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Sheet Number 204

PARTICIPATING IN A

CLINICAL TRIAL

Eslabón a la Versión Español

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WHAT IS AN AIDS

CLINICAL TRIAL?

Before new drugs can be sold to treat HIV disease, they must be

proved to be safe and effective. The Food and Drug Administration

(FDA) approves new drugs and other treatments based on the results

of laboratory tests, animal tests, and tests in humans (clinical

trials).

New treatments are tested in humans only if there were good

results from laboratory tests and animal studies. In the first

clinical trials, the treatment is tested for safety in a small

group of people. Later trials with many more participants test

how well the treatment works. InfoNet Fact Sheet 105, How

Drugs are Approved, has more information on the phases of

clinical trials.

A clinical trial is a carefully planned medical experiment.

The guidelines for a clinical trial are called a protocol. The

protocol is a document that describes exactly how the trial will

be carried out.

WHO CAN PARTICIPATE

IN A CLINICAL TRIAL?

The protocol explains the rules for participation in a clinical

trial. Each trial is different. For example, some trials require

certain viral loads or T-cell counts.

You normally cannot participate in a clinical trial if you

have any opportunistic infections, or are using any treatments

that might make it difficult to measure how well the test treatment

is working. You also cannot participate if the study treatment

might harm you. For example, women sometimes cannot participate

in trials during the first three months of pregnancy, because

of the risk of birth defects for their newborn child.

Trials are carried out at different hospitals and clinics throughout

the world. Some hospitals participate in many clinical trials.

Others may not offer any. Some trials will reimburse your travel

costs to a study center.

WHAT

ARE THE BENEFITS OF PARTICIPATING?

  • You could get a new treatment before it is available by prescription.
  • Your health will be watched very carefully.
  • You might get some or all of your medications paid for. You

    might also get some lab tests or other care for free.

  • You will be helping others by contributing information about

    new treatments.

WHAT ARE THE RISKS?

  • You might not get the new treatment. In trials, new treatments

    are compared to the best available medication or to a dummy medication

    (a “placebo”). Patients and doctors in these trials

    are not told who is getting the new treatment.

  • You might have to stop taking other medications during the

    trial.

  • Study treatments might not work.
  • Study treatments might have serious side effects.
  • Participating in a study might take a lot of time. It could

    require special record-keeping or many trips to the study location.

HOW ARE PARTICIPANTS

PROTECTED?

There are strict laws on research using human participants. The

main tool to protect you is called “Informed Consent”.

You will be given a full, written description of the clinical

trial to read and sign before you agree to participate. Take your

time to review the Informed Consent before you sign it. If you

need an interpreter to help you understand it, ask for one. If

you have questions, be sure you get the answers before you sign.

Also, there are local and national boards that review and monitor

each clinical trial before it starts and while it is in progress.

Trials can be stopped early if they are harming participants.

You can decide to drop out of a clinical trial at any time,

for any reason.

SHOULD I PARTICIPATE?

You and your doctor should discuss the possible benefits and risks

of taking part in a clinical trial. Here are some of the questions

you should consider:

  • What is the purpose of the study?
  • How long will it last?
  • Where is it being conducted?
  • How will I take the medication (pills, shots, intravenous

    infusion, other?)

  • What else do I have to do (records to keep, office visits,

    etc.)?

  • What will I have to pay for?
  • Can I be reimbursed for travel expenses?
  • Is child care available?
  • Will I be able to stay on the study treatment after the trial

    is over? Who will pay for it?

  • What was learned in previous studies of this treatment?
  • Will I have to stop any drugs or other treatments I am now

    using?

  • Will taking part in this study exclude me from other clinical

    trials?

TO FIND OUT

MORE ABOUT CLINICAL TRIALS:

  • For information about participating in clinical trials or

    trials availability throughout the US, call the AIDS Treatment

    Information Service (ATIS) at 1-800-TRIALS-A (1-800-874-2572).

  • The FDA Internet website has information on the drug development

    process at http://www.fda.gov/cder/handbook/dev_rev.htm

Reviewed October 18, 2002

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Partially funded by the National Library of Medicine

and the New Mexico Department of Health

This Fact Sheet is sponsored by the US Food and

Drug Administration (FDA)