Why are clinical trials needed?

The medical world cares about the human condition. That's why researchers constantly look for better or new ways of treating illness and disease. But their discoveries can not be put into general use until controlled testing has been done on actual patients.

Clinical trials are the only way that testing can be done. The Food and Drug Administration (FDA) requires clinical trials before it can approve a drug for public use.

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Who conducts clinical trials?

Pharmaceutical companies, research institutions, or other health organizations may be the sponsor of a clinical trial. They are responsible for funding and for designing its protocol. A protocol is a set of detailed guidelines that clinical investigators follow in order to conduct the same clinical trial at several different locations.

Although pharmaceutical companies sponsor a clinical trial, only trained doctors, nurses, and medical researchers actually conduct the trial itself.

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Why should I participate in a clinical trial?

Two reasons: to help yourself and to help others.

It's possible the treatment being tested will improve your health. An investigational drug or procedure may reduce pain or treat your illness.

You may also decide to participate in a clinical trial for the satisfaction that comes from being a part of scientific research. Every day, there are people hoping for a breakthrough treatment that will make coping with an illness easier or eliminate it altogether. Clinical trial volunteers help make those discoveries available to people all across the country and around the world.

Remember: Deciding whether or not to participate, or to continue to participate, in a trial is up to you.

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Who is eligible to be in a clinical trial?

Every clinical trial attempts to answer some very specific research questions. To do this, each trial has certain requirements about your health, medication, age, and other things. You must meet the requirements of a particular trial to be an eligible volunteer. Ask your doctor or nurse about the eligibility requirements for a particular trial.

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What is a clinical trial like?

Participating in a clinical trial is much like a regular visit to a hospital, medical clinic, or doctor's office, but includes specific requirements of the protocol (research plan). The success of any trial depends on its volunteers.

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What are the risks?

Risks vary from trial to trial. No one can say with certainty what the risks of a particular trial might be. Although researchers expect certain results from each trial, the fact that a treatment is still being studied makes it impossible to rule out side effects or adverse reactions.

It is possible that some side effects could be permanent or even life-threatening. Most side effects are temporary and will go away as soon as the treatment is stopped.

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What is needed of me?

Your first responsibility is to fully understand your commitment to the trial. The trial investigators and sponsor need you to be at appointments on time, to follow their instructions carefully, and especially to take any medication exactly as told. They need you to take the trial seriously. Your full cooperation and participation is needed if the investigators are to collect the information they must have for a successful study.

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What can I expect from the clinical trial team?

More that anything else, you have the right to expect complete information about the trial. Don't participate in any clinical trial unless your questions have been reasonably answered.

You will be given an informed consent form to read and sign. This is required by law to make sure you understand what is involved in a trial. It should include an honest discussion of potential risks and benefits. You should also expect complete information about the schedule and duration of the trial location, and the name of someone you can contact with questions or problems.

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How am I protected as a clinical trial patient?

Informed consent helps protect you by making sure you have been given all the necessary information about a trial. The FDA regulates clinical trial advertisements to reduce misleading claims. It also requires an institutional review board to review the general progress of the trial.

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What to ask your doctor before participating in a clinical trial:

• What is the purpose of the trial?
  
• What treatments will be done and how?
  
• How is patient safety going to be checked?
  
• What are the possible side effects and risks of treatment?
  
• How could this treatment benefit me?
  
• Other than the one being tested, what treatments are available for the same condition?
  
• How will the trial affect my daily life?
  
• How long will the trial last?
  
• Where is my trial being done?
  
• Who is sponsoring the trial?
  
• Will I have to pay for anything?
  
• What happens if I am harmed by the trial?
  
• Will I be able to stay on this treatment when the trial is over?

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