FAQ

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  • What are Phase I, II, III and Phase IV clinical trials?

    Phase I These are first in human studies. They are usually small clinical studies conducted on healthy humans to study the safety as well as efficacy of the drug, safe dose range, side effects and how the body copes with assimilation, distribution, metabolism and excretion of the drug.

    Phase II These trials are larger than phase I studies and are conducted on patients to ascertain efficacy or show that the new product is as good as the existing treatment

    Phase III These are conducted on very larger number of patients and to check safety, efficacy and equivalence of new product to the existing products as well as ascertain the side effects based on a larger patient population in multi-center clinical studies.

    Phase IV These trials are conducted after the drug has been shown to work and approved for sale. These studies ascertain the long term impact on safety, side effects, risks and benefits in large segments of the user population.

  • 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 of 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 illness or a condition to be studied, while others need healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants and keep them safe.

  • What happens during a clinical trial?

    The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors, 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 participation, 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 others. 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?

    Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information to the participants. To help someone decide whether to or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then, the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures and key contacts. Risks and potential benefits are explained in the informed consent document. Informed consent is not a contract, and the participant may withdraw from the trial at any time

  • Can a participant leave a clinical trial after it has begun?

    Yes. A participant can leave a clinical study at any time. When withdrawing from a trial the participant should let the research team know about it, and the reason for leaving the study

  • What is clinical research?

    During a new drug’s early pre-clinical development, the sponsor’s primary goal is to determine if the product is reasonably safe for initial clinical research in humans and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as safe and commercially viable it moves on to the next stage of drug development. The drug is tested in humans by conducting Phase I through Phase III studies. Phase IV trials are conducted after a drug has been shown to work and approved for sale

  • What are the benefits and risks of participating in a clinical trial?

    Benefits: Best approach for eligible participants is to

    Play an active role in their healthcare.
    Gain access to new research treatments before they are widely available.
    Obtain expert medical care at leading health care facilities during the trial.
    Help others by contributing to medical research

    Risks

    There may be unpleasant, serious or even life threatening side effects to treatment.
    The treatment may not be effective for the participant.
    The protocol treatment may require more of their time and attention than would non protocol treatment.

  • How is the safety and privacy of a participant protected?

    The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings and in medical journals. However, they will not mention the participant’s name in these reports.

  • What should people consider before participating in a clinical trial?

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

  • Will you be compensated for you time?

    Volunteers may be offered compensation for their time and out of pocket expenses, and for discomfort that may be experienced during the trial. The amount of compensation is determined by the amount of time you will be required to dedicate to the trial.

  • What is the role of FDA or other health regulatory bodies in approving new drugs & medical treatments?

    The food and Drug Administrations’ and Health Canada’s job is to make sure that the medical treatments available through clinical trials are safe and effective for people to use. However, FDA does not develop new therapies, or conduct the clinical trials to demonstrate safety and effectiveness. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.

  • What is your role as study participant?

    If you decide to participate you will be asked to sign a consent form that explains the research being conducted in greater detail. You may also be asked to answer questions about your current and past medical and medication history. Every study would have certain specific numbers of visits with allowable time and days windows within which you will be expected to book and come in for you study visit. You would be expected to comply to study specific instructions or requirements or restrictions.

  • What types of assessments can you expect during your study visits?

    In order to ensure your eligibility and to monitor your safety and treatment progress, in the trial, a variety of trial specific examinations, testing and assessments would be performed like weight, temperature, blood pressure, measurements, blood and urine tests, skin prick test, ECG and breathing tests.

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