What You Need to Know About Informed Consent

Clinical trials

What You Need to Know About Informed Consent

Clinical drug development is crucial to the advancement of health and wellness in the modern world. Some 46 percent somewhat agree that taking part in clinical trials is as valuable to health care system as giving blood. These medical research studies focus on improving lives with medicine. 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.

Who Can Participate in Clinical Trials?

Essentially, anyone can participate in a clinical study. 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. These clinical trials are aimed toward people of all ages and sometimes need particular age groups to test their products on.

What to Expect When You Enroll in a Trial

Clinical drug development has drastically changed over time, including the length of the trial at hand. In 1999, a clinical trial lasted 460 days, whereas in 2005, a clinical trial lasted 780 days. In order to monitor the safety and effectiveness of a drug during clinical drug development, scientists start small with test groups, such as in the phase 1 clinical trial, and grow the number of participants over time. 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. 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. 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. 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.

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