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Clinical trials

From Next steps • 1 December 2008

Your doctor might discuss the idea of participating in a clinical trialA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. . ClinicalPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science. trials are used to test the safety and effects of new drugs, combinations of drugs, and/or drug dosing strategies.

Before you agree to participate in a clinical trial, you should have adequate written and verbal information about the purpose of the trial, the procedures involved, the benefits and any potential risks. You do not have to agree to participate in a clinical trial even if your doctor recommends it. You have the right to decline and your standard of health care should not be affected if you decline.

Some of the reasons people might decide to become involved in a clinical trial include:

  • Participating in research has helped in Australia’s response to HIV/AIDS and led to advancements in the treatment of HIV/AIDS.
  • Participants may receive a new treatment before it is widely available.
  • Participants receive regular monitoring and other services at little or no cost.
  • The health of people participating in a clinical trial is closely monitored by HIV/AIDS experts who may have more knowledge or experience than their regular doctor.

Some of the things to consider before involvement in a clinical trial include:

  • New treatments often have unknown side effects or toxicities.
  • Some participants enter trials involving a placeboA dummy medical treatment, designed to have no pharmacological effect, administered to the control group of a clinical trial., meaning they don’t know until the end of the trial if they were getting the new drug or not.
  • The treatment may be helpful for a short period, but may not make any difference to long-term health.

Someone at your local AIDS Council or a local PLWHAPerson (or People) Living with HIV/AIDS. organisation might be able to discuss some of these considerations with you in greater detail to help you make a decision about whether or not to get involved in a clinical trial.

Next steps

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This Resource was first published on 1 December 2008 — more than five years ago.

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