Patients
More About Clinical Trials:
Medical Research South participates in phase II to IV clinical trials. Below is a basic overview of each phase:
Phase I:
Phase I marks the beginning of clinical trials in human volunteers. A small group of people, usually between 20 and 100 subjects, are treated with the new medication or treatment. The purpose of this phase is to determine how a particular medication or treatment works with the body. It is at this point that the safety of the medication or treatment is determined, dosage levels are established, and side effects are identified.
Phase II:
Phase II trials go a bit further. These trials generally enroll between 100 and 300 patient volunteers. The goal of this phase is to determine the effectiveness of the medication or treatment being investigated. Clinical trials for medications and treatments in this phase can last several months to several years. These trials are often randomized trials, which means patients are randomly placed in groups that receive different medicines and/or treatments. For example, one group receives the experimental drug and the other group serves as the "control" group and receives a placebo, or a pill that contains no active medication. These trials are often double blinded, which means neither the patient nor the clinical study team (physician and clinical research coordinator) know which group the patient is participating in.
Phase III:
Phase III trials generally involve several hundred to several thousand patients. During this phase large scale testing is performed and the trials may last several years. With more participants, the pharmaceutical companies have a better grasp on the effectiveness of the medication, the benefits, and the possible risks associated with the medication being investigated. At this point, pharmaceutical companies are also comparing their medication to others that are already on the market. Most of the trials performed are randomized and blinded trials. At the completion of a phase III trial a pharmaceutical company is able to request FDA approval so that they can market the medication or device to the general population.
Phase IV:
Phase IV trials are usually post-approval clinical trials (medications already approved by the FDA). Pharmaceutical companies compare their medication (already approved by the FDA) to other medications already on the market. Phase IV trials determine which products work better for the patient, as well as, the product's cost effectiveness. In addition, pharmaceutical companies conduct Phase IV trials to determine a medication's long term effectiveness and how the medication affects a patients day-to-day activities and quality of life.
Where can I get more information on Clinical Trials?:
- Medical Research South is currently enrolling patient volunteers for the following medical conditions.
