Taking Medicines
Testing Medicines
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 with people to find out if a new drug or treatment is both safe and effective.
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.
Along with seeking new therapies, researchers sometimes perform clinical trials to compare existing drugs. This way, they can 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 like drugs before they go on the market, so they are not tested in clinical trials. 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. The National Institutes of Health funds much of this basic research.
According to the Pharmaceutical Research and Manufacturers of America, most of the medicines tested in scientists' laboratories fail in laboratory or animal studies. On average, only 5 out of every 5,000 potential medicines actually make it to clinical trials. And only one of these five is eventually approved for use in patients.
Ensuring Safety and Effectiveness
In 2003, the Tufts University Center for the Study of Drug Development found that a pharmaceutical company typically spends $802 million over 10 to 15 years to bring a new medicine from the laboratory to your local pharmacy.
It is true that 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.
Taking Part in Clinical Trials
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.
Protecting Clinical Trial Participants
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 with humans to determine the potential risks and expected benefits.
The goal of an IRB is to make sure that the risks to humans are minimized and that they are reasonable compared to the knowledge researchers expect to gain by doing the study. Clinical studies cannot go forward without IRB approval.
