Horizons Clinical Research Center, LLC
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    Clinical research is the testing of new treatments or therapies in order to determine their safety and effectiveness in
    humans. Clinical research trials are an integral and very important element in the advancement of medical science.
    Progress in health care through the development of new methods of prevention, detection and treatment of medical
    conditions depend upon this type of research.

    Prior to a new drug being tested on humans it must first undergo years of experiments in animal and human cells
    and then extensive testing in animals. If this phase of testing is successful the pharmaceutical company then
    provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug in
    humans. The FDA requires that all new medications be tested on those people who have the medical condition that
    the medication is designed to treat. The FDA has imposed mandatory safeguards and regulations for the purpose
    of ensuring the safety of trial volunteers. Each clinical research study must follow a carefully constructed protocol
    which is a detailed written plan that is specific to that study and describes the need for the study, the purpose of
    the study, and how exactly the study is to be conducted. This protocol must first be approved by the FDA before a
    study can be initiated. Research sites such as Horizons Clinical Research Center, LLC throughout the United
    States and from around the world must carefully conduct research studies in strict adherence to the study protocol
    in order to assure accurate and standardized data from which the FDA will ultimately decide on whether or not to
    approve a new drug. Also as a further step to ensuring the safety of clinical study volunteers and the correct
    conduct of studies, an Institutional Review Board (IRB), which is an independent group of experts, must supervise
    and monitor each clinical trial. It is only after the required clinical testing has been completed that a drug is
    submitted to the FDA for approval.

    The clinical testing of new drugs is usually done in three initial phases, followed by post marketing or late phase
    three/phase four studies once FDA has granted a New Drug Approval. Each successive phase involves an ever
    larger number of people.

    Phase One Study:
    Phase I research studies are mainly concerned with determining the safety of a new drug. This first phase of testing
    involves only a few healthy volunteers, usually from 20 to 100, and is designed to assess what occurs to the drug in
    the human body: how it is absorbed, metabolized, and excreted. A phase I clinical trial will examine the side effects
    that occur as dosage levels are increased. Approximately 70 percent of experimental drugs pass this first phase of
    testing, which usually takes several months.

    Phase Two Study:
    While phase one determines the safety of a new drug, phase two tests its efficacy. This phase of testing may
    involve up to several hundred patients and last from a few months to two years. Most phase II studies will have one
    group of patients who will receive the experimental drug, while a second, and perhaps third, "control" group will
    receive an already FDA approved treatment or placebo. Usually in these research studies neither the patients nor
    the researchers know who is getting the experimental drug. This “blind” study is to prevent any subconscious
    influence the patient or the researchers might have on the results. Only about one-third of experimental drugs
    successfully complete the first two phases of studies.

    Phase Three Study:
    A phase III research study involves large-scale testing in several hundred to several thousand patients, and the
    purpose is to develop a more comprehensive understanding of the study drug's effectiveness, benefits, and the
    range of possible adverse reactions. Phase III studies often last several years and 70 to 90 percent of drugs that
    are tested in this phase successfully complete the testing. This is the final phase of testing before a drug can be
    submitted to the FDA for approval.

    Late Phase Three/Phase Four Studies:
    These late stage research studies are not required by the FDA but are conducted by pharmaceutical companies to
    obtain several possible objectives: to compare a proprietary drug with competitive drugs already in the market;
    monitor a drug's long-term effectiveness and impact on a patient's quality of life; and possibly to determine the cost-
    effectiveness of a drug therapy relative to other conventional and new therapies.

    Horizons conducts studies ranging from phase II to phase IV.

    Many different people participate in clinical research trials. Each clinical trial has very specific criteria that must be
    met by volunteers and some examples of these criteria are: gender, age, type of medical condition, prior
    medication/treatment, and severity of the medical condition.

    Clinical trial volunteers may have a number of different reasons for volunteering to participate in a research study.
    Many simply would like to help advance modern medicine, and their role as a study subject is vital in obtaining the
    knowledge to improve the health care for millions today and tomorrow.  Others desire to take a more active role in
    their own health care and participate in phase II and III studies where they may receive investigational treatments
    that might not be available to the general public for several years. Volunteers in all study phases also receive lab
    tests and medical exams free of charge throughout the study as well as expert medical care related to their health
    condition by highly qualified physicians. Typically volunteers also receive compensation for their time and travel.

    An Institutional Review Board (IRB), which is an independent group of experts, must supervise and monitor each
    clinical trial to ensure that a patient’s rights are protected and that the study does not pose any undue or
    unnecessary risk to the patient’s safety. Any and all volunteers who wish to participate in a clinical trial must also be
    provided with an informed consent statement that presents the details of the research study. These include the
    length of the study, what medical procedures there will be, possible medicine used, the number and frequency of
    visits, what will happen at those visits, the potential benefits of the treatment, and possible side effects. The
    informed consent also advises that the patient has the right to withdraw from the study at any time and for any
    reason. Prior to being included in a study the volunteer must sign the informed consent.

    The physicians and study coordinators at Horizons Clinical Research Center, LLC, as well as at any research site,
    are required to maintain a patient volunteer’s privacy at all times. Once a volunteer has passed the pre-screening
    process, has agreed to participate in a study, and has signed the informed consent, all necessary medical
    information is used exclusively for study purposes and is not shared with any other party not associated with the
    study, and the patient’s identity is protected.

    If you are interested in one of our actively enrolling research studies you can begin the volunteer process in
    several ways. The easiest and probably the most efficient means is to click on the link at the bottom of the study
    description page and complete the study questionnaire.  Include your name, e-mail address and phone number
    and a study coordinator will be in touch with you as soon as possible. She  may ask you a few more questions and
    then schedule your screening visit. You can also e-mail us or call us for more information.

    At your screening visit you will be  given the informed consent and given a quiet and private space to read it. When
    you have finished reading the informed consent a study coordinator/principal investigator will go over the consent
    with you and answer any questions you may have.  Once you have agreed to and signed the consent the official
    screening visit will begin.

    Horizons conducts studies that are for investigational medications that have passed the first human
    testing phase (Phase I) and may even have already received FDA approval and therefore in Phase IV.

    The Denver research studies that we conduct are for investigational treatments for such health
    conditions as:

            Type 2 Diabetes   
            Acne
            Psoriasis
            Overactive Bladder
            Gout
            High Blood Pressure
            Menopausal Symptoms
            High Cholesterol
            Type 2 Diabetes with High Blood Pressure
            Chronic Constipation
            Sun Damaged Skin (Actinic Keratosis)
            Eczema
            Osteoarthritis of the Knee
           Menopausal Hot Flash
            Irritable Bowel Syndrome (IBS)
            Oral Contraceptives
           Low Female Sex Drive

    Qualified study volunteers who participate in a research trial for any of these investigational
    treatments receive at no cost all study related:

            Medical care
            Lab assessments
            Medical exams   
            Investigational treatments
            Plus compensation for time and travel.

    Click here to see what studies may be enrolling new participants now or to learn if we may have a
    research study that is a good fit for you. We look forward to hearing from you!
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Information on clinical research and what it means to be a volunteer study participant.

What is clinical research?
The research process
How new drugs are tested in humans
Participating as a study volunteer
Patient safety
Volunteering as a patient for a clinical research study at Horizons
What type of studies does Horizons conduct?


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