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    What are Clinical Trials?

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    • What are Clinical Trials?

    What are Clinical Trials?

    Clinical trials are research studies performed on humans to help evaluate a new medical treatment, drug or device. The main purpose of a clinical trial is to discover new and improved methods for treating and preventing different diseases, illnesses, and more. To ensure clinical trials are conducted ethically and effectively, all clinical trials must abide by internationally recognized Good Clinical Practice (GCP) standards. GCP standards govern how clinical trials are to be conducted, performed, audited, and recorded. The GCP standards also ensure that each participant’s rights, integrity, and confidential information are protected during clinical trials.

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    Why Participate in Clinical Research?

    • As a volunteer, individuals can contribute to the overall advancement of medical science.
    • Clinical trials play a vital role in improving the overall health of current and future generations. Without volunteers, the discovery of new medication and medical practices would not be possible.
    • By participating in a clinical trial, individuals can receive financial compensation for volunteering their time.
    • Participants’ involvement can help millions of people around the world by contributing their time to clinical research.
    • If you are an individual with an illness or disease, your participation in clinical studies can grant you access to a new medication and/or methods for treatments that are not yet available to the general public.
    • As a volunteer, you can choose to participate in two different types of clinical trials: clinical or observational studies.

    Active Studies

    Clinical Research FAQs

    What Risks Should I Consider Before Joining a Clinical Trial?

    Before joining a clinical trial, it is important to do as much research on the study as possible. Discuss your questions and concerns with members of the healthcare team conducting the trial. You should also discuss the trial with your health care provider to determine whether the study is a good option of care based on your current treatment.


    For more information please visit:

    Are Clinical Trials Safe?

    The FDA works to protect participants in clinical trials by ensuring that volunteers have reliable information before deciding whether or not to join a clinical trial.

    The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.

    The government requires researchers to give prospective participants complete and accurate information on the exact nature of each step of a trial.

    Before joining a study, participants are given an informed consent document that outlines their rights as a participant, as well as giving them details on the nature of the study, including any potential risks.

    Benefits & Potential Risks of Clinical trials

    Benefits of  Clinical Trials

    • You may get a new treatment for a disease before it is available to the public.
    • It enables you to have a more active role in your health care.
    • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
    • You have the opportunity to help others get better treatment for their health problems in the future.
    • You may be able to get information about support groups and other resources.


    Potential Downsides of Clinical Trials

    • The new treatment could have potential side effects.
    • The treatment may not work as intended or may not be as effective as currently available treatments.
    • Participating in a clinical trial is a time commitment. You may be expected to stay overnight or for several days over the course of a trial. Patients who have signed an informed consent form may leave a trial at any time.


    What Information and Medical Tests are Required?

    The information and medical tests required will change depending on the Clinical Trial. Each study has different requirements. Some studies may have many tests while others may have almost none.

    During the screening visit (first meeting), participants are given an overview of the study and are asked questions to see if they meet the requirements outlined in the study Protocol (rules). Some of the most common tests performed and information asked for are:


    • Blood tests
    • A routine physical examination
    • Detailed Medical History


    Source: Uva Health

    How Many Visits are Required?

    A standard trial proceeds forward in several phases:

    1. A screening visit: During this visit, an informed consent document is reviewed with you, as well as your Medical History by the Investigational Staff.
    2. A baseline visit: When you attend this visit, the first step in your trial, you’ll receive your study medication and the dosing will be reviewed with you. (may be combined with the screening visit).
    3. A routine study visits Are periodic visits throughout the study that are done to track an individual’s progress during a clinical trial. The study team may:
    • Test bloodwork
    • Administer the study drug
    • Perform a checkup on your condition.

    Source: Uva Health

    Are any Lifestyle Changes or Restrictions Required?

    Personal lifestyle changes or restrictions during a clinical study depend on the protocol and the treatment being studied. In some cases, some treatments may have more restrictions than others.

    What are the Costs of Participating in a Clinical Trial?

    In some cases, taking part in a trial will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for drugs, devices, and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. The study informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you can ask a member of the research team to explain any costs to you before signing the consent form.


    Reimbursable & Compensation costs

    The following items can be reimbursed for participants:

    • Travel expenses
    • Accommodation
    • Loss of income

    What kind of compensation can participants receive?

    Compensation in regards to clinical trials can take many forms:

    • Participants can receive monetary or other benefits for their participation in the study
    • If participants receive a payment or other services when they suffer any harm from a clinical trial.

    Compensation is more common in Phase I trials with healthy volunteers. It is usually given to participants in recognition of their time and as an appreciation for their contribution to science.

    Source: EUPATI

    What Happens at the End of a Study?

    Researchers will analyze all collected data from the participants throughout the study. Information collected from each volunteer will be compared with data from other participants in the study. Doctors and specialists in biostatistics will conduct an analysis and report the findings to scientific groups and medical journals. Data will also be shared with experts and various government agencies responsible for the approval of new drugs, biologics, and devices.

    Source: Uva Health

    Can I Access my Data?

    You have the right to request your records from the trial investigator or the facility where the study was conducted. However, you may not be able to review or make a copy of your records until after the study has been completed. Clinical trial data is highly confidential. Before the study is completed, only select research staff, sponsors, review boards, and regulatory individuals are allowed to access trial data. Sharing patient data before completion can compromise the validity of the study in its entirety and jeopardize patient confidentiality and privacy. The trial doctor will let you know what information they can and cannot share with you before the trial is officially concluded.


    Source: Clinical Trials and Me

    Clinical Research Definitions

    What is a Protocol?

    A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will try to answer the research question. A protocol also states how the research team will protect the health and wellbeing of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.


    Source: EUPATI

    What is informed consent?

    Informed consent is the process that gives information to people who are thinking about taking part in research. After learning about the research, you should understand:

    • The purpose of the study.
    • The procedures involved in the study.
    • The possible benefits and risks of taking part in the study.
    • The rights of people who take part in research.
    • That taking part in research is your choice.
    • Alternative treatments available.
    • The right to be informed of any new information that may that might change your mind on continuing to participate.

    Informed consent is a process that helps you learn about the research study. After learning about the study, you will be able to ask the researcher or his/her staff questions. You should only agree to take part after you clearly understand the study and feel comfortable. You should take time to talk over your decision with your doctors, family, and friends. If you agree to take part, you will be asked to sign an “informed consent form.”



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