research plan, known as a protocol, is constructed to study the medication

further.

Before a patient decides to participate in a clinical trial, they receive

detailed information about all parts of the study being conducted. Included

in this information are all the risks and side effects, as well as the

possible benefits. The physician, also known as the investigator, enrolls

patients and also oversees the care of the patient during the clinical

trial. The physician also must be sure that the information is understood,

including the rights of those participating in the study. This is called

informed consent.

Participants are then asked to read and sign a consent form. Contained in

this form is information about the possible benefits and risks of the

treatment, planned procedures the patient will undergo, and a list of other

available treatments. The participant should not sign this form until ALL

information is understood and until ALL questions have been answered.

Participation in a clinical trial is voluntary. Patients who do not wish to

be a part of a clinical trial will not be penalized in any way. Also,

patients may withdraw from a clinical trial at any time they choose.

Patients may benefit from an investigational medication or treatment long

before it is available to the public. During the trial medications, exams,

and laboratory tests may be received free of charge to the patient.

Participants in a study may help physicians and health care professionals

find a different and effective treatment for diseases.

In some cases, patients must stop taking their regular rheumatic medications

before the trial begins. This may induce a time of increased discomfort

until the new medication begins to work. Some trials require that a certain

number of subjects take a placebo. This substance looks like a medication,

but is essentially inactive. In most cases, neither the participant nor the

physician knows if the participant is taking a placebo or the medication

being investigated. In some instances, the medication being studied does not

work. If this happens the participant may choose to withdraw from the study.

As with many rheumatic medications, the participant may experience adverse

effects. These side effects may vary from person to person. Because the

medication being studied is new, the side effects may be unknown. Patients

considering being a part of a clinical trial should talk with the physician

about the known risks and the possible side effects associated with the

clinical trial.

Key Questions to Ask Before Entering a Trial

Can I continue to take my prescription or over-the-counter medications?

How many clinical trial office visits are required?

What is the purpose of the clinical trial?

How long will the trial last?

What kind of medication is involved and is it possible that I will receive a

placebo?

What types of procedures will be required?

How long will each visit last?

What will likely happen to my symptoms with or without the investigational

medication?

What other treatment options do I have and what are the risks and benefits?

What are the other treatment options available?

What are the possible side effects?