What is a Clinical Trial?
Clinical trials (also called medical research and research studies) are designed to answer specific questions about drugs, new therapies or new ways of using known treatments. Clinical trials determine whether new drugs or treatments are safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work. Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and get promising results, they begin planning clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results.
Should I Participate in a Research Study?
If you're asked to participate in a research study, you'll want to learn as much as you can about it before deciding whether to participate.
Begin by asking:
- What is the purpose of this research?
- Who is sponsoring it?
- Who has reviewed and approved the study?
- Why do researchers think the treatment, drug or medical device being studied will work?
If you decide the study is worthwhile, you'll need to know what participating in the study will entail. You might ask:
- Where will the study take place? How often will I have to go to the study site?
- Will I be hospitalized during the study?
- How long will the study go on?
- What are my responsibilities during the study?
- What types of therapies, procedures and tests will I experience? Will they hurt? If so, for how long? How will therapies, procedures and tests during the study compare to those I might experience outside the study?
- May I receive my regular medications, procedures and treatments during the study? What medications, procedures, and treatments must I avoid?
- Will the researchers work with my doctor while I'm participating in the study? Who will provide my medical care after the study ends?
- Is participation confidential? May I talk to other people in the study?
- Will I learn the study's results?
Finally, you'll want to consider how participating in the study will affect your health and finances. Consider asking:
- What other treatment options do I have?
- For someone in my situation, how do the study's potential risks and benefits compare with those of existing treatments?
- What side effects - immediate and long-term - are possible as a result of participating in the study?
- Must I pay to participate in the study? If so, what are the fees likely to be? Is my insurance likely to cover those expenses?
What is Informed Consent?
The concept of informed consent requires researchers to:
- Provide potential participants with adequate information about a study
- Make sure that participants comprehend the information
- Make sure that participants give their consent voluntarily
Researchers must respect the rights of all participants in research studies.