RESEARCH CLINIC

Clinical Research ...treatment with a sense of professionalism, respect, and excellence

Our Vision Our Vision is to become a partner in clinical research and development services which produce new drugs, medical devices, and treatments, and helping patients to improve their health and quality of life. Our Mission Our mission is to employ ethical standards using rigorous scientific and statistical methodologies that ensure the protection of human subjects and comply with GCP and IRB regulations in order to achieve quality results. Our Corporate Philosophy Research Institute of Greater Dayton empowers our team to "do the right things" and trusts that they will "do things right" the first time with passion, consistency, commitment, and a sense of urgency. Our Values Ethics and Intergrity Research Institure of Greater Dayton has an uncompromising commitment to the safety of human subjects and the quality of ethical reseach. We take very seriously the responsibility inherent in the transfer of obligations and confidential disclosure agreements between our company and or sponsors. We employ high-quality research methodologies that produce unbiased results. We are fastidious about the selection of the sponsored clinical trials and is obligated to immediately report any lack of compliance with Good Clinical Practices.

Facts about Clinical Trials What are differnt types of clinical trials? How safe are clinical trails? What are the benefits? What are the risks? What can I expect if I take part in a clinical trial? Should you participate in clinical research? Who can enter a clinical trial? Who pays for clinical research? How are experimental drugs tested in humans? How does a clinical trial work? Ten things to know about clinical trials.   There are four types of clinical trials: Treatment trials test new treatments, medicines, or surgeries. Prevention trials look for ways to prevent diseases using medicines, vitamins, vaccines, or lifestyle changes. Screening trials test ways to detect or diagnose diseases. Quality-of-life trials try to find ways to make life better for people living with a disease or health condition. How does a clinical trial work? Following are the four basic parts of a clinical trail: Basic Research. Before a clinical trial can start, doctors must have a theory about why a new therapy might treat a disease. It usually takes years of research to develop a theory. Animal Studies. Doctors first test the new treatment in animals to find out if it might be helpful or harmful to people. The Proposal. After the doctors involved in the study prove that the new treatment is safe in animals, a proposal is submitted to a group of doctors, statisticians, scientists, and people from the community who are members of an independent institutional review board (IRB). Each hospital or research center has its own IRB. It is up to the IRB to decide if the therapy is safe enough for testing in a small group of people. Finding Patients. After getting approval from the IRB, doctors must find patients for the study. All patients who take part in a clinical trial are volunteers. How are experimental drugs tested in humans? The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Once the FDA has granted a New Drug Approval (NDA), pharmaceutical companies will conduct post marketing or late phase three/phase four studies. Phase I Study: Phase I studies are primarily concerned with assessing the drug’s safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body- how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing. Phase II Study: Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second “control” group will receive a standard treatment or placebo. Often these studies are “blinded” where neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. Only about one-third of experimental drugs successfully complete both phase I and phase II studies. Phase III Study: In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug’s effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials. Phase III studies typically last several years. Seventy to 90 percent of drugs that enter phase III studies successfully complete this phase of testing. Once a phase III study is successfully completed, a pharmaceutical company can request for FDA approval for marketing the drug. Post-Marketing- Late Phase III/Phase IV Studies In late III/phase IV studies, pharmaceutical companies have several objectives: (1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug’s long-term effectiveness and impact on a patient’s quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Who Pays for clinical research? Funding for clinical research comes from both the federal government (through the National Institute of Health) and private industry (pharmaceutical and biotech companies). The sponsor of the research hires physicians, who may work in a wide variety of health-care settings, to conduct the clinical trial. Physicians are typically paid on a per-patient basis. The medical care is often provided free to the patient. Patients may also be paid a small fee to participate in a clinical trail. Who can enter a clinical trial? Every clinical trial has guidelines about who can take part. These guidelines are made up of a list of factors called inclusion and exclusion criteria. The inclusion and exclusion criteria are what help doctors produce accurate results. The factors that allow someone to take part in a clinical trial are called the inclusion criteria. The factors that prevent someone form taking part are called the exclusion criteria. Examples of inclusion and exclusion criteria are age, sex , the type of disease you have, your treatment history, or whether you have other medial conditions. Should you participate in clinical research? People participate in clinical research for a variety of reasons. People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free. The patient’s rights and safety are protected in two important ways. First, any physician awarded a research grant by a pharmaceutical company or the NIH must obtain approval to conduct the study from an Institutional Review Board. The review board, which is usually composed of physicians an lay people, is in charged with examining the study’s protocol to ensure that the patient’s rights are