How to Find a Clinical Trial
What Questions Should You Ask?
If you find a clinical trial that interests you, feel free to ask many questions so that you understand as much as possible. Here are 13 useful questions, noted by ClinicalTrials.gov, to discuss with members of the health care team involved with the clinical trial:
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before? If so, in what phase is the trial (see below)?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow-up care is part of this study?
- How will I know if I get the placebo or the experimental treatment? Will results of the trials be provided to me?
- Who will be in charge of my care?
The 4 Phases of Clinical Trials
Clinical trials are carried out in phases, each with a different purpose. Here’s a description of the different questions that scientists try to answer during each phase:
Phase I:An experimental treatment is given to a small group of people (usually 20 to 80). The goal is to understand the best way to deliver the new treatment, check its safety, find a safe dosage range, and identify side effects.
Phase II: The drug or treatment being studied is given to a larger group of people (100-300) to test its effectiveness and to further evaluate safety. At this stage, there may or may not be a control group. People in a control group receive standard care but not the experimental therapy; people in treatment groups get the experimental therapy. A control group allows the researchers to compare the new therapy to other treatment, a placebo, or no treatment.
Phase III:The researchers give the experimental drug or treatment to large groups of people (1,000-3,000) to confirm effectiveness, monitor side effects, make comparisons to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. During this phase, there's usually a control group and a treatment group. People are randomly assigned to one of those groups; you can't choose which group you'll be in, and if there is a placebo group, you likely won't know if you're getting the placebo or the experimental therapy.
Phase IV:This research phase takes place after the study drug or treatment has received FDA approval. These post-marketing studies gather additional information, including the drug's risks, benefits, and optimal use in a larger population.