Frequently Asked Questions

• What is a Clinical Trial?

  Clinical trials are considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol.

  • Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured.
  • Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
• Why Participate in a Clinical Research Study?

  Clinical research trials are needed to find new ways to prevent, diagnose or treat disease and are crucial to advancing medical research. Clinical trials can include testing new drugs or combinations of drugs, medical procedures or devices or advancing existing treatments.

  The outcome of a clinical trial is to determine if a new test or treatment is safe and to look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

  People participate in clinical trials for a variety of reasons, including:

  • The further advancement of medical science
  • Help others who are suffering from medical conditions
  • Get additional care from clinical research staff for a chronic illness they currently have
  • Access to investigational treatments before they become commercially available
  • Receive free physical examinations and diagnostic tests related to the clinical study
  • Ability to play a more active role in their own healthcare
• What should you consider before participating in a trial?

  As a clinical trial participant you should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

  • 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?
  • 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 that the experimental treatment is working? Will results of the trials be provided to me?
  • Who will be in charge of my care?
• What is a placebo?

  A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.

• What are the phases of clinical trials?

  Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

  • In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
  • In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
  • In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.