• Frequently Asked Questions

    Answers to the questions we hear most.

    1. Why should I participate in clinical trials?

    If you want to be a part of finding new solutions to health problems, joining a clinical trial is one of the best ways you can help. If you're a patient with a health condition, you could potentially receive new treatments before they become widely available. You will also help advance our understanding of disease and how to treat it. Healthy volunteers who are critical for
    initial safety testing may be paid for their participation. Everyone who takes part in a clinical trial is playing an important
    role in making new medicines possible.

    2. How do I find out about clinical studies?

    Talk to your doctor or search a clinical study database such as ours. New trials are added regularly, so if you don't find one that is appropriate for you at first, keep checking. If you would like to get email updates on new trials relevant to you, sign up for our email alerts.

    3. Who can participate in a clinical study?

    Each clinical study has guidelines for participants based on specific factors, such as age, type of disease, medical history and current health. Depending on the study, researchers may seek healthy individuals or those with the particular illness under study. There are specific criteria for being included or excluded. For example, the trial may involve men who have lung cancer but have never smoked.

    4. Where are clinical studies conducted?

    Clinical trials are usually conducted at medical facilities such as hospitals and clinics. Phase 1 studies are typically held at a dedicated clinical facility. Volunteers stay at the facility throughout the study so they can be closely monitored.

    5. What happens in a clinical study?

    At its most basic level, a clinical study tests the effects of a potential new treatment on participants. Study participants receive potential treatments and doctors study how the treatment affects them. Some patients do not actually receive the test treatment, but instead receive a placebo (sometimes called a sugar pill - usually just a safe, inactive substance) or the current standard treatment as part of the "control" group. The progress of the participants is followed closely by doctors.

    6. What happens at a clinical
    study screening?

    The initial study screening is an opportunity for you to learn about the study and for the clinical team to learn about you. You are given information about the study to make sure you understand what is involved in the trial and your rights as a trial participant. A doctor takes your medical history, and you may receive diagnostic tests. If your health status matches the criteria for the study, you will be given the option to participate.

    As part of the screening and randomly throughout the trial, you may be tested for nicotine, alcohol and recreational drug use. You may also be tested for HIV/AIDS.All results will be treated as confidential. However, where applicable, positive HIV results must be reported to local health authorities.

    7. What questions should I ask before I agree to be in a clinical study?

    You have the right to ask any questions of the clinical trial team prior to agreeing to participate (a process called "informed consent"). Some questions you may want to ask include:

    • Has this drug been tested on humans before? If so, to what extent?
    • What is the purpose of the drug?
    • What are the possible risks?
    • Which company developed the drug?
    • Will any invasive procedures be carried out?
    • What type of samples will be taken and how often?
    • How long does the study last?

    8. What does "informed consent" mean?

    Informed consent means that clinical trial volunteers understand the details of their clinical study before agreeing to participate. Participants must be provided with all facts about a study, including treatment details and possible risks and benefits. They must sign an informed consent form before they begin a study. In addition, participants must be kept informed throughout the clinical trial.

    9. How long do clinical trials last?

    Phase 1 studies typically last between one and two weeks. In some studies, periodic visits are required, typically over longer periods. Phase 2, Phase 3 and Phase 4 studies can last several months to several years.

    10. How do drugs get approved?

    Each country has a regulatory authority over medications. In the U.S., the Food and Drug Administration (FDA) is charged with overseeing the safety and effectiveness of all prescription medications marketed in the United States. In Europe, it is the European Medicines Agency (EMA). Before the
    regulatory authority gives approval to the drug company to market a medicine, it considers two primary points: 1) whether the clinical studies provide substantial evidence that the medication is effective and 2) whether the medication is safe under the conditions outlined in labeling. Ultimately, the consideration is whether the benefits of the medication outweigh its risks. For life-threatening diseases, there are mechanisms to accelerate the approval process so the treatment can be available to patients sooner.

    11. Will my insurance or provider pay for the clinical study expenses?

    Not always. Make a point to find out upfront whether your health insurance or managed care provider will cover the costs of a particular clinical study. Speak with one of the clinical trial's doctors about cost issues before you agree to volunteer as a participant.