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The Resource Train

Clinical Trials: Making Them Work for You

January/February 2004

Sarah Biel-Cunningham, MSW

In the early 1980s, when AIDS began to descend upon our community, fear was everywhere. Innocent people were dying and modern day medicine failed at saving lives. The medical community began working to improve what was available in the way of medicines to help those who were fighting this disease. It was known from the start that a cure may not be found right away, but researchers were driven by the fact that therapies could be discovered to restore health and slow the disease process. With these newly discovered experimental treatments came opportunities for individuals to partake in clinical trials to help test the validity of the newly developed drug therapies. A lifeline was born, and for the first time there was hope through access to new therapies not widely available. Lives were saved and the success of the clinical trials benefited the community through the approval of the first drug therapy in 1987, AZT. Clinical trials played an important role in the history of AIDS, but it is even more crucial to understand that clinical trials are just as important to this fight as they were 20 years ago. It is through clinical trials that individuals receive access to options, ultimately influencing the direction of drug therapies for the greater community. Ironically, many people are still unsure what clinical trials are and how one can participate in clinical trials. This is a brief overview of clinical trials and how to decide if participating in one is right for you.

What Is a Clinical Trial?

AIDS clinical trials are research studies in which new therapies for HIV/AIDS are tested in humans. Before new drug therapies can become available to the community to treat HIV, they must be proven both safe and effective. Clinical trials are designed to test these therapies on humans in order to provide results to the Food and Drug Administration (FDA) for approval. However, the first step is not to test in humans. New therapies are subjected to laboratory tests and tests that involve animals. If the results from these tests are good, the drug treatment is then moved into a clinical trial to be put through more testing involving human beings. Clinical trials are divided into three steps or phases. The first phase determines the treatments’ safety, which is assessed by using a small group of people. Phase two tests if the treatment works. Phase three assesses the long-term results of the treatment in humans.

Clinical trials are carefully governed medical processes based on rules and guidelines known as a protocol. The protocol describes what types of patients may participate in the clinical trial, schedules of tests and procedures, drugs and dosages, and the length of the study. The protocol describes exactly how the trial will be carried out. Participants in a clinical trial must agree to be treated by the terms of the protocol. This is part of the informed consent of the clinical trial, which is a tool developed to protect the participant within the clinical trial. By law, the researchers must provide you with a full written description of the clinical trial to read and sign before you agree to participate in the clinical trial. It is important to review all the information given to you and understand exactly what you are agreeing to within the clinical trial.

Who Is Eligible for Participation?

The protocol defines the rules for participation in a clinical trial and each trial is unique in the requirements for participation. Some trials are specifically designed with one gender in mind, others sometimes require your CD4 or viral load count to be at a certain level, and still others are geared towards people who are currently not on any drug therapies. There are many different opportunities available and if you are interested in participating in a clinical trial, talk with your physician to find out what is available for you.

What Are the Benefits of Participating?

  • Access to new treatments before they are available to the public
  • Access to medical care which monitors your health very carefully
  • The possibility of receiving some or all of your medications free of charge
  • Helping the community by contributing information about new treatments

Are There Risks to Being Involved in Clinical Trials?

  • The experimental drugs you have access to may not be effective.
  • During clinical trials, new treatments are often compared to already existing treatments or non-existent treatments, also known as a placebo. Participants do not have the option to choose which part of the clinical trials they participate in nor do they know whether they are receiving the new treatment or the placebo. Therefore, access to the new treatments is not guaranteed by the researcher.
  • You may be required to stop taking your already existing drug therapies that may be currently effective for you.
  • The new treatments may have unanticipated side effects.
  • The clinical trial you are participating in may require a lot of your time and frequent visits to the study site.

Should I Participate in a Clinical Trial?

Clinical trials definitely have the potential to not only benefit you, but also provide information to help the greater community. However, it is important to recognize potential risks associated with clinical trials. If you are considering participation in a clinical trial, you and your physician should discuss whether this is the best decision for your health. Here is a list of questions to consider when making your decision:

  • What is the purpose of the study?
  • What other treatment options are available to me?
  • Who will pay for the costs of the study?
  • How often will I have to go to the clinic?
  • What are the drug side effects?
  • What was learned in previous studies of this particular treatment?
  • Will I need to stop any drugs or other treatments I am in the process of using?
  • Can I be reimbursed for travel?
  • Where is the location of the clinic?
  • Is childcare available?
  • Will I be hospitalized for the trial?
  • Will I be able to stay on the study treatment after the trial is over?
  • How is my confidentiality protected?
  • Am I committed to staying with the clinical trial until it is complete?

How to Find Information on Clinical Trials?

The following resources are available to you:

National
AIDSinfo: www.AIDSinfo.nih.gov, 1-800-448-0440
AIDS Treatment Information Service: 1-800-874-2572

Metro Atlanta
AIDS Survival Project: (404) 874-7926
AIDS Research Consortium of Atlanta (ARCA): (404) 876-2317
Emory Clinical AIDS Research: (404) 616-6333

Author’s Note: The goal of this article is to provide a general overview of clinical trials and give resources to help you locate information about opportunities available. However, ultimately I would like to convey to all readers a sense of understanding of the importance of clinical trials and how crucial they are in the fight against AIDS, for without the hope provided through new developments, one could not even begin to imagine where we would be today.



  
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This article was provided by AIDS Survival Project. It is a part of the publication Survival News.
 
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