Testing Drugs in Clinical Trials
The Food and Drug Administration, or FDA, is the federal agency responsible for making sure that foods and cosmetics are safe, and that drugs and medical devices are safe and effective. Clinical trials are a key part of drug discovery and development, and the FDA requires that new drugs be tested in clinical trials before they are put on the market. A clinical trial is a research study to find out if a new drug or treatment is both safe and effective for people to use.
Clinical trials are sponsored or funded by pharmaceutical companies, federal agencies like the National Institutes of Health, foundations, individuals, and voluntary groups. Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
Clinical trials are used to test new therapies and to compare existing drugs. Their goal is always see which medication or combination of medications is the safest or most effective for treating a particular ailment.
Both prescription drugs and over-the-counter drugs are tested in clinical trials before they become available to the public. However, according to a 1994 law, ingredients used in dietary supplements no longer have to be tested in clinical trials before they go on the market. Also, there are no regulations that govern the way these substances are manufactured.
Before Drugs are Tested in People
Scientists usually do years of experiments in the laboratory and in animals before they can even consider testing an experimental medication in people. Most of this early research occurs at universities and medical centers across the country and much of it is funded by the National Institutes of Health.
Most of the medicines tested in scientists' laboratories fail in laboratory or animal studies, and it can take years to bring a new medicine from the laboratory to your local pharmacy.
Developing drugs is a time-consuming and expensive process. Yet, clinical trials are the only way doctors can know for sure whether medicines are both safe and effective in people.
Protecting Clinical Trial Participants
Enrolling in a clinical trial offers benefits and risks. If you choose to participate in a clinical trial, you may get therapies not yet available to most patients. Also, patients in clinical trials are watched very closely, and they typically benefit from a high standard of care.
Importantly, scientists who wish to test drugs in people must follow strict rules that are designed to protect those who volunteer to participate in clinical trials. Special groups called Institutional Review Boards, or IRBs, evaluate all proposed research that involves human volunteers or patients.
The goal of an IRB is to make sure that the risks to humans are minimized and that these risks are reasonable compared to the knowledge researchers expect to gain by doing the study. Clinical studies cannot go forward without IRB approval.