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Participating in Research

What you need to know.

By

Updated January 03, 2004

Changes in HIV care and treatment seem to occur daily. In just the last few months, three drugs, brand new or new forms of old drugs, have come onto the market. It's a complicated process to get a new treatment from the drawing board to your local pharmacy. For this to occur, there must be a system of clinical trials or research to make sure the medications and treatments work and more importantly do no harm. Eventually research needs to involve real patients. So what should you know before volunteering for a research project or drug clinical trial? There are several questions you need to ask before stepping forward.

What are the phases of a Clinical Trial?

Phase I: This stage marks the first introduction of a new drug into humans. The goal of this stage is to gage the actions and side effects of the drug in humans.

Phase II: This stage includes controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These trials usually involve a small number of subjects.

Phase III: This stage involves the administration of a new drug to a larger number of subjects in different clinical settings to determine its safety, effectiveness, and appropriate dosage.

Phase IV: This final stage is concurrent with marketing approval. The FDA may seek agreement from the sponsor to conduct certain post-marketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use.

What Questions Should You Ask?
Before entering any research or clinical trial, make sure you are well informed. Here are some questions you should ask before jumping in.

  • What is the study about?
    Make sure you know who is doing the study. Studies are usually sponsored by drug companies and are conducted in hospitals across the country. Make sure you know which doctor is in charge of the study in your hospital. Other questions you should ask are:

    • What is the purpose of the study?
    • What will be done with the results?
    • Is this study being done other places?
    • What do you hope to learn from the study?

  • Who put this study together?
    Again, make sure you know who is sponsoring the study and who is in charge of the study in your hospital. Also know who your contact person is if you have questions or problems during the study. Other important questions are:

    • Who are the researchers...scientists or doctors?
    • Have they done studies like this before?
    • Is the government part of this study?
    • Who is paying for the study?
    • Who will make money from this study?

  • Can I share ideas during the study?
    Find out if you will be allowed to provide feedback during the study. If you have questions or concerns, will they be listened to? In short, know how much you will be involved in carrying out the study. Other important questions include:

    • Who can I go to with ideas, concerns or complaints?
    • How can I find out how the study is going and what is learned from the study?

  • Who will be in the study?
    It's good to know what type of people are being recruited for the study. It's important to know how participants are chosen and who qualifies for the study. Other important things to know include:

    • Why are you looking for people like me?
    • Are people younger than 18 included in the study?
    • Will I have to pay to be in this study?
    • Who will pay for my medications, labs, etc.?
    • Can I quit the study after signing the consent?
    • Will my name be used in the study?
    • How will my confidentiality be maintained?
    • Will my care be affected if I do not qualify for the study?

  • What will I get out of the study?
    The age old question...what's in it for me? This is an important thing to know. Some studies provide cash payments, medicines, etc...some do not. Don't get caught off guard. Know what you are entitled to. Other questions include:

    • What are the benefits?
    • Is payment involved? How will I get paid?
    • If I am removed from the study, do I get payment for the time invested?
    • Can I still get the meds if I leave the study?

  • What are my risks? Could I be harmed?
    All medications carry the risk of side effects and adverse events. Know what these risks are and the likelihood you will experience one or any of them. Other issues include:

    • If I am harmed, who will take care of me and will treatments needed be paid for?
    • Do I have any legal avenues if I am harmed by the study?

Clinical trials are an important part of the advancement of HIV care. The study of new drugs and their effects, benefits, and problems when used in humans must be studied. Clinical trials offer valuable opportunities to HIV infected people who are looking for alternative or new treatments. But know what you are getting into before jumping in feet first. Again, knowledge is power and in the case of clinical trials, you can never know too much.

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