How is a Drug Approved?
Before a drug company can begin testing compounds on human participants, it must conduct preclinical or laboratory research. This research typically involves testing on animal and human cells. If this stage of testing is successful, the pharmaceutical company gives the information to the Food and Drug Administrative (FDA) and requests approval to begin testing the medicine in humans.
The clinical testing of experimental medicines is usually done in three phases, each phase involving a larger number of people. If the FDA grants a New Drug Approval (NDA), drug companies will also conduct post marketing or late phase III / phase IV studies.
Phase I Studies
Phase I studies are concerned with looking at the medicine’s safety. This first phase of testing in humans is done in a small number of healthy volunteers. The study is designed to determine what happens in the human body - how the medication is absorbed, used and eliminated. A phase I study evaluates side effects, which occur as the amount of medicine is increased. This phase of testing usually takes several months and is done on an inpatient basis. Heartland does not participate in Phase I studies.
Phase II Studies
Investigational medicines must be tested for effectiveness, and continue to be tested for safety and side effects. This second phase of testing may last from several months to several years and involve up to several hundred patients. Most phase II studies involve more than one group of participants. Assigned by chance, one group of participants will receive the experimental medicine, while a second ‘control’ group will receive a standard treatment or placebo. A placebo is a substance containing no active ingredients. Often these studies are ‘blinded’- neither the participants nor the researchers know who is getting the experimental medicine.
Phase III Studies
In a phase III study, a medicine is tested in several hundred to several thousand patients. This large-scale testing tries to provide the drug company with a more complete understanding of the medicine’s effectiveness, benefits and range of possible side effects. Once a phase III study is successfully completed, a drug company can request FDA approval for marketing the medicine.
Late Phase III / Phase IV Studies
In late phase III/ Phase IV studies, drug companies have several objectives:
1. To compare an approved medicine with other medicines already on the market.
2. To monitor an approved medicine’s long-term effectiveness and impact on a patients quality of life.
3. To determine how cost effective it would be to market the approved medicine. |
