Clinical Trial Primer
What are clinical trials?
Clinical trials are controlled evaluations of new therapies. Controlled clinical trials were first suggested in the 1930's by the British statistician Austin Bradford Hill. Their use spread slowly in the 1950's. More than 41,000 clinical trials are now underway around the world.
They are usually organized into four phases: Phase I, Phase II, Phase III and Phase IV. After an investigational drug has passed numerous animal and laboratory tests for safety and beneficial effect, the drug enters phase I. In phase I the drug is given to normal volunteers to test its safety in people. If the drug proves safe in normal people it is given in different doses to people with the disease of interest. This is phase II. Once the most effective dose has been identified the drug enters phase III. In phase III it is given to large numbers of people (generally more than 1000) to see if it is truly effective and safe in treating a specific disease. Once the drug successfully passes phase III, it will usually be approved by the FDA for use by all physicians in treating that disease. Phase IV trials usually are conducted for marketing purposes after the drug has been approved by the FDA.
What is a placebo?
A placebo is an inert substance, such as a sugar pill, that is expected to have no effect on the patient. It looks just like the active drug. In drug studies the investigational medication will be tested against the standard therapy or a placebo to verify if the investigational medicine had any effect.
What does double blind and single blind mean?
A double blind drug study means both the investigator and the patient do not know if the patient is taking either the investigational medicine or the standard treatment/placebo. In single blind clinical trials the investigator will know which therapy the patients are taking.
What is informed consent?
Informed consent is a document used to "inform" the participating patients to various aspect of a study. The document will explain the purpose of the study, the drugs being studied, and visits required of the patients. It will also describe the potential risks or side effects as well as the potential benefits of participating in the study. Most clinical trials involve participants with competent mental ability that can understand the document. It is the first step to any clinical trial and is signed by the investigator (doctor), the patient, and a witness.
What will it cost me to participate?
You will incur no cost from participating. In addition, a small stipend is usually paid to you for participation.
Where is C.A.R.E. Clinical Research?
The office is located at 522 North New Ballas Road St. Louis, MO 63141. It is staffed by trained physicians and nurses. Dr. Hyers is board-certified in internal medicine, pulmonary medicine, and virtual care medicine. He has had fifteen years experience in supervising phase III clinical research.
Will I always receive the new drug being tested?
Not always. In some studies you may receive the current best drug for comparison with the new drug. In other cases where there is no proven treatment, you may receive a placebo. Which group you fall into is chosen randomly by a computer. This process is called "randomization." In either case you will receive careful and attentive medical monitoring.
Will my doctor know about my care?
Yes. Your doctor will be kept informed. When the study is completed, you and your doctor will receive a summary of the results.
Read about clinical trials offered at this site.