protected, and that the study does not present an undue or unnecessary risk to the patient. Second, anyone participating in a clinical trial in the United States is required to sign an “informed consent” form. This form details the nature of the study, the risks involved, and what may happen to a patient in the study. The informed consent tells patients that they hae a right to leave the study at any time. Patients considering participating in clinical research should talk about it with their physicians and medical caregivers. They also should seek to understand the credentials and experience of the individuals and the facility involved in conducting the study. What can I expect if I take part in a clinical trial? It is normal to be nervous about entering a clinical trial and feelings of being a “guinea pig”” are common concerns among patients. The exact process will depend on the type of clinical trial. You will get complete instructions about the clinical trial after you are enrolled, but here are some basics you can expect if you take part in a clinical trial. The clinical trial team will include doctors, nurses, social workers, and other health care professionals. You will most likely receive you care at a hospital, university, clinic, or doctor’s office. You will still see you regular primary care doctor or specialist even if you are going to the doctors involved in the clinical trial. The clinical trial doctor will examine you before you begin the study. You may find that you need more tests and doctor visits than you normally would. These tests will help the doctors follow your progress and collect the data they need for the study. You will need to follow the instructions for taking part in the study. For example, you may be asked to change the medicines you are currently taking or to change your diet or any activities that might affect the outcome of the study. You will be watched carefully during the study, and you will have to keep in touch with the clinical trial team. If at any time during the study you and your primary care doctor feel that you should leave the trial, you can. Even after the study is over, you will need to stay in touch with the clinical trial team for a certain amount of time. What are the risks? Because the treatment, medicine, or device being studied is new, doctors cannot know all of the risks and side effects at the start of a trial. The risks of a clinical trial would depend on the patient population and what is being studied. There may be bad or even life-threatening side effects. The treatment may not work. In randomized, double-blinded trials, neither the patient nor the doctor knows if the patient is receiving the new treatment, the standard treatment, or a placebo. In other words, you may not be getting any treatment at all. Remember, though, it is rare for any patient in a clinical trial not to receive any treatment at all. You may have to make many trips to the doctor, undergo a lot of testing and treatment, or even stay in the hospital. What are the benefits? Most people worry about the risks involved with a clinical trial, but there can be benefits as well. There may be bad or even life-threatening side effects. The treatment may not work. In randomized, double-blinded trials, neither the patient nor the doctor knows if the patient is receiving the new treatment, the standard treatment, or a placebo. In other words, you may not be getting any treatment at all. Remember, though, it is rare for any patient in a clinical trial not to receive any treatment at all. You may have to make many trips to the doctor, undergo a lot of testing and treatment, or even stay in the hospital. What are the benefits? Most people worry about the risks involved with a clinical trial, but there can be benefits as well. You may get a new treatment before anyone else does. For patients who have already tried the currently available treatment options, the clinical trial may be their last for hope for a new treatment. Clinical trials can save lives. These studies give doctors the information they need to keep developing new procedures and treatment methods that may help others in the future. Your treatment costs may be lower because many of the tests and doctor visits directly related to the clinical trial are paid by the study. (In some cases, there may be a cost to you, so be sure you know about any treatment costs before you enter a clinical trial.) You will be getting the best care from some of the leading hospitals in the world. How safe are clinical trails? Many people have fears about the safety of clinical trials, and they wonder if they are gambling with their health. For this reason, the US government has set up safeguards to protect people who decide to take part in a clinical trial. Understanding the safeguards that protect patients may help to ease some of your fears about clinical trials. Ten things to know about clinical trials: By participating in a clinical trial, you have access to the newest and most advanced treatments, before they are widely available. In a clinical trial, you are cared for by leading physicians in the field of cancer research. Before a new treatment is tested is tested in a clinical trial, it undergoes extensive laboratory testing, often for many years. Only the most promising new treatments make it to clinical trials. Patients decide to participate in clinical trials for many reasons, usually because they hope for a cure, a longer lifespan or an improved quality of life. By Ohio law, clinical trials are nearly always covered by insurance. Clinical trials are governed by protocols, or plans, that spell out exactly what will happen and why. Protocols are carefully reviewed to make sure they safeguard patients and have scientific merit. If it becomes clear during a clinical trial that one treatment is better than another, the trial is stopped so that all patients receive the treatment. The patients in the trial are the first to benefit. Placebos are sometimes used in clinical trials. Patient safety is first goal. All trials are conducted under strict supervision of specialist doctor. In a clinical trial, you receive close monitoring of your health care and any side effects. You can leave a clinical trail at any time, and choose instead to receive the best available standard care.