Clinical Trials 101
Medical research studies are pertinent to helping scientists and doctors find medicine that works well for a variety of ailments and disorders. In clinical drug development, informed consent is crucial for success. Informed consent is so important that in the 9th revision of the American Psychological Association’s Ethical Code it has its own section, 8.02. If researchers plan on using children, defined as anyone younger than 18, in a study, they are legally required to obtain consent from their parent or guardian of the child.
What To Expect During A Medical Research Study
Participants will be informed of the procedures of a medical research study shortly after being selected, or shortly before beginning the clinical study.
1) In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20?80) for the first time. The purpose is to evaluate its safety and identify side effects.
2) In Phase II trials, the experimental drug or treatment is administered to a larger group of people (100?300) to determine its effectiveness and to further evaluate its safety.
3) In Phase III trials, the experimental drug or treatment is administered to large groups of people (1,000?3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the experimental drug or treatment to be used safely.
4) After completing Phase IV, the clinical trial team submits a New Drug Application (NDA) for approval to go on the market. Of the 5,000-10,000 drugs that annually enter RandD, only 250 make it to pre-clinical trial testing; only five make it to clinical trial testing; and only one makes it to FDA approval.
Why Participate In Medical Research Studies?
There are many reasons why a person would want to participate in a medical research study. Some 46 percent somewhat agree that taking part in clinical trials is as valuable to health care system as giving blood. Clinical trials, evening the phase 1 clinical trial, assist in the research needed to expand the medical world. A small amount of time donated by a civilian has the ability to change the history of medicine.
Clinical Trials 101