The Christ Hospital offers clinical research study participation opportunities to our extended community. The research department was founded over 20 years ago and remains a thriving facility focused on education, hope and discovery.
What is clinical research? Most commonly, clinical research refers to new drug testing. Before a pharmaceutical company can initiate testing in humans, it must conduct extensive preclinical or laboratory research. This research typically involves years of experiments in animal and human cells. If this stage of testing is successful, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to begin testing the drug in humans.
The clinical testing of experimental drugs is normally done in three phases, each successive phase involving a larger number of people. Very few of the drugs tested are granted a New Drug Approval by the FDA, which may then be accessible by the public.
Phase I studies are primarily concerned with assessing the drug’s safety. This initial phase of testing 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.
Once a drug has been shown to be safe, it must be tested for efficacy or effectiveness. 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,” which means that 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.
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 FDA approval for marketing the drug.
- Late Phase III/Phase IV Studies
Often termed “Post Marketing Studies,” in late Phase 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.
Frequently Asked Questions
Why is research important?
Without research medications, patient drugs, treatments and devices would be given to all of us without any information as to the safety, effectiveness, and feasibility. No information would exist to understand how much to give, and whether it will help or hurt us.
The governing body of such developments (the FDA) would have nothing to assess the clinical value of science, thus would have no standards regulating development. Valuable time would be wasted on attempting the enormous, uncontrolled production of “possibilities.”
Is a research patient a “guinea pig?” No. There’s no denying that the ultimate purpose of a clinical trial is to answer a medical question. People who take part in clinical trials may need to do certain things or have certain tests done to stay in the study. But this does not mean that you will not receive excellent, compassionate care while in the study. In fact, most people enrolled in clinical trials appreciate the extra attention they receive from their health care team. A recent study (2005) surveyed over 1,700 people with cancer concerning their awareness and attitudes about clinical trials. Only a small portion took part in clinical trials. But most of those who did were very satisfied: 96 percent said they were treated with dignity and respect, 92 percent said they had a positive experience, and 91 percent would recommend that family or friends take part in a clinical trial if faced with cancer.
How do I learn about clinical trials that might be available to me?
Call The Christ Hospital Research Offices at 513-585-0844 for more information or click
here for a list of current clinical trials being conducted at Christ Hospital.
- Visit The Christ Hospital Cancer Center Research Offices (the front desk will assist you) for the opportunity to discuss the trials in person.
- Ask your doctor about possible clinical trials available to you.
- Search the Internet for cancer clinical trails. The National Cancer Institute (NCI) web sites for comprehensive clinical trials information: http://cancertrials.nci.nih.gov
- Call the NCI at 1-800-4-CANCER (1-800-422-6237) to have information sent to you in the mail.