Clinical Trials Q&A

    What is a clinical trial?

    Although there are many definitions of clinical trials, they are generally
    considered to be biomedical or health-related research studies in human beings
    that follow a pre-defined protocol. BlackDoctor.org includes information on both
    interventional and observational types of studies. 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
    trial?

    Participants in clinical trials can play a more active role in their own
    health care, gain access to new research treatments before they are widely
    available, and help others by contributing to medical research.

    Who can participate in a clinical
    trial?

    All clinical trials have guidelines about who can participate. Using
    inclusion/exclusion criteria is an important principle of medical research that
    helps to produce reliable results. The factors that allow someone to participate
    in a clinical trial are called “inclusion criteria” and those that disallow
    someone from participating are called “exclusion criteria”. These criteria are
    based on such factors as age, gender, the type and stage of a disease, previous
    treatment history, and other medical conditions. Before joining a clinical
    trial, a participant must qualify for the study. Some research studies seek
    participants with illnesses or conditions to be studied in the clinical trial,
    while others need healthy participants. It is important to note that inclusion
    and exclusion criteria are not used to reject people personally. Instead, the
    criteria are used to identify appropriate participants and keep them safe. The
    criteria help ensure that researchers will be able to answer the questions they
    plan to study.

    What happens during a clinical
    trial?

    The clinical trial process depends on the kind of trial being conducted (See
    What are the different types of clinical trials?) The clinical trial team
    includes doctors and nurses as well as social workers and other health care
    professionals. They check the health of the participant at the beginning of the
    trial, give specific instructions for participating in the trial, monitor the
    participant carefully during the trial, and stay in touch after the trial is
    completed.

    Some clinical trials involve more tests and doctor visits than the
    participant would normally have for an illness or condition. For all types of
    trials, the participant works with a research team. Clinical trial participation
    is most successful when the protocol is carefully followed and there is frequent
    contact with the research staff.

    What is informed consent?

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