Clinical Trials 101
A clinical study is research performed by medical professionals and scientists with groups of people in order to better understand new medicine. This clinical drug development is critical in order to bring new drugs and medicines to the public. Without the medical research studies, there would be no way of knowing what sort of reactions a drug would have on the taker. There could be adverse side affects that could possibly harm large population of people. Instead, a clinical study is performed on smaller groups of people in order to conclude what any, if any, side affects taking a certain drug or medication could cause. Starting with the phase 1 clinical trial, the outline for a general clinical study is as follows:
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.
Reasons To Participate in Clinical Trials
Some 46 percent somewhat agree that taking part in clinical trials is as valuable to health care system as giving blood. Most of the time, participates of a clinical study are chosen based on a condition they have. They are then given the drug and the results, if any, are evaluated.
Everything You Need to Know About Informed Consent
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. 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. These statutes serve as guidelines that help keep minors safe and accounted for. Without them, underage children would participate in clinical drug development without the reliable, responsible knowledge of a parent or guardian.