Horizons Clinical Research Center, LLC
Volunteering
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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 HCRC throughout the United States and from around the world must carefully conduct 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 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 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 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 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 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. HCRC conducts studies ranging from phase II to phase IV. Many different people participate in clinical research trials. Each 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 as a patient. 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 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 HCRC, 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 prescreening 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, and the patient’s identity is protected. If you are interested in one of our actively enrolling 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 asked to sign in. This is an FDA requirement and your name will be kept confidential. Once you have signed in 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 and signed the consent you are officially a participant in the study. |
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What is clinical research?
The research process
How new drugs are tested in humans
Participating as a study volunteer
Patient safety
Privacy
Volunteering as a patient for a clinical research study at HCRC
