The MidAmerica Neuroscience Research Foundation is a not-for-profit, 501(c)(3) organization dedicated to finding treatments and cures for Neurological disease. As such, it carries out both basic science and clinical trial research.
A clinical trial is a carefully conducted investigation, monitored by the FDA, to test new treatments and drug therapies in human subjects. Medication trials fall into three basic categories: Phase I, Phase II, and Phase III trials.
Phase I trials are usually safety studies for promising medications that have passed the hurdles in animal safety specified by the FDA. These trials test the safety of medications in humans, often healthy subjects.
Phase II studies are generally dose-finding studies to see which doses of medication seem to work best, and with the least toxicity.
Phase III studies generally compare the medication to another drug or placebo.
Only after passing all these Phases can a drug be considered for approval by the FDA. There are many variations of these Phases.
A new type of trial design, called Adaptive Trial Design, sets up goals for safety and success ahead of time, and monitors safety and effectiveness continually during the trial using separate monitoring boards.
Thus, a study can be adapted during the trial, if the adaptive trial design is used. Generally, this type of trial, if it can be done, is much less expensive, much shorter, and is the trial design of the future.
But however the FDA approval process occurs, to take a drug through the FDA approval process costs hundreds of millions of dollars. This is in contrast to the FDA device approval process, which is generally a much shorter, and less exacting, process. The FDA approval of devices has come under considerable scrutiny and criticism recently.
The short answer is potentially to improve your own health, and the health of others. Trials are carried out with Good Clinical Practice and under the guidelines for protection of human subjects agreed to internationally. They must be approved by an Institutional Review Board, that guarantees protection of patient rights and ensures they are enrolled in a trial only after informed consent is obtained. Patients may leave the trial at any time for any reason even after enrolling in a study. There is no obligation to continue the study.
Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future (Information from National Institutes of Health